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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06038279
Registration number
NCT06038279
Ethics application status
Date submitted
31/07/2023
Date registered
14/09/2023
Titles & IDs
Public title
Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis.
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Scientific title
A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis.
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Secondary ID [1]
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INI-2004-101
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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:
Allergic Rhinitis Due to Weed Pollen
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Allergic Rhinitis
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Condition category
Condition code
Inflammatory and Immune System
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Allergies
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - INI-2004
Treatment: Drugs - Placebo
Experimental: Arm 1 (SAD)- INI-2004 Dose Cohort 1 - Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo).
Experimental: Arm 2 (SAD)- INI-2004 Dose Cohort 2 - Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo).
Experimental: Arm 3 (SAD)- INI-2004 Dose Cohort 3 - Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo).
Experimental: Arm 4 (SAD)- INI-2004 Dose Cohort 4 - Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo).
Placebo comparator: Placebo - Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo).
Experimental: Arm 1 (MAD) - INI-2004 Dose Cohort 1 - Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks.
Experimental: Arm 2 (MAD) -INI-2004 Dose Cohort 2 - Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks.
Experimental: Arm 3 (MAD) - INI-2004 Dose Cohort 3 - Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks.
Placebo comparator: Placebo (MAD) - Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks.
Treatment: Drugs: INI-2004
INI-2004 (a toll-like receptor \[TLR\]4 agonist) liposomal formulation. INI-2004 is an intranasal (IN) TLR4 agonist that is targeted to prevent AR symptoms in subjects with seasonal AR.
Treatment: Drugs: Placebo
The Placebo for INI-2004 is a clear, colorless solution free of particles supplied in 10 mL glass vials with a 10 mL fill.
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Intervention code [1]
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Treatment: Drugs
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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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Incidence, severity and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment after a single ascending Dose (SAD)
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Assessment method [1]
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Graded using 5-point scale
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Timepoint [1]
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Baseline, Day 1 then daily through to Day 7 End of Study Visit
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Primary outcome [2]
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Incidence, severity and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment after multiple ascending doses (MAD)
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Assessment method [2]
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Graded using 5-point scale
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Timepoint [2]
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Baseline = Day 0, Day 14, 21, 28, 35 through to Day 58 End of Study Visit
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Primary outcome [3]
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Number of Participants with a Change from baseline in Vital signs measurements after a single ascending Dose (SAD)
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Assessment method [3]
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Pulse rate \[PR\], systolic and diastolic blood pressure \[BP\], temperature, respiratory rate.\[RR\] and oxygen saturation. Blood pressure will be measured using a sphygmomanometer, body temperature will be measured using a thermometer, Heart rate (HR) is measured using vital sign machine, respiratory rate is measured manually via 60-second count and oxygen saturation is measured using a Oximeter. All abnormal assessments measured as Clinically significant post dose will be recorded as AEs.
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Timepoint [3]
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Baseline, Day 1 through to Day 7 End of Study Visit
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Primary outcome [4]
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Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses (MAD)
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Assessment method [4]
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Pulse rate \[PR\], systolic and diastolic blood pressure \[BP\], temperature, respiratory rate.\[RR\] and oxygen saturation. Blood pressure will be measured using a sphygmomanometer, body temperature will be measured using a thermometer, Heart rate (HR) is measured using vital sign machine,respiratory rate is measured manually via 60-second count.\[RR\] and oxygen saturation is measured using a Oximeter. All abnormal assessments measured as Clinically significant post dose will be recorded as AEs.
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Timepoint [4]
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Baseline = Day 0 through to Day 58 End of Study Visit
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Primary outcome [5]
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Change from baseline in 12-lead electrocardiogram parameters after a single ascending Dose (SAD)
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Assessment method [5]
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12-lead ECGs parameters include but not limited to the measurements of ventricular HR, PR interval, RR interval, QRS duration, QT interval and QTcF. At each protocol scheduled timepoint, ECGs will be performed in triplicate with each replicate separated by at least 1 minute and the full set of triplicates completed within 5 minutes.All Clinically Significant findings post-dose will be recorded as AEs.
