NCT05116865

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled HH-120 Aerosol in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Huahui Health · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Approximately 48 participants will be sequentially enrolled into either 1 of 3 SAD cohorts (n=8 per cohort), or 1 of 3 MAD cohorts (n= 8 per cohort). An adaptive dose escalation schedule will be employed for both SAD and MAD parts of the study.

Conditions

• COVID-19 Respiratory Infection

Interventions

Type	Name	Description
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	Placebo to match

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-05-26
• Completion: 2022-08-02
• First posted: 2021-11-11
• Last updated: 2023-09-26

Locations

1 site across 1 country: Australia