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

Last updated: July 18, 2025
Sponsor: Assembly Biosciences
Overall Status: Completed

Phase

1

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

Placebo

ABI-4334

Clinical Study ID

NCT06384131
ABI-4334-102
2024-511051-18
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Body mass index (BMI) ≥ 18.0 and < 35.0 kg/m(2), where BMI = weight (kg)/(height [m])(2) with a minimum body weight of 45 kg

  2. Chronic hepatitis B infection, defined as HBV infection for ≥ 6 months documented

  3. Treatment-naïve or off-antiviral therapy for ≥ 24 weeks prior to Screening

  4. Lack of bridging fibrosis or cirrhosis

Exclusion

Exclusion Criteria:

  1. Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV),hepatitis D virus (HDV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV)

  2. History of liver transplant or evidence of advanced liver disease, cirrhosis, orhepatic decompensation

  3. Clinically significant diseases or conditions

  4. History of hepatocellular carcinoma

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
June 04, 2024
Estimated Completion Date:
May 14, 2025

Connect with a study center

  • ARENSIA Exploratory Medicine Cluj-Napoca

    Sofia,
    Bulgaria

    Site Not Available

  • ARENSIA Exploratory Medicine Chisinau

    Chisinau,
    Moldova, Republic of

    Site Not Available

  • New Zealand Clinical Research

    Auckland,
    New Zealand

    Site Not Available

  • ARENSIA Exploratory Medicine S.R.L.

    Bucharest,
    Romania

    Site Not Available

  • ARENSIA Exploratory Medicine SRL

    Cluj-Napoca,
    Romania

    Site Not Available

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