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)
1 other identifier
interventional
270
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2025
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2025
CompletedFirst Posted
Study publicly available on registry
September 18, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
October 2, 2025
September 1, 2025
1.4 years
September 16, 2025
September 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in HBV DNA Viral Load Assay
4 weeks
Secondary Outcomes (4)
Number of Participants With Adverse Events (AEs)
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
Study Arms (6)
Part1: LW231 Dose 1
EXPERIMENTALLW231 Dose Escalation Cohort 1, administered orally, QD
Part1: LW231 Dose 2
EXPERIMENTALLW231 Dose Escalation Cohort 2, administered orally, BID
Part1: LW231 Dose 3
EXPERIMENTALLW231 Dose Escalation Cohort 2, administered orally, QD
Part2: LW231 treatment group 1
EXPERIMENTALLW231 administered orally, BID + NUCs
Part2: LW231 treatment group 2
EXPERIMENTALLW231 administered orally, QD +NUCs
Part2: LW231 placebo group
PLACEBO COMPARATORLW231 placebo + NUCs
Interventions
LW231 tablets
LW231 placebo tablets
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2025
First Posted
September 18, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share