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Timepoint [5]
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Baseline, Day 1 through to Day 7 End of Study Visit
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Primary outcome [6]
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Change from baseline in 12-lead electrocardiogram parameters after multiple ascending doses (MAD)
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Assessment method [6]
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12-lead ECGs parameters include but not limited to the measurements of ventricular HR, PR interval, RR interval, QRS duration, QT interval and QTcF. At each protocol scheduled timepoint, ECGs will be performed in triplicate with each replicate separated by at least 1 minute and the full set of triplicates completed within 5 minutes.All Clinically Significant findings post-dose will be recorded as AEs.
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Timepoint [6]
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Baseline = Day 0 through to Day 58 End of Study Visit
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Primary outcome [7]
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Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
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Assessment method [7]
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Hematology - Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse events. The severity of each AE and SAE will be graded using a 5-point scale
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Timepoint [7]
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Baseline, Day 2 through to Day 7 End of Study Visit
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Primary outcome [8]
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Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
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Assessment method [8]
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Serum chemistry- Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
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Timepoint [8]
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Baseline, Day 2 through to Day 7 End of Study Visit
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Primary outcome [9]
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Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
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Assessment method [9]
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Urinalysis- Urine samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
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Timepoint [9]
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Baseline, Day 2 through to Day 7 End of Study Visit
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Primary outcome [10]
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Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
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Assessment method [10]
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Hematology - Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
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Timepoint [10]
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Baseline = Day 0, Day 14 and Day 58 End of Study Visit
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Primary outcome [11]
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Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
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Assessment method [11]
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Serum chemistry- Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
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Timepoint [11]
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Baseline = Day 0, Day 14 and Day 58 End of Study Visit
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Primary outcome [12]
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Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
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Assessment method [12]
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Urinalysis- Urine samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse event. The severity of each AE and SAE will be graded using a 5-point scale
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Timepoint [12]
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Baseline = Day 0, Day 14 and Day 58 End of Study Visit
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Primary outcome [13]
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Change from baseline in Nasal symptoms after a single ascending Dose (SAD)
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Assessment method [13]
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Presence of itching, discomfort, rhinorrhoea, congestion and sneezing are assessed using a 10 cm visual analogue scale \[VAS\]. The participant will mark on the VAS where they rank their symptoms ranging from "no symptoms" to "worst symptoms ever experienced".
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Timepoint [13]
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Baseline, Day 1 through to Day 7 End of Study Visit
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Primary outcome [14]
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Change from baseline in Nasal symptoms after multiple ascending doses (MAD)
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Assessment method [14]
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Presence of itching, discomfort, rhinorrhoea, congestion and sneezing are assessed individually as a Total Nasal Symptoms Score (TNSS) at different time points pre and post-ragweed allergen challenge in the MAD portion of the study. TNSS is the sum of symptoms scores for nasal congestion, rhinorrhoea, nasal itching, and sneezing (each scored on a scale of 0 to 3 (below) with total possible score of 0 to 12. The criterion used to score each symptom is described below:
0 = none: no symptoms
1. = mild
2. = moderate
3. = severe
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Timepoint [14]
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Baseline = Day 0 through to Day 58 End of Study Visit
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Primary outcome [15]
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Change from baseline in Nasal irritancy after a single ascending Dose (SAD)
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Assessment method [15]
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Nasal examination
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Timepoint [15]
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Baseline, Day 1 through to Day 7 End of Study Visit
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Primary outcome [16]
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Change from baseline in Nasal irritancy after multiple ascending doses (MAD)
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Assessment method [16]
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Nasal examination
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Timepoint [16]
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Baseline = Day 0 through to Day 58 End of Study Visit
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Primary outcome [17]
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Change from baseline in Spirometry after a single ascending Dose (SAD)
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Assessment method [17]
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Peak expiratory flow \[PEF\]-Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for PEF will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for PEF is l/min.
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Timepoint [17]
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Baseline, Day 1 through to Day 7 End of Study Visit
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Primary outcome [18]
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Change from baseline in Spirometry after a single ascending Dose (SAD)
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Assessment method [18]
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Forced expiratory volume in 1 second \[FEV1\]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEV1 will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1 is liters.
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Timepoint [18]
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Baseline, Day 1 through to Day 7 End of Study Visit
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Primary outcome [19]
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Change from baseline in Spirometry after a single ascending Dose (SAD)
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Assessment method [19]
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Forced vital capacity \[FVC\]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FVC will be summarised at each scheduled time point using descriptive statistics. Units of measurement used for FVC is liters.
