drugset / Trial / NCT05734807
A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. 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.
Timeline
- Start
- 2022-07-20
- Primary completion
- 2024-04-17
- Completion
- 2024-04-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Libevitug | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |