Study of LW231 in Participants With Chronic Hepatitis B

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Chronic HBV Infection

In brief

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.

Key facts

Study ID

NCT07179575

Run by

Shanghai Longwood Biopharmaceuticals Co., Ltd.

People needed

270

Starts

2025-10-01

Expected to finish

2027-11-01

Last updated by the study team

2025-10-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China

Full record on ClinicalTrials.gov

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