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NCT Number: NCT06384131

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ARENSIA Exploratory Medicine Chisinau, Chisinau, Moldova

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Chronic hepatitis B infection, defined as HBV infection for ≥ 6 months documented
  • Treatment-naïve or off-antiviral therapy for ≥ 24 weeks prior to Screening
  • Lack of bridging fibrosis or cirrhosis

Exclusion criteria

  • 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)
  • History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
  • Clinically significant diseases or conditions
  • History of hepatocellular carcinoma

Treatment and study plan

ABI-4334

Drug

10 mg or 50 mg tablets for oral administration

Placebo

Drug

10 mg or 50 mg tablets for oral administration

Primary outcomes

  1. To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses

    Time frame: Through end of study, up to 56 days

    Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results

Secondary outcomes

  1. To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

    Noncompartmental plasma PK parameters

  2. Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334

    Time frame: Through treatment period, up to 28 days

    Mean change in log10 HBV DNA between Baseline and Day 28

  3. To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

    Area Under Plasma Concentration-Time Curve (AUC) of ABI-4334 in subjects with cHBV

  4. To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

    Time to Maximum Plasma Concentration (Tmax) of ABI-4334 in subjects with cHBV

  5. Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

  6. Changes in HBV pregenomic ribonucleic acid (pgRNA) and additional markers of antiviral activity in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

    To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV

  7. Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334

    Time frame: Through treatment period, up to 28 days

    Proportion of subjects with HBV DNA < lower limit of quantification (LLOQ) and/or limit of detection (LOD)

  8. Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334

    Time frame: Through treatment period, up to 28 days

    Mean time elapsed to subjects achieving HBV DNA < LLOQ and/or LOD

Sponsors and collaborators

Lead sponsor

Assembly Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2024
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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