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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04993443
Registration number
NCT04993443
Ethics application status
Date submitted
17/05/2021
Date registered
6/08/2021
Titles & IDs
Public title
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
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Scientific title
A Single and Multiple-dose Escalation First-in-Human Study Evaluating the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Administered Via Inhalation and IV Infusion in Healthy Subjects and Patients With Mild Asthma.
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Secondary ID [1]
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LQ036A001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LQ036
Other interventions - Matching Placebo
Experimental: Active Comparator: Drug :LQ036 - Experimental, Single and Multiple Oral escalating dose
Placebo comparator: Placebo Comparator: Matching Placebo for LQ036 - Matching Placebo for LQ036: Matching Placebo
Treatment: Drugs: LQ036
For Each part of the study, a staggered dosing schedule may be used for the first dose level, in each cohort including 2 sentinel subjects (1 active and 1 placebo) initiating dosing first and the remaining 6 subjects for Part A-C and 8 subjects for Part D initiating dosing no sooner than the next day. Each study part (A, B, C, and D) will be completed sequentially, but with partial overlapping. Part B and C may only be initiated after review of the safety, tolerability, and PK data following dosing of the SAD Cohort 3 or 4.
Part D may be initiated when safety tolerability and PK data are known and deemed acceptable by the SRC for multiple doses in Part B, at least at the same concentration to be administered in Part D.
Other interventions: Matching Placebo
Matching Placebo for LQ036: Matching Placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [1]
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Assessment of outcome of Adverse events
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Timepoint [1]
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Up to 5 weeks.
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Primary outcome [2]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [2]
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Abnormal blood pressure
Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.
Part B and D: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.
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Timepoint [2]
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Up to 1 Month
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Primary outcome [3]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [3]
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Abnormal pulse rate
Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.
Part B and D: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.
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Timepoint [3]
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Up to 1 Month
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Primary outcome [4]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [4]
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Abnormal respiratory rate
Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.
Part B and D: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.
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Timepoint [4]
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Up to 1 Month
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Primary outcome [5]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [5]
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Abnormal Tympanic Temperature
Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.
Part B and D: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.
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Timepoint [5]
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Up to 1 Month
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Primary outcome [6]
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To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables.
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Assessment method [6]
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Change in electrocardiograms (ECGs).
Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 8, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.
Part B and D: At check-in (Day -1), and pre-dose and 1, 2, and 8 hours post-dose on Days 1 to 12, and at discharge (Day 13), and on Days 15±1, 22±1, and 29±1.
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Timepoint [6]
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Up to 1 Month
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Primary outcome [7]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [7]
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Assessment of abnormal clinical laboratory tests (hemoglobin)
Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
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Timepoint [7]
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Up to 5 Weeks
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Primary outcome [8]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [8]
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Assessment of abnormal clinical laboratory tests (hematocrit)
Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
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Timepoint [8]
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Up to 5 Weeks
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Primary outcome [9]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [9]
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Assessment of abnormal clinical laboratory tests (mean corpuscular volume)
Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
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Timepoint [9]
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Up to 5 Weeks
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Primary outcome [10]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [10]
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Assessment of abnormal clinical laboratory tests (leukocyte counts)
Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
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Timepoint [10]
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Up to 5 Weeks
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Primary outcome [11]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [11]
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Assessment of abnormal clinical laboratory tests (platelet count)
Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
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Timepoint [11]
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Up to 5 Weeks
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Primary outcome [12]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [12]
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Assessment of abnormal clinical laboratory tests (Urea)
Part B and D: At check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
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Timepoint [12]
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Up to 5 Weeks
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Primary outcome [13]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [13]
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Assessment of abnormal clinical laboratory tests (creatinine)
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Timepoint [13]
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Up to 5 Weeks
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Primary outcome [14]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [14]
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Assessment of abnormal clinical laboratory tests (alkaline phosphatase)
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Timepoint [14]
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Up to 5 Weeks
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Primary outcome [15]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [15]
