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

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

Recruiting
18-65 years
All
Phase 1

Overview

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.

Eligibility

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.

Study details
    Hepatitis B
    Hepatitis B
    chronic hepatitis b

NCT04271592

Assembly Biosciences

16 February 2024

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