NCT05275465

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers

A Randomized, Placebo-controlled, Single-Ascending Dose Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Huahui Health · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Huahui Health is developing a treatment for Hepatitis B virus. This study is designed to evaluate the safety and tolerability of HH-006, a hepatitis virus neutralizing monoclonal antibody in healthy volunteers, and to determine its pharmacokinetic profile and immunogenicity.

Detailed description

This is a double-blind, placebo-controlled, Phase Ia study aimed to evaluate the safety and tolerability of HH-006 after single ascending doses given as subcutaneous injections.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	HH-006	Different dose levels of HH-006
DRUG	Placebo	Different dose levels of placebo

Timeline

• Start date: 2022-05-03
• Primary completion: 2022-12-29
• Completion: 2022-12-29
• First posted: 2022-03-11
• Last updated: 2023-04-07

Locations

1 site across 1 country: Australia