Study of LW231 in Participants With Chronic Hepatitis B

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic HBV Infection
• Intervention / Treatment: Drug: LW231; Drug: LW231 placebo

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Not yet recruiting
    • The First Affiliated Hospital, Zhejiang University School of Medicine
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Yunqing Qiu; Phone Number: +86 13588189339; Email: qiuyq@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part1: LW231 Dose 1; LW231 Dose Escalation Cohort 1, administered orally, QD	Drug: LW231; LW231 tablets; Drug: LW231 placebo; LW231 placebo tablets
Experimental: Part1: LW231 Dose 2; LW231 Dose Escalation Cohort 2, administered orally, BID	Drug: LW231; LW231 tablets; Drug: LW231 placebo; LW231 placebo tablets
Experimental: Part1: LW231 Dose 3; LW231 Dose Escalation Cohort 2, administered orally, QD	Drug: LW231; LW231 tablets; Drug: LW231 placebo; LW231 placebo tablets
Experimental: Part2: LW231 treatment group 1; LW231 administered orally, BID + NUCs	Drug: LW231; LW231 tablets
Experimental: Part2: LW231 treatment group 2; LW231 administered orally, QD +NUCs	Drug: LW231; LW231 tablets
Placebo Comparator: Part2: LW231 placebo group; LW231 placebo + NUCs	Drug: LW231 placebo; LW231 placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HBV DNA Viral Load Assay	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs)	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.	up to 28 weeks
Change from baseline in HBsAg		Up to 28 weeks
Maximum Plasma Concentration (Cmax) of LW231		Up to 28 Weeks
Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231		Up to 28 weeks

Collaborators and Investigators

• Sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: September 16, 2025
• First Submitted That Met QC Criteria: September 16, 2025
• First Posted (Estimated): September 18, 2025

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 28, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: LW231-Ib/II-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No