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NCT Number: NCT07179575

Study of LW231 in Participants With Chronic Hepatitis B

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.

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Key information

Conditions

Chronic HBV Infection

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LW231

Drug

LW231 tablets

LW231 placebo

Drug

LW231 placebo tablets

Primary outcomes

  1. Change from baseline in HBV DNA Viral Load Assay

    Time frame: 4 weeks

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: up to 28 weeks

    An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product (including investigational drug) during the course of a clinical investigation. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease that was temporally associated with the use of the investigational product, regardless of whether it was considered to be related to the investigational product or not.

  2. Change from baseline in HBsAg

    Time frame: Up to 28 weeks

  3. Maximum Plasma Concentration (Cmax) of LW231

    Time frame: Up to 28 Weeks

  4. Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231

    Time frame: Up to 28 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Longwood Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

Phase Ib/II Study of LW231 in Patients With Chronic Hepatitis B: Evaluation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy With Multiple-Dose, Dose-Escalation, and Combination With Nucleos(t)Ide Analogs (NUC)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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