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NCT06384131Not yet recruiting

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection

A Randomized, Blinded, Placebo-Controlled Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection
Assembly BiosciencesPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Hepatitis B
Drug/Device/Intervention
ABI-4334
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Assembly Biosciences
Timeline & enrollment
Phase
Phase 1
Start date
Apr 30, 2024
End date
Apr 22, 2025
Enrollment
50 participants
Primary outcome

Primary Outcome Measure

Summary

This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety,
 PK, and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis
 B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The
 study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50
 subjects, randomized 8:2 to receive ABI-4334 or placebo.

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
NCT06384131
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06384131 through Pure Global AI's free database. This Phase 1 trial is sponsored by Assembly Biosciences and is currently Not yet recruiting. The study focuses on Chronic Hepatitis B. Target enrollment is 50 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.