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NCT06311734Recruitment Completed

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
Shanghai Longwood Biopharmaceuticals Co., Ltd.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Hepatitis B
Drug/Device/Intervention
LW231 tablets
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shanghai Longwood Biopharmaceuticals Co., Ltd.
Location
Changchun, China
Timeline & enrollment
Phase
Phase 1
Start date
Nov 01, 2021
End date
May 01, 2024
Enrollment
100 participants
Primary outcome

Number of Participants With Adverse Events (AEs)

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 .

ICD-10 classifications
Acute hepatitis BChronic viral hepatitis B without delta-agentAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agent : other and unspecified phaseChronic viral hepatitis B without delta-agent : immune-tolerant phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06311734
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06311734 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shanghai Longwood Biopharmaceuticals Co., Ltd. and is currently Recruitment Completed. The study focuses on Chronic Hepatitis B. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.