NCT04271592

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

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose Escalation and Food Effect Study of ABI-H3733 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Assembly Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	ABI-H3733 Liquid Oral Dosage Form	ABI-H3733 liquid oral dosage form
DRUG	ABI-H3733 Solid Oral Dosage Form	ABI-H3733 solid oral dosage form
DRUG	Placebo to ABI-H3733 Liquid Oral Dosage Form	Placebo to ABI-H3733 liquid oral dosage form
DRUG	Placebo to ABI-H3733 Solid Oral Dosage Form	Placebo to ABI-H3733 solid oral dosage form

Timeline

• Start date: 2020-05-17
• Primary completion: 2020-11-03
• Completion: 2021-01-14
• First posted: 2020-02-17
• Last updated: 2021-01-27

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study