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Timepoint [19]
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Baseline, Day 1 through to Day 7 End of Study Visit
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Primary outcome [20]
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Change from baseline in Spirometry after a single ascending Dose (SAD)
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Assessment method [20]
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Forced expiratory flow over the middle one-half of the FVC \[FEF25-75%\]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for spirometry assessments FEF25-75% will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1/FVC is %.
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Timepoint [20]
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Baseline, Day 1 through to Day 7 End of Study Visit
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Primary outcome [21]
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0
Change from baseline in Spirometry after a single ascending Dose (SAD)
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Assessment method [21]
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FEV1/FVC ratio- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for spirometry assessments FEV1/FVC ratio will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEF 25%-75% is l/s.
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Timepoint [21]
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Baseline, Day 1 through to Day 7 End of Study Visit
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Primary outcome [22]
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Change from baseline in Spirometry after multiple ascending doses (MAD)
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Assessment method [22]
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Peak expiratory flow \[PEF\]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for PEF will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for PEF is l/min.
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Timepoint [22]
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Baseline = Day 0 through to Day 58 End of Study Visit
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Primary outcome [23]
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Change from baseline in Spirometry after multiple ascending doses (MAD)
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Assessment method [23]
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Forced expiratory volume in 1 second \[FEV1\]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEV1 will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1 is liters.
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Timepoint [23]
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Baseline = Day 0 through to Day 58 End of Study Visit
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Primary outcome [24]
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Change from baseline in Spirometry after multiple ascending doses (MAD)
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Assessment method [24]
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Forced vital capacity \[FVC\]- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FVC will be summarised at each scheduled time point using descriptive statistics. Units of measurement used for FVC is liters.
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Timepoint [24]
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Baseline = Day 0 through to Day 58 End of Study Visit
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Primary outcome [25]
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0
Change from baseline in Spirometry after multiple ascending doses (MAD)
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Assessment method [25]
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FEF25-75% - Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEF25-75%, will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEV1/FVC is %.
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Timepoint [25]
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Baseline = Day 0 through to Day 58 End of Study Visit
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Primary outcome [26]
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0
Change from baseline in Spirometry after multiple ascending doses (MAD)
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Assessment method [26]
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FEV1/FVC ratio- Pulmonary function will be assessed using a handheld spirometer at the time points indicated. A minimum of 3 readings should be completed and recorded at each time point. Observed values and changes from baseline for FEV1/FVC ratio will be summarised at each scheduled time point using descriptive statistics. Unit of measurement used for FEF 25%-75% is l/s.
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Timepoint [26]
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Baseline = Day 0 through to Day 58 End of Study Visit
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Secondary outcome [1]
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Effectiveness of INI-2004 on nasal congestion will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 14, 21, 23, 28, 35, 37, 51 and 58 compared to baseline (Day 0)
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Assessment method [1]
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Determined by acoustic rhinometry. Acoustic rhinometry will be performed using GM Instruments. Measurements to include (at a minimum) nasal volume and cross-sectional area. Measurements will be performed for both left and right nasal cavities independently.
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Timepoint [1]
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Baseline = Day 0 through to Day 58
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Secondary outcome [2]
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Effectiveness of INI-2004 on peak nasal inspiratory flow will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 14, 21, 23, 28, 35, 37, 51 and 58 compared to baseline (Day 0)
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Assessment method [2]
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Peak nasal inspiratory flow to be determined using the mean of three replicates.
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Timepoint [2]
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Baseline = Day 0 through to Day 58
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Secondary outcome [3]
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Effectiveness of INI-2004 on nasal symptoms will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0)
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Assessment method [3]
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Total nasal symptom score \[TNSS\] will be measured on a scale of 0 to 3 with a total possible score of 0 to 12. 0= none, no symptoms, 1= mild, 2= moderate, 3=severe.
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Timepoint [3]
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Baseline = Day 0 through to Day 58
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Secondary outcome [4]
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Effectiveness of INI-2004 on nasal irritancy will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0)
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Assessment method [4]
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Nasal examination- A macroscopic nasal examination will be performed, including conventional anterior rhinoscopy using an otoscope with an attached otic speculum (or nasal speculum and headlight) to assess swelling of the mucosa, erythema, and secretions. All post-dose CS events will be recorded as AEs.
