Tests LW231 in adults with chronic hepatitis B
Tests LW231 in adults with chronic hepatitis B virus infection.
Plain-language title generated from the registry record
Registry title: Study of LW231 in Participants With Chronic Hepatitis B
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 60 with long-term (chronic) hepatitis B infection. It tests the safety and early effect of the study drug LW231, alone and with NUC medicines.
- Age
- 18 to 60 years
- Sex
- All sexes can join.
- Disease stage
- Chronic hepatitis B. Part 1: treatment-naïve and currently not treated, HBV DNA above LLOQ and up to 20000 IU/ml. Part 2: HBV DNA below LLOQ or below 20 IU/mL.
- Earlier treatment
- Part 1: people who have never been treated and are not treated now. Part 2: the record gives no prior-treatment rule.
- Biomarker or test result
- Part 1: HBsAg above 100 IU/mL and below 10000 IU/ml. Part 2: HBsAg above 100 IU/mL and below 3000 IU/mL.
Main reasons for not taking part
- Infection with hepatitis A, C, D, E or HIV
- Liver disease not caused by HBV
- Cirrhosis, now or in the past
- ALT or AST above 3×ULN
- TBil or DBil above 1.3×ULN, or INR above 1.3×ULN
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07179575, who can take part
Where in China
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Longwood Biopharmaceuticals Co., Ltd.
- Trial code
- NCT07179575
- Record updated
- 26 August 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology; ALT or AST>3×ULN; TBil>1.3×ULN or DBil>1.3×ULN; INR>1.3×ULN; History or current evidence of cirrhosis.