NCT05542979

A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection

A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple-dose HH-003 Injection in Treatment Naïve Participants With HBeAg-positive Chronic HBV Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Huahui Health · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, multiple-ascending dose phase Ib study of HH-003 injection, which is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the safety, tolerability and pharmacokinetics of HH-003 injection in treatment-naive participants chronically infected with hepatitis B virus.

Conditions

• Chronic HBV Infection

Interventions

Type	Name	Description
DRUG	HH-003 injection	HH-003 injection is administrated via I.V. infusion
DRUG	Placebo	Placebo is administrated via I.V. infusion

Timeline

• Start date: 2019-08-05
• Primary completion: 2022-03-15
• Completion: 2022-03-15
• First posted: 2022-09-16
• Last updated: 2022-09-16

Locations

11 sites across 1 country: China