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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05116865
Registration number
NCT05116865
Ethics application status
Date submitted
19/10/2021
Date registered
11/11/2021
Date last updated
26/09/2023
Titles & IDs
Public title
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled HH-120 Aerosol in Healthy Volunteers
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Scientific title
A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of Inhaled HH-120 Aerosol in Healthy Volunteers
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Secondary ID [1]
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HH120-101
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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:
COVID-19 Respiratory Infection
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - HH-120 Dose 1
Other interventions - HH-120 Dose 2
Other interventions - HH-120 Dose 3
Treatment: Drugs - Placebo
Experimental: Single Ascending Dose Cohort A1 - Subjects will receive a single dose of either dose level 1 of HH-120 or placebo
Experimental: Single Ascending Dose Cohort A2 - Subjects will receive a single dose of either dose level 2 of HH-120 or placebo
Experimental: Single Ascending Dose Cohort A3 - Subjects will receive a single dose of either dose level 3 of HH-120 or placebo
Experimental: Multiple Ascending Doses Cohort B1 - Subjects will receive multiple doses of either Dose level 1of HH-120 or placebo
Experimental: Multiple Ascending Doses Cohort B2 - Subjects will receive multiple doses of either Dose level 2 of HH-120 or placebo
Experimental: Multiple Ascending Doses Cohort B3 - Subjects will receive multiple doses of either Dose level 3 of HH-120 or placebo
Other interventions: HH-120 Dose 1
Dose level 1 of HH-120
Other interventions: HH-120 Dose 2
Dose level 2 of HH-120
Other interventions: HH-120 Dose 3
Dose level 3 of HH-120
Treatment: Drugs: Placebo
Placebo to match
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Intervention code [1]
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Other interventions
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Intervention code [2]
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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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Number of participants with treatment emergent adverse events (TEAEs)
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Assessment method [1]
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An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.
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Timepoint [1]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Primary outcome [2]
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Severity of treatment emergent adverse events (TEAEs)as assessed by CTCAE v5.0
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Assessment method [2]
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An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.
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Timepoint [2]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Primary outcome [3]
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Duration of treatment emergent adverse events (TEAEs)
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Assessment method [3]
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An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.
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Timepoint [3]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Primary outcome [4]
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Number of participants with serious adverse events (SAEs)
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Assessment method [4]
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A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect
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Timepoint [4]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Primary outcome [5]
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Severity of serious adverse events (SAEs) as assessed by CTCAE v5.0
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Assessment method [5]
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A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect
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Timepoint [5]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Primary outcome [6]
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Duration of serious adverse events (SAEs)
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Assessment method [6]
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A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect
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Timepoint [6]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Primary outcome [7]
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Number of participants with abnormal clinically significant physical examination findings
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Assessment method [7]
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Complete and symptom directed physical examination will be performed
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Timepoint [7]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Primary outcome [8]
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Number of participants with abnormal clinically significant electrocardiogram (ECG)
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Assessment method [8]
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Single resting 12- lead ECGs will be collected
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Timepoint [8]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Primary outcome [9]
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Number of participants with clinically significant change in vital signs from baseline
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Assessment method [9]
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Vital signs include heart rate, blood pressure, respiratory rate and tympanic temperature
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Timepoint [9]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Primary outcome [10]
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Changes in the spirometry score from Baseline
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Assessment method [10]
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Measured by Forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) after dosing
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Timepoint [10]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Primary outcome [11]
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Number of participants with abnormal clinically significant clinical laboratory parameters
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Assessment method [11]
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Clinical laboratory test include hematology, coagulation, biochemistry and urinalysis
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Timepoint [11]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Secondary outcome [1]
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Cmax in SAD and MAD
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Assessment method [1]
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Maximum observed HH-120 concentration
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Timepoint [1]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Secondary outcome [2]
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Tmax in SAD and MAD
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Assessment method [2]
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Time to the maximum observed HH-120 concentration
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Timepoint [2]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Secondary outcome [3]
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t1/2 in SAD and MAD part
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Assessment method [3]
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Terminal elimination half life calculated as ln (2)/?z
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Timepoint [3]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Secondary outcome [4]
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AUC0-last
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Assessment method [4]
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Area under the plasma concentration-time curve from time zero (from the start of inhalation time) to the last time point with measurable analyte concentration
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Timepoint [4]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Secondary outcome [5]
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AUC0-inf
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Assessment method [5]
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AUC from time zero (from the start of inhalation time) extrapolated to infinity
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Timepoint [5]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Secondary outcome [6]
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%AUCextrap
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Assessment method [6]
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The percentage of the AUC that has been extrapolated beyond the last observed data point
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Timepoint [6]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Secondary outcome [7]
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Kel or ?z
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Assessment method [7]
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Apparent terminal elimination rate constant, calculated by linear regression of the terminal linear portion of the log concentration vs time curve
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Timepoint [7]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Secondary outcome [8]
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CL/F
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Assessment method [8]
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Apparent total body clearance
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Timepoint [8]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Secondary outcome [9]
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Vz/F in SAD
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Assessment method [9]
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Apparent volume of distribution during the terminal phase
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Timepoint [9]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Secondary outcome [10]
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CL/Fss in MAD
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Assessment method [10]
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Apparent total plasma clearance at steady state
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Timepoint [10]
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Day 1-Day 22
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Secondary outcome [11]
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Vz/Fss in MAD
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Assessment method [11]
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Apparent terminal volume of distribution at steady state
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Timepoint [11]
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Day1- Day 22
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Secondary outcome [12]
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Accumulation ratio (RA)
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Assessment method [12]
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AUC0-24 hours on Day 7/AUC0-24 hours on Day 1
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Timepoint [12]
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Day 1- Day 7
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Secondary outcome [13]
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Immunogenicity of HH-120
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Assessment method [13]
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To determine the presence and levels of anti-drug antibody (ADA).
