Study of LW231 in Participants With Chronic Hepatitis B

Shanghai Longwood Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Chronic HBV Infection

Treatments: Drug: LW231; Drug: LW231 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07179575

LW231-Ib/II-01

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 6 patient groups, including a placebo group

Part1: LW231 Dose 1

Experimental group

Description:

LW231 Dose Escalation Cohort 1, administered orally, QD

Treatment:

Drug: LW231 placebo

Drug: LW231

Part1: LW231 Dose 2

Experimental group

Description:

LW231 Dose Escalation Cohort 2, administered orally, BID

Treatment:

Drug: LW231 placebo

Drug: LW231

Part1: LW231 Dose 3

Experimental group

Description:

LW231 Dose Escalation Cohort 2, administered orally, QD

Treatment:

Drug: LW231 placebo

Drug: LW231

Part2: LW231 treatment group 1

Experimental group

Description:

LW231 administered orally, BID + NUCs

Treatment:

Drug: LW231

Part2: LW231 treatment group 2

Experimental group

Description:

LW231 administered orally, QD +NUCs

Treatment:

Drug: LW231

Part2: LW231 placebo group

Placebo Comparator group

Description:

LW231 placebo + NUCs

Treatment:

Drug: LW231 placebo