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

Treatment groups

See each treatment group below.

Sponsors and collaborators

Shanghai Longwood Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov