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RECRUITING
NCT07606950
PHASE3

Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks),NAs-only treatment stage(12 weeks) and the off-treatment follow-up (24 weeks), is up to approximately 100 weeks at maximum for each participant.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS-5635 Injection in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

540

Start Date

2026-07-17

Completion Date

2028-06

Last Updated

2026-07-24

Healthy Volunteers

No

Interventions

DRUG

HRS-5635 Injection

HRS-5635 Injection, administered by subcutaneous injection;

DRUG

Placebo

Placebo, administered by subcutaneous injection.

Locations (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangzhou, China