drugset / Trial / NCT04271592
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ABI-H3733 | Unknown | 100 mg | Oral |