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

An Open-label Phase IIa Study to Evaluate the Antiviral Effect and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and D Co-infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Huahui Health · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B and Hepatitis D Co-infection

Interventions

Type	Name	Description
BIOLOGICAL	HH-003 20mg/kg	HH-003 20mg/kg Q2W intravenously for 24 weeks
BIOLOGICAL	HH-003 3mg/kg	HH-003 3mg/kg Q2W intravenously for 24 weeks

Timeline

• Start date: 2021-08-11
• Primary completion: 2022-07-25
• Completion: 2023-01-04
• First posted: 2023-01-06
• Last updated: 2023-10-10

Locations

1 site across 1 country: China