Phase II Study to Assess Safety and Effectiveness of HRS-5635 Injection Alone or with Other Medicines in Adults Treated for Chronic Hepatitis B

What this Trial Is About

Researchers are evaluating the safety and effectiveness of HRS-5635 injection alone or combined with other treatments in adults with chronic hepatitis B who are already receiving therapy. This Phase II, multicenter, randomized, open-label study aims to better understand how these treatments affect the hepatitis B surface antigen levels in patients with this long-term liver infection. Participants will receive one of several doses of HRS-5635 injection given by subcutaneous injection, either alone or combined with Peg-IFN-, another injected medication. The study includes multiple groups to compare different doses and combinations, with a follow-up period extending up to 72 weeks to monitor changes in virus markers and treatment response. During the study, participants will have regular blood tests to measure hepatitis B surface antigen and other viral markers at specified intervals, including weeks 12, 48, and up to 72. Researchers will also watch for any safety concerns, drug resistance, or changes in viral activity. The total time involved varies depending on the treatment group but includes long-term monitoring of virus levels and treatment effects.

A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B