drugset / Trial / NCT04271592

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

NCT04271592 ↗

Phase 1 Completed 120 enrolled Assembly Biosciences
RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start
2020-05-17
Primary completion
2020-11-03
Completion
2021-01-14

Drugs

EvaluationDrugModalityDoseRoute
Subject ABI-H3733 Unknown 100 mg Oral