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Timepoint [13]
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Day 1- Day 15 (SAD) or Day 22 (MAD)
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Eligibility
Key inclusion criteria
1. Healthy male or female volunteers aged 18 to 65 years (both inclusive)
2. Participants must have a body mass index between = 18.0 and = 32 .0 kg/m2 and a
bodyweight of at least 45 kg at Screening.
3. Participants must be a non-smoker and must not have used any tobacco products within
90 days prior to Screening.
4. Participants must be in good general health, with no significant medical history, have
no clinically significant abnormalities on physical examination at screening and/or
before administration of the initial dose of IP.
5. Participants must have clinical laboratory values within normal range.
6. Females must be non-pregnant and non-lactating, and must use an acceptable, highly
effective double contraception from Screening until study completion, including the
follow-up period.
7. Males must not donate sperm for at least 90 days after the last dose of IP.
8. Participants must have the ability and willingness to attend the necessary visits to
the CRU.
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Minimum age
18
Years
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Maximum age
65
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
1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at
any time during the study, including the follow-up period.
2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory
abnormality that, in the PI's (or delegate's) opinion, could adversely affect the
safety of the participant or that might interfere with the conduct of the study.
3. Presence of any underlying physical or psychological medical condition
4. Pre-existing severe obstructive disease of the respiratory system such as chronic
obstructive pulmonary disease or asthma , including resolved childhood asthma, which
may impact inhalation as judged by the PI, delegate, or Sponsor.
5. History or evidence o f any anatomical airway defect, which in the opinion of the PI,
may impact inhalation.
6. Abnormal spirometry findings at Screening that are considered by the PI to be
clinically significant, including FEV1 < 80% or FVC < 80%.
7. Blood donation of > 500 mL or significant blood loss within 60 days prior to the first
IP administration or plasma donation within 7 days prior to IP administration.
8. Systemic or respiratory infection within 2 weeks before the Screening visit or fever
(tympanic temperature > 37.5°C) or symptomatic viral or bacterial infection at time of
Screening.
9. Current infection with SARS-CoV-2, infection within the 2 weeks prior to Screening, or
a history of SARS-CoV-2 infection plus symptoms of post-COVID syndrome.
10. History of anaphylaxis or other significant allergy in the opinion of the PI or known
allergy or hypersensitivity to any of the components of the IP.
11. History of malignancy, except for non-melanoma skin cancer, excised more than 2 years
ago and cervical intraepithelial neoplasia that has been successfully cured more than
5 years prior to Screening.
12. A personal history of unexplained blackouts or fainting or known risk factors for
Torsade de Pointes (eg, hypokalemia, heart failure).
13. Abnormal 12-lead ECG findings at Screening that are considered by the PI to be
clinically significant, including arrhythmias or marked QT interval abnormalities
(QTcF < 300 msec or = 450 msec at Screening).
14. Confirmed (eg, 2 consecutive triplicate measurements) average systolic blood pressure
(SBP) > 140 or < 90 mmHg, and diastolic blood pressure (DBP) > 90 or < 45 mmHg at
Screening.
15. Confirmed (eg, 2 consecutive triplicate measurements) average resting HR > 100 or < 45
beats per minute at Screening.
16. Vaccination with a live vaccine within the 4 weeks prior to Screening or that is
planned within 4 weeks of dosing, and any non-live vaccination within the 2 weeks
prior to Screening, or that is planned within 2 weeks of dosing or planned during
study participation (including vaccines for COVID-19).
17. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or
human immunodeficiency virus (HIV) antibody at Screening.
18. Participants with a positive toxicology screening panel (urine test including
qualitative identification of barbiturates, tetrahydrocannabinol [THC], amphetamines,
benzodiazepines, opiates, cocaine, and cotinine), or alcohol breath test at Screening
or Day -1.
19. Participants with a history of substance abuse or dependency or history of
recreational intravenous (IV) drug use over the last 6 months (by self-declaration).
20. Use of any IP or medical device within 30 days prior to screening.
21. Use of any prescription drugs for 14 days prior to dosing or over the counter
medication, herbal remedies, supplements or vitamins 7 days prior to dosing.
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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 analysing the results/data
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Intervention assignment
Other
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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
Completed
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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
1/11/2021
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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
2/08/2022
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Sample size
Target
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Accrual to date
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Final
52
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Nucleus Network - Brisbane
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Recruitment postcode(s) [1]
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- Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Huahui Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 1, randomized, double-blinded, placebo controlled, dose escalation study of
HH-120 in healthy adult volunteers. HH-120 is a novel inhalable biologic being developed for
COVID-19 treatment. The study aims to evaluate the safety, tolerability and pharmacokinetic
profile of HH-120 administered by aerosol inhalation after single and multiple ascending
doses.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05116865
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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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Yongqing Lin
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Address
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Huahui Health Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05116865
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