drugset
drugset / Trial / NCT05674448

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection

NCT05674448 ↗

Phase 2 Terminated 9 enrolled Huahui Health
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis B and hepatitis D co-infection. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV/HDV.

Timeline

Start
2021-08-11
Primary completion
2022-07-25
Completion
2023-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Libevitug Monoclonal antibody 3 mg/kg Intravenous
Subject Libevitug Monoclonal antibody 20 mg/kg Intravenous

Indications

chronic hepatitis B virus infection