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A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection - Trial NCT06384131

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.

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NCT06384131
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06384131
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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

Study Focus

Chronic Hepatitis B

ABI-4334

Interventional

drug

Sponsor & Location

Assembly Biosciences

Timeline & Enrollment

Phase 1

Apr 30, 2024

Apr 22, 2025

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-naรฏve 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 B
Chronic viral hepatitis B without delta-agent
Acute delta-(super)infection in chronic hepatitis B
Chronic viral hepatitis B without delta-agent : other and unspecified phase
Chronic viral hepatitis B without delta-agent : immune-tolerant phase

Data Source

ClinicalTrials.gov

NCT06384131

Non-Device Trial