NCT06425341

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 369 (estimated)
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Chronic Hepatitis B

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-06
• Primary completion: 2026-08-30
• Completion: 2027-01-19
• First posted: 2024-05-22
• Last updated: 2025-11-17

Locations

1 site across 1 country: China