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Timepoint [4]
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Baseline = Day 0 through to Day 58 End of Study Visit
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Secondary outcome [5]
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The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51, and 58 compared to baseline (Day 0) via PEF
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Assessment method [5]
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PEF- Unit of measurement or PEFis l/min
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Timepoint [5]
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Baseline = Day 0 through to Day 58
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Secondary outcome [6]
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The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) Via FEV1
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Assessment method [6]
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FEV1- FEV1 is measured in liters
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Timepoint [6]
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Baseline = Day 0 through to Day 58
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Secondary outcome [7]
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The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FVC
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Assessment method [7]
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FVC is measured in liters
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Timepoint [7]
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0
Baseline = Day 0 through to Day 58
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Secondary outcome [8]
0
0
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FEV1/FVC ratio
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Assessment method [8]
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FEV1/FVC- is measured in %
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Timepoint [8]
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0
Baseline = Day 0 through to Day 58
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Secondary outcome [9]
0
0
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FEF
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Assessment method [9]
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FEF 25%-75%- is measured as l/s
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Timepoint [9]
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0
Baseline = Day 0 through to Day 58
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Secondary outcome [10]
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0
Single dose PK parameters: maximum observed concentration (Cmax)
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Assessment method [10]
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0
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
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Timepoint [10]
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Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
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Secondary outcome [11]
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Single dose PK parameters: Time to Cmax (Tmax)
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Assessment method [11]
0
0
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
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Timepoint [11]
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0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
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Secondary outcome [12]
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0
Single dose PK parameters: Area under the concentration-time curve from time 0 to time t (AUC0-t)
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Assessment method [12]
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0
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
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Timepoint [12]
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0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
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Secondary outcome [13]
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0
Single dose PK parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast)
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Assessment method [13]
0
0
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
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Timepoint [13]
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0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
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Secondary outcome [14]
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0
Single dose PK parameters: Half-life (t1/2)
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Assessment method [14]
0
0
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
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Timepoint [14]
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Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
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Secondary outcome [15]
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Single dose PK parameters: Clearance (Cl/f)
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Assessment method [15]
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0
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
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Timepoint [15]
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Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
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Secondary outcome [16]
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0
Single dose PK parameters: Volume of distribution (Vz/f)
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Assessment method [16]
0
0
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
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Timepoint [16]
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0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
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Secondary outcome [17]
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0
Single dose PK parameters: Area under the drug concentration-time curve from time zero infinity (AUCinf)
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Assessment method [17]
0
0
Pharmacokinetics (PK) of INI-2004 in blood plasma following single dose
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Timepoint [17]
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0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
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Secondary outcome [18]
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0
Multiple dose PK parameters: Drug concentrations from pre-dose to 4 hours post-dose on Days 14 and 35.
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Assessment method [18]
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0
Pharmacokinetics (PK) of INI-2004 in blood plasma following multiple doses
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Timepoint [18]
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Day 14 pre dose then 1, 2 and 4 hours post-dose, Day 35 pre dose then 1, 2 and 4 hours post-dose
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Secondary outcome [19]
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Multiple dose PK parameters: AUC0-4 on Days 14 and 35 (if data permits)
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Assessment method [19]
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0
Pharmacokinetics (PK) of INI-2004 in blood plasma following multiple doses
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Timepoint [19]
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0
Day 14 pre dose then 1, 2 and 4 hours post-dose, Day 35 pre dose then 1, 2 and 4 hours post-dose
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Secondary outcome [20]
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Multiple dose PK parameters: Post-dose urine drug concentration on Day 14.
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Assessment method [20]
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Pharmacokinetics (PK) of INI-2004 in urine following multiple doses - decision if endpoint will be evaluated will be determined following review of plasma PK data from Phase I (SAD).
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Timepoint [20]
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Urine to be collected at 0-2 hours post-dose interval on Day 14 only.
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Secondary outcome [21]
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Single dose PD parameters: Changes in cytokine levels in nasal secretions post-dose compared to baseline pre-dose.
