Clinical Trial

A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection

Active, Not Recruiting Phase 1/2
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Summary
This study is A multicenter, open-label, partial multiple-ascending doses phase1b/2 in which participants with chronic hepatitis B virus (HBV) infection will receive HT-101 and/or HT-102 and be assessed for safety, tolerability, Pharmacokinetics, and Pharmacodynamics. Approximately 86 patients with chronic hepatitis B infection were planned to be recruited. Among them, Group A and Group AA received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks. Group B received HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks. Groups C, D, and E received HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks. During the study period, all subjects received nucleoside (acid) analogues (NAs) treatment.
Trial Details
NCT Number NCT07183306
Lead Sponsor Suzhou HepaThera Biotech Co., Ltd.
Conditions Chronic Hepatitis B
Enrollment 86 participants
Start Date 2024-12-30
Primary Completion 2026-08-24 (estimated)
Study Completion 2027-05-03 (estimated)
Updated on ClinicalTrials.gov 2025-09-19