A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection

  • STATUS
    Recruiting
  • End date
    Jan 3, 2023
  • participants needed
    50
  • sponsor
    Assembly Biosciences
Updated on 3 July 2022
body mass index
hepatitis
cirrhosis
antiviral therapy

Summary

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.

Details
Condition Chronic Hepatitis B
Treatment Placebo, ABI-H3733
Clinical Study IdentifierNCT05414981
SponsorAssembly Biosciences
Last Modified on3 July 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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