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Assessment method [21]
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0
Pharmacodynamics (PD) of INI-2004 in nasal secretions following single dose
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Timepoint [21]
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0
Baseline Day 1 pre-dose then 4, 24 and 48 hours post-dose.
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Secondary outcome [22]
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0
Single dose PD parameters: Changes in cytokine levels in plasma post-dose compared to baseline pre-dose.
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Assessment method [22]
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0
Pharmacodynamics (PD) of INI-2004 in blood plasma following single dose
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Timepoint [22]
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0
Baseline Day 1 pre-dose then 4, 24 and 48 hours post-dose.
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Secondary outcome [23]
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0
Multiple dose PD parameters: Changes in concentrations of pro-inflammatory cytokines and nasal mediators in nasal secretions following dose administration compared to baseline pre-dose.
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Assessment method [23]
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0
Pharmacodynamics (PD) of INI-2004 in nasal secretions following multiple doses
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Timepoint [23]
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0
Baseline pre-dose on Day 14 and 35, post-dose Days 14 and 35.
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Secondary outcome [24]
0
0
Multiple dose PD parameters: Changes in concentrations of pro-inflammatory cytokines and nasal mediators in plasma following dose administration compared to baseline pre-dose.
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Assessment method [24]
0
0
Pharmacodynamics (PD) of INI-2004 in blood plasma following multiple doses
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Timepoint [24]
0
0
Baseline pre-dose on Day 14 and 35, post-dose Days 14 and 35.
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Eligibility
Key inclusion criteria
Inclusion Criteria (Phase 1):
1. Participant is willing to refrain from consuming food or beverages containing caffeine and/or xanthene products, within 24 hours prior to check-in on Day -1.
2. Female participants must be of non-child-bearing potential i.e., surgically sterilised at least 6 weeks before the screening visit or postmenopausal.
Inclusion Criteria Phase Ib (Multiple Ascending Dose)
1. Minimum 2 year history of ragweed-induced AR requiring pharmacotherapy (self-reported history accepted) and a positive ragweed skin prick test reaction at Screening Visit.
2. Participant is willing to refrain from consuming food or beverages containing caffeine, within 24 hours prior to each clinic visit.
3. Female participants must be of non-child-bearing potential i.e., surgically sterilised or postmenopausal.
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Minimum age
18
Years
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Maximum age
64
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
Exclusion Criteria Phase I and Phase Ib (MAD):
1. Hypersensitivity or other clinically significant reaction to the study drug or its active ingredients.
2. Current treatment or use of any prescription medication within 14 days prior to admission to the clinic on Day -1 of active seasonal and perennial allergic rhinitis, non-allergic rhinitis, rhinosinusitis, or asthma. This includes antihistamines, asthma preventers and relievers, nasal decongestants, IN corticosteroids, and immunotherapy or use of over-the-counter medication/vitamins/supplements within 7 days prior to the first dose of study drug. Exceptions include contraception, paracetamol and standard doses of multivitamins.
3. Any clinically relevant structural nasal abnormalities, i.e., nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds, upper respiratory tract infection within 2 weeks prior to screening or first dose administration.
4. History of recurrent migraine headaches within 4 weeks prior to screening.
5. Positive alcohol breath, urine test, HBsAg, HepC virus antibody, or HIV antibody tests.
6. Participant has donated blood or blood products within 3 months prior to first dose administration.
7. Use of tobacco products or nicotine-containing products (including smoking cessation aids such as gum or patches.
8. Participant plans to travel to an area with known environmental ragweed exposures at any time during study participation.
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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
Recruiting
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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
4/07/2023
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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
1/11/2024
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Actual
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Sample size
Target
68
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
0
0
Nucleus Network Pty Ltd - Melbourne
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Recruitment postcode(s) [1]
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0
3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Inimmune Corporation
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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0
Avance Clinical Pty Ltd.
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses. This study will be conducted in two parts: Phase I single ascending dose (SAD) and Phase Ib multiple ascending dose (MAD).
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Trial website
https://clinicaltrials.gov/study/NCT06038279
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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
JonL. Ruckle
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Address
0
0
Inimmune Corp
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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
Tim Porter
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Address
0
0
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Country
0
0
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Phone
0
0
+61 450992172
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Fax
0
0
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Email
0
0
[email protected]
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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/NCT06038279