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Assessment of abnormal clinical laboratory tests (glucose)
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Timepoint [15]
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Up to 5 Weeks
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Primary outcome [16]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [16]
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Assessment of abnormal clinical laboratory tests (alanine aminotransferase (ALT))
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Timepoint [16]
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Up to 5 Weeks
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Primary outcome [17]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [17]
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Assessment of abnormal clinical laboratory tests (aspartate amino transferase (AST))
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Timepoint [17]
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Up to 5 Weeks
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Primary outcome [18]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [18]
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Assessment of abnormal clinical laboratory tests (total bilirubin)
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Timepoint [18]
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Up to 5 Weeks
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Primary outcome [19]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [19]
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Assessment of abnormal clinical laboratory tests (sodium)
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Timepoint [19]
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Up to 5 Weeks
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Primary outcome [20]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [20]
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Assessment of abnormal clinical laboratory tests (potassium)
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Timepoint [20]
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Up to 5 Weeks
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Primary outcome [21]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [21]
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Assessment of abnormal clinical laboratory tests (chloride)
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Timepoint [21]
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Up to 5 Weeks
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Primary outcome [22]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [22]
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Assessment of abnormal clinical laboratory tests (calcium)
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Timepoint [22]
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Up to 5 Weeks
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Primary outcome [23]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [23]
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Assessment of abnormal clinical laboratory tests (total proteins)
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Timepoint [23]
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Up to 5 Weeks
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Primary outcome [24]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [24]
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Assessment of abnormal clinical laboratory tests (Phosphorus)
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Timepoint [24]
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Up to 5 Weeks
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Primary outcome [25]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [25]
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Assessment of abnormal clinical laboratory tests (albumin)
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Timepoint [25]
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Up to 5 Weeks
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Primary outcome [26]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [26]
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Assessment of abnormal clinical laboratory tests (Coagulation test (aPTT (Activated partial thromboplastin time) and INR (International Normalized Ratio))
Part B and D: At screening and at study exit (Day 36±1)
Part A and C: At screening and at study exit (Day 29±1).
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Timepoint [26]
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Up to 5 Weeks
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Primary outcome [27]
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To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [27]
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Assessment of abnormal clinical laboratory tests (Urine macroscopic examination, pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, nitrite, urobilinogen, and leukocytes)
Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), and at study exit (Day 29±1).
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Timepoint [27]
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Up to 5 Weeks
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Primary outcome [28]
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To evaluate the tolerability of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [28]
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Local tolerability (oropharyngeal) assessment (Part A) and (injection site) assessment (Part C): The area where the study drug was administered will be monitored by study personnel throughout the study for any signs of local reactions such as swelling or redness.
Time frame: pre-dose, Day 1, 2, 4, 8, and 24 hours post-dose, and at Day 3.
Local tolerability (oropharyngeal) assessment (Part B and D): The area where the study drug was administered will be monitored by study personnel throughout the study for any signs of local reactions such as swelling or redness.
Time frame: pre-dose (as well as 1, 2, and 4 hours post-dose on Days 1, 3, 5, 8, and 10, 11, 13, and at day 36.
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Timepoint [28]
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Up to 5 weeks
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Primary outcome [29]
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To evaluate the immunogenicity of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [29]
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Immunogenicity data that will be evaluated include Anti-Drug Antibody test sampling (ADA).
Parts A and C: A total of 5 blood samples will be taken for ADA assessment: at pre-dose (Day 1), and on Days 8±1, 15±1, and 22±1, and at study exit (Day 29±1)
Part B and D: A total of 6 blood samples will be taken for ADA assessment: at pre-dose (Day 1), and on Days 8±1, 15±1, 22±1, 29±1, and at study exit (Day 36±1)
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Timepoint [29]
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Up to 5 Weeks
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Primary outcome [30]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects.
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Assessment method [30]
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AUC0-t: Area under the concentration-time curve from time zero until the last observed concentration
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Timepoint [30]
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Up to 2 Weeks
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Primary outcome [31]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects.
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Assessment method [31]
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AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated)
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Timepoint [31]
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Up to 2 Weeks
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Primary outcome [32]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects.
