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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
HH120-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 Respiratory Infection 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - HH-120 Dose 1
Treatment: Other - HH-120 Dose 2
Treatment: Other - 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


Treatment: Other: HH-120 Dose 1
Dose level 1 of HH-120

Treatment: Other: HH-120 Dose 2
Dose level 2 of HH-120

Treatment: Other: HH-120 Dose 3
Dose level 3 of HH-120

Treatment: Drugs: Placebo
Placebo to match
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment emergent adverse events (TEAEs)
Timepoint [1] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Primary outcome [2] 0 0
Severity of treatment emergent adverse events (TEAEs)as assessed by CTCAE v5.0
Timepoint [2] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Primary outcome [3] 0 0
Duration of treatment emergent adverse events (TEAEs)
Timepoint [3] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Primary outcome [4] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [4] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Primary outcome [5] 0 0
Severity of serious adverse events (SAEs) as assessed by CTCAE v5.0
Timepoint [5] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Primary outcome [6] 0 0
Duration of serious adverse events (SAEs)
Timepoint [6] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Primary outcome [7] 0 0
Number of participants with abnormal clinically significant physical examination findings
Timepoint [7] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Primary outcome [8] 0 0
Number of participants with abnormal clinically significant electrocardiogram (ECG)
Timepoint [8] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Primary outcome [9] 0 0
Number of participants with clinically significant change in vital signs from baseline
Timepoint [9] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Primary outcome [10] 0 0
Changes in the spirometry score from Baseline
Timepoint [10] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Primary outcome [11] 0 0
Number of participants with abnormal clinically significant clinical laboratory parameters
Timepoint [11] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Secondary outcome [1] 0 0
Cmax in SAD and MAD
Timepoint [1] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Secondary outcome [2] 0 0
Tmax in SAD and MAD
Timepoint [2] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Secondary outcome [3] 0 0
t1/2 in SAD and MAD part
Timepoint [3] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Secondary outcome [4] 0 0
AUC0-last
Timepoint [4] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Secondary outcome [5] 0 0
AUC0-inf
Timepoint [5] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Secondary outcome [6] 0 0
%AUCextrap
Timepoint [6] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Secondary outcome [7] 0 0
Kel or ?z
Timepoint [7] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Secondary outcome [8] 0 0
CL/F
Timepoint [8] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Secondary outcome [9] 0 0
Vz/F in SAD
Timepoint [9] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)
Secondary outcome [10] 0 0
CL/Fss in MAD
Timepoint [10] 0 0
Day 1-Day 22
Secondary outcome [11] 0 0
Vz/Fss in MAD
Timepoint [11] 0 0
Day1- Day 22
Secondary outcome [12] 0 0
Accumulation ratio (RA)
Timepoint [12] 0 0
Day 1- Day 7
Secondary outcome [13] 0 0
Immunogenicity of HH-120
Timepoint [13] 0 0
Day 1- Day 15 (SAD) or Day 22 (MAD)

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2022
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Huahui Health
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05116865
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yongqing Lin
Address 0 0
Huahui Health Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05116865