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
NCT06425341 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 369
Last updated 2025-11-17
Summary
A multicenter, randomized, open, parallel-designed Phase II 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.
Conditions
Interventions
- DRUG
-
HRS-5635 Injection
HRS-5635 Injection low dose administered by subcutaneous injection
- DRUG
-
HRS-5635 Injection
HRS-5635 Injection medium dose administered by subcutaneous injection
- DRUG
-
HRS-5635 Injection
HRS-5635 Injection high dose administered by subcutaneous injection
- DRUG
-
HRS-5635 Injection
HRS-5635 Injection lowest dose administered by subcutaneous injection
- DRUG
-
HRS-5635 Injection (low dose) and Peg-IFN-α
HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection
- DRUG
-
HRS-5635 Injection (high dose) and Peg-IFN-α
HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection
- DRUG
-
Peg-IFN-α
Peg-IFN-α, administered by subcutaneous injection
- DRUG
-
HRS-5635 Injection with Peg-IFN-α
HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection
- DRUG
-
HRS-5635 Injection
HRS-5635 Injection, administered by subcutaneous injection
Sponsors & Collaborators
-
Fujian Shengdi Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-06
- Primary Completion
- 2026-08-30
- Completion
- 2027-01-19
Countries
- China
Study Locations
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