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Assessment method [32]
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Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as \[1 - (AUC0-t/AUC0-inf)\] x 100
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Timepoint [32]
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Up to 2 Weeks
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Primary outcome [33]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [33]
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AUC0-24: Area under the concentration-time curve from time zero to 24 hours post-dose.
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Timepoint [33]
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Up to 2 Weeks
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Primary outcome [34]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [34]
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AUC0-t: Area under the concentration-time curve for one dosing interval (t) at steady-state. In this study t = 24 hours (AUC0-24)
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Timepoint [34]
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Up to 2 Weeks
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Primary outcome [35]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [35]
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AUC0-72: Area under the concentration-time curve from time zero to 72 hours post-dose.
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Timepoint [35]
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Up to 2 Weeks
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Primary outcome [36]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [36]
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Cmax: Maximal observed concentration
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Timepoint [36]
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Up to 2 Weeks
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Primary outcome [37]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [37]
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Cmax ss: maximum observed concentration at steady-state
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Timepoint [37]
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Up to 2 Weeks
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Primary outcome [38]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [38]
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Cmin ss: minimum observed concentration at steady-state
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Timepoint [38]
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Up to 2 Weeks
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Primary outcome [39]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [39]
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Tmax ss: time of observed Cmax at steady-state
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Timepoint [39]
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Up to 2 Weeks
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Primary outcome [40]
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0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [40]
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Tmax: Time of Cmax
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Timepoint [40]
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0
Up to 2 Weeks
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Primary outcome [41]
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0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects
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Assessment method [41]
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0
T½ el: Terminal elimination half-life
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Timepoint [41]
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0
Up to 2 Weeks
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Primary outcome [42]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects (Kel)
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Assessment method [42]
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0
Kel: Terminal elimination rate constant
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Timepoint [42]
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0
Up to 2 Weeks
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Primary outcome [43]
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0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma (Racc)
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Assessment method [43]
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Racc: drug accumulation ratio
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Timepoint [43]
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Up to 2 Weeks
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Primary outcome [44]
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To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma. (PTF%)
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Assessment method [44]
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PTF%: peak trough fluctuation
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Timepoint [44]
0
0
Up to 2 Weeks
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Primary outcome [45]
0
0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects.
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Assessment method [45]
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0
Cl/F: Apparent body clearance, calculated as Dose / AUC0-inf
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Timepoint [45]
0
0
Up to 2 Weeks
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Primary outcome [46]
0
0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects
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Assessment method [46]
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0
Vd/F: apparent volume of distribution, calculated as Dose / Kel \* AUC0-inf
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Timepoint [46]
0
0
Up to 2 Weeks
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Primary outcome [47]
0
0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [47]
0
0
Clss/F: apparent body clearance at steady-state, calculated as dose / AUC0-inf
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Timepoint [47]
0
0
Up to 2 Weeks
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Primary outcome [48]
0
0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.
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Assessment method [48]
0
0
Vdss/F: apparent volume of distribution at steady-state, calculated as dose / (Kel \* AUC0-inf)
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Timepoint [48]
0
0
Up to 2 Weeks
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Primary outcome [49]
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0
To evaluate the change in fraction exhaled nitric oxide (FeNO) after multiple doses of LQ036 administered via inhalation in patients with mild asthma.
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Assessment method [49]
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At screening, on dosing days (Days 1 to 10, within 60 minutes prior to dosing), on Days 11, 12, and at discharge (Day 13), as well as on Days 15±1, 22±1, 29±1, and at study exit (Day 36±1).
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Timepoint [49]
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Up to 6 weeks
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Secondary outcome [1]
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To compare the PK of LQ036 after administration via inhalation and IV routes
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Assessment method [1]
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Serum levels of LQ036 will be quantified for PK analysis by a validated enzyme linked immunosorbent assay (ELISA) method.
