NCT06311734

A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection

A Single-center, Randomized, Double-blind,Placebo-controlled Study, to Evaluate Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of LW231 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .

Detailed description

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of LW231 tablets in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. In addition, the study will evaluate the initial antiviral efficacy of LW231 in CHB patients following a multiple dosing regimen.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	LW231 tablets	P.O.
DRUG	Placebo	P.O.

Timeline

• Start date: 2022-06-21
• Primary completion: 2024-01-01
• Completion: 2024-03-18
• First posted: 2024-03-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: China