A Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled HH-120 Aerosol in Healthy Volunteers
NCT05116865 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2023-09-26
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.
Conditions
- COVID-19 Respiratory Infection
Interventions
- BIOLOGICAL
-
HH-120 Dose 1
Dose level 1 of HH-120
- BIOLOGICAL
-
HH-120 Dose 2
Dose level 2 of HH-120
- BIOLOGICAL
-
HH-120 Dose 3
Dose level 3 of HH-120
- DRUG
-
Placebo to match
Sponsors & Collaborators
-
Huahui Health
lead INDUSTRY
Principal Investigators
-
Yongqing Lin · Huahui Health Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-11-01
- Primary Completion
- 2022-05-26
- Completion
- 2022-08-02
Countries
- Australia
Study Locations
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