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Timepoint [1]
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Up to 2 weeks
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Secondary outcome [2]
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0
To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (AUC0-24 versus AUC0-t)
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Assessment method [2]
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Comparisons between Day 1 and Day 10 PK parameters: AUC0-24 versus AUC0-t will be done by Analysis of variance (ANOVA)
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Timepoint [2]
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0
Up to 2 weeks
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Secondary outcome [3]
0
0
To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (Cmax versus Cmax ss)
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Assessment method [3]
0
0
Comparisons between Day 1 and Day 10 PK parameters: Cmax versus Cmax ss will be done by Analysis of variance (ANOVA)
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Timepoint [3]
0
0
Up to 2 weeks
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Secondary outcome [4]
0
0
To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (Tmax versus Tmax ss)
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Assessment method [4]
0
0
Comparisons between Day 1 and Day 10 PK parameters: Tmax versus Tmax ss will be done by Analysis of variance (ANOVA)
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Timepoint [4]
0
0
Up to 2 weeks
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Secondary outcome [5]
0
0
To compare the PK of LQ036 after administration via inhalation in healthy subjects versus patients with mild asthma.
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Assessment method [5]
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0
Serum levels of LQ036 will be quantified for PK analysis by a validated enzyme linked immunosorbent assay (ELISA) method
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Timepoint [5]
0
0
Up to 2 weeks
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Secondary outcome [6]
0
0
To compare the safety and tolerability of LQ036 via inhalation in healthy subjects versus patients with mild asthma. (AUC0-24 versus AUC0-t)
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Assessment method [6]
0
0
Comparisons between Day 1 and Day 10 PK parameters: AUC0-24 versusAUC0-t will be done by Analysis of variance (ANOVA)
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Timepoint [6]
0
0
Up to 2 weeks
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Secondary outcome [7]
0
0
To compare the safety and tolerability of LQ036 via inhalation in healthy subjects versus patients with mild asthma. (Cmax versus Cmax ss)
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Assessment method [7]
0
0
Comparisons between Day 1 and Day 10 PK parameters: Cmax versus Cmaxss will be done by Analysis of variance (ANOVA)
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Timepoint [7]
0
0
Up to 2 weeks
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Secondary outcome [8]
0
0
To compare the safety and tolerability of LQ036 via inhalation in healthy subjects versus patients with mild asthma. (Tmax versus Tmax ss)
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Assessment method [8]
0
0
Comparisons between Day 1 and Day 10 PK parameters: Tmax versus Tmaxss will be done by Analysis of variance (ANOVA)
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Timepoint [8]
0
0
Up to 2 weeks
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Eligibility
Key inclusion criteria
* Healthy as defined by:
1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
2. the absence of a clinically significant history of neurological, endocrine, cardiovascular, respiratory (except resolved childhood asthma), hematological, immunological, psychiatric (except including depression that has not required treatment for at least 6 months), gastrointestinal, renal, hepatic, and metabolic disease.
* Male or female, non-smokers or casual smokers (defined as smoking the equivalent of less than an average of 5 cigarettes per week over a 3 month period, and willing to abstain from smoking during involvement in the study and for 1 month prior to screening), =18 and =55 years of age, with BMI >18.0 and <32.0 kg/m2.
* Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
1. Simultaneous use of intrauterine device placed at least 4 weeks prior to study drug administration, and condom for the male partner;
2. Simultaneous use of hormonal contraceptives started at least 4 weeks prior to study drug administration and condom for the male partner.
3. Sterile male partner (vasectomized since at least 6 months).
* Male subjects who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration:
1. Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used since at least 4 weeks, or intra-uterine contraceptive device placed since at least 4 weeks;
2. Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
* Subjects with normal lung function defined as greater than or equal to 80% predicted forced expiratory volume in one second (FEV1).
* Males and females who are in same-sex relationships can be included. There are no mandatory contraceptive requirements for males or females in same-sex relationships.
* Male and female heterosexual subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.
* Part D only: Volunteers with mild asthma defined as:
1. Asthma diagnosed with appropriate medical documentation;
2. FEV1 =70% predicted FEV1 and FEV1/FVC ratio =0.7 at screening;
3. FeNO =35 ppb at screening;
4. Well-controlled, or partly-controlled, by as-needed use of short-acting ß2 agonists for at least 3 months prior to dosing;
5. Reversibility test at screening consistent with diagnosis of asthma (=12% and 200 mL increase in FEV1 over the baseline value).
