Health Trials

Study of LW231 in Participants With Chronic Hepatitis B

ConditionChronic HBV Infection
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai Longwood Biopharmaceuticals Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • LW231
  • LW231 placebo

Treatment groups

270 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

2
The First Affiliated Hospital, Zhejiang University School of Medicine HangzhouZhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou China

Sponsors and collaborators

Shanghai Longwood Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov