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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • LW231

    Drug

    LW231 tablets

  • LW231 placebo

    Drug

    LW231 placebo tablets

Treatment groups

270 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part1: LW231 Dose 1Experimental treatment 2 interventions
Group B: Part1: LW231 Dose 2Experimental treatment 2 interventions
Group C: Part1: LW231 Dose 3Experimental treatment 2 interventions
Group D: Part2: LW231 treatment group 1Experimental treatment 1 intervention
Group E: Part2: LW231 treatment group 2Experimental treatment 1 intervention
Group F: Part2: LW231 placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in HBV DNA Viral Load Assay

Time frame
4 weeks

Secondary outcomes

1

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.

Time frame
up to 28 weeks
2

Change from baseline in HBsAg

Time frame
Up to 28 weeks
3

Maximum Plasma Concentration (Cmax) of LW231

Time frame
Up to 28 Weeks
4

Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231

Time frame
Up to 28 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Longwood Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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