A Study to Assess Safety Tolerability and Pharmacokinetics of ABI-H3733 in Healthy Adults

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Assembly Biosciences
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Updated on 16 February 2024
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Summary

This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1 includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation. Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2 of the study to explore additional dose levels, solid oral dosage formulations, or for cohort expansion.

Details
Condition Hepatitis B, Hepatitis B, chronic hepatitis b
Age 18years - 65years
Treatment ABI-H3733 Liquid Oral Dosage Form, ABI-H3733 Solid Oral Dosage Form, Placebo to ABI-H3733 Liquid Oral Dosage Form, Placebo to ABI-H3733 Solid Oral Dosage Form
Clinical Study IdentifierNCT04271592
SponsorAssembly Biosciences
Last Modified on16 February 2024

Eligibility

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Inclusion Criteria

No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening

Exclusion Criteria

Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C
History of or current persistent drug or alcohol abuse
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