Study of LW231 in Participants With Chronic Hepatitis B

NCT07179575 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Longwood Biopharmaceuticals Co., Ltd.

Phase

Phase 1/2

Started

2025-11-11

Last updated

2026-08-26

Condition(s) studied

Chronic HBV Infection

Investigational drug(s) / intervention(s)

LW231LW231 placebo

LW231: LW231 tablets

LW231 placebo: LW231 placebo tablets

Study summary

This is a Phase Ib/II, multicenter, randomized, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of LW231 in participants with chronic hepatitis B virus (HBV) infection. The trial will include multiple-dose regimens of LW231 and assess LW231 in combination with NUCs.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: * Part 1: treatment-naïve and currently not treated subjects: LLOQ\<HBV DNA≤20000 IU/ml; 100 IU/mL\<HBsAg\<10000 IU/ml * Part 2: HBV DNA\<LLOQ or \< 20 IU/mL at screening; 100 IU/mL\<HBsAg\<3000 IU/mL Exclusion Criteria: * Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology. * History or current evidence of cirrhosis. * ALT or AST\>3×ULN; TBil\>1.3×ULN or DBil\>1.3×ULN; INR\>1.3×ULN

Primary outcome measure(s)

Change from baseline in HBV DNA Viral Load Assay — 4 weeks

Trial sites (2)

Facility	City	Region	Status
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	China	Not Yet Recruiting

More Shanghai Longwood Biopharmaceuticals Co., Ltd. trials in China

Evaluation of the Efficacy and Safety of Oral LW402 Tablets for the Treatment of Patients With Moderate-to-Severe Atopic Dermatitis Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07179575 on ClinicalTrials.gov ↗ ← All trials in China