NCT07183306

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

A Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HT-101 Injection and/or HT-102 Injection in Patients With Chronic Hepatitis B Virus Infection

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Suzhou HepaThera Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	HT-101	HT-101 given by subcutaneous injection.
DRUG	HT-102	HT-102 given by subcutaneous injection.

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-08-24
• Completion: 2027-05-03
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

7 sites across 1 country: China