NCT07245953

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

A Clinical Study to Evaluate the Efficacy and Safety of HT-101 Injection Combined With HT-102 Injection in Patients With Chronic Hepatitis B

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Suzhou HepaThera Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is A multicenter, randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HT-101 injection combined with HT-102 injection in patients with chronic hepatitis B. It consists of two phases: the main trial and the extension period. The main trial phase aims to explore the efficacy of different courses of HT-101 injection combined with HT-102 injection in treating patients with chronic hepatitis B and evaluate the optimal treatment strategy. The extension period phase, based on the main trial, assesses the long-term safety and efficacy of HT-101 injection combined with HT-102 injection.

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
DRUG	HT-101 placebo	HT-101 placebo given by subcutaneous injection
DRUG	HT-102 placebo	HT-102 placebo given by subcutaneous injection

Timeline

• Start date: 2025-11-05
• Primary completion: 2027-02-01
• Completion: 2027-05-01
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

12 sites across 1 country: China