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RECRUITING
NCT06425341
PHASE2

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

Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

369

Start Date

2024-06-06

Completion Date

2027-01-19

Last Updated

2025-11-17

Healthy Volunteers

No

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

Locations (1)

Nanfang Hospital

Guangzhou, Guangdong, China