* Capable of consent
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found at screening or at check-in (Day -1, not applicable to serology assessments).
* Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of check-in, or planned inpatient surgery or hospitalization during the study period.
* Any history of malignancy or neoplastic disease (not including excised, non-recurrent, non-melanoma skin cancers).
* Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or at check-in (Day -1).
* History of allergic reactions to LQ036, to any biologic therapy, or other related drugs, or to any excipient in the formulation.
* Positive pregnancy test at screening or at check-in (Day -1)
* Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure less than 90 or greater than 140 mmHg, diastolic blood pressure less than 40 or greater than 90 mmHg, or heart rate less than 40 or greater than 100 bpm) at screening.
* History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit. Regular use of alcohol is defined as greater than 14 units of alcohol per week, where 1 unit is defined as 100 mL of wine at 13.5% a/v, 375 mL of beer at 3.5% a/v, or 30 mL of spirit at 40% a/v.
* History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as tetrahydrocannabinol) within 1 month prior to the screening visit or hard drugs (amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, and phencyclidine) within 3 months prior to screening.
* Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
* Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
1. Prescription medications (except for hormonal contraceptives in all study parts and short-acting ß2 agonists for patients in Part D) within 14 days prior to the first dosing;
2. Over-the-counter products and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to the first dosing, with the exception of the occasional use of paracetamol/acetaminophen (up to 2 g daily), ibuprofen (up to 800 mg daily), and oral contraceptives;
3. Depot injection or implant (except for hormonal contraceptives) of any drug within 3 months prior to the first dosing;
4. Long-acting ß2 agonists for 4 weeks prior to screening;
5. Anti-immunoglobulin E,anti-Interleukin-5, or anti-Interleukin-4 Receptor therapy for 6 months prior to screening;
6. Inhaled corticosteroids (greater than 500 µg/day of beclometasone dipropionate or equivalent) within 16 weeks prior to screening,
7. Oral or injectable steroids for the treatment of asthma or respiratory tract infection within 5 years prior to screening;
8. Intranasal steroids within 4 weeks prior to screening;
9. Topical steroids within 4 weeks prior to screening;
10. Leukotriene antagonists within 2 weeks prior to screening;
11. Anticholinergics or cromoglycate within 1 week prior to screening.
12. Inhaled short-acting ß2 agonists (such as salbutamol) within 6 months prior to screening (not applicable to patients in Part D).
* Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
* Breast-feeding subject.
* History of latent or active tuberculosis, or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening.
* Positive QuantiFERON®-TB test indicating possible tuberculosis infection.
* Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the course of the study.
* Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
* History of clinically significant opportunistic infection (e.g., invasive candidiasis or one pneumocystis pneumonia).
* History of parasitic diseases (e.g., toxoplasmosis, cysticercosis, toxocariasis).
* History of frequent, recurrent herpes simplex.
* Presence of fever (body temperature greater than 37.6 °C) e.g., a fever associated with a symptomatic viral or bacterial infection, within 2 weeks prior to the first dosing.
* Life threatening asthmatic episode at any time in the past.
* C-reactive protein level above 5 mg/L.
* Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/03/2023
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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0
Q-Pharm Pty Ltd (Nucleus Network Brisbane) - Brisbane
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Recruitment hospital [2]
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0
Nucleus Network Melbourne - Melbourne
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Recruitment postcode(s) [1]
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0
4006 - Brisbane
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Recruitment postcode(s) [2]
0
0
3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Syneos Health
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
Shanghai Novamab Biopharmaceuticals Co. Ltd.
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Address [1]
0
0
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Country [1]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
This is Phase I first-in-human trial evaluating the safety, tolerability, immunogenicity, and pharmacogenomics of LQ036 via inhalation and IV infusion. The study will be divided into 4 parts: Single Ascending Dose, Multiple Ascending Dose, and Intra Venous with a target of 88 healthy volunteers and 30 patients with mild Asthma.
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Trial website
https://clinicaltrials.gov/study/NCT04993443
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Huaiyu Gu
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Address
0
0
Shanghai Novamab Biopharm Co., Ltd.
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04993443