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

PHASE2RecruitingINTERVENTIONAL
Enrollment

303

Participants

Timeline

Start Date

June 6, 2024

Primary Completion Date

August 30, 2026

Study Completion Date

January 19, 2027

Conditions
Chronic Hepatitis B
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

Trial Locations (1)

510515

RECRUITING

Nanfang Hospital, Guangzhou

All Listed Sponsors
lead

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY