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NCT Number: NCT05414981

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 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-H3733 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-H3733 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

Diagnostic Consultative Center Aleksandrovska, Sofia, Sofia-Grad, Bulgaria

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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
  • Current or prior treatment for cHBV

Treatment and study plan

ABI-H3733

Drug

25 mg or 100 mg tablets for oral administration

Placebo

Drug

25 mg or 100 mg tablets for oral administration

Primary outcomes

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

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

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

  2. Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

  3. Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

  4. Time to Maximum Plasma Concentration (Tmax) of ABI-H3733 in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

  5. Elimination half-life (t1/2) of ABI-H3733 in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

  6. To evaluate the effect of food on Cmax of ABI-H3733 in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

  7. To evaluate the effect of food on AUC of ABI-H3733 in subjects with cHBV

    Time frame: Through treatment period, up to 28 days

  8. To evaluate the effect of food on the proportion of subjects with AEs, premature discontinuation due to AEs and abnormal laboratory results

    Time frame: Through treatment period, up to 28 days

  9. To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV by Quantitative PCR

    Time frame: Through treatment period, up to 28 days

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-H3733 in Subjects With Chronic Hepatitis B Virus Infection

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2022
Registry last updated
Jun 29, 2023

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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