Study of LW231 in Participants With Chronic Hepatitis B

Phase 2RecruitingNCT07179575

Shanghai Longwood Biopharmaceuticals Co., Ltd.270 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

270

Conditions

Chronic HBV Infection

Interventions

LW231DRUG

LW231 tablets

LW231 placeboDRUG

LW231 placebo tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Change from baseline in HBV DNA Viral Load Assay

Time frame: 4 weeks

Secondary Outcomes

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

Change from baseline in HBsAg

Time frame: Up to 28 weeks

Maximum Plasma Concentration (Cmax) of LW231

Time frame: Up to 28 Weeks

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

Time frame: Up to 28 weeks

Data from ClinicalTrials.gov

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