NCT05298332

Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects

A Phase 1, Open-Label, 3-Cohort, Parallel, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose ATI-2173 50 mg in Healthy Japanese, Chinese, and Non-Asian Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Antios Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This is a single center, open-label, 3-Cohort, parallel, single-dose, study to evaluate the PK, safety, and tolerability of ATI-2173 50 mg administered orally in Japanese, Chinese, and Non-Asian healthy subjects incorporating a food effect analysis in Non-Asian healthy subjects.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	ATI-2173 50 mg	ATI-2173 is a phosphoramidate prodrug of the oral, non-chain terminating nucleoside analog clevudine being developed by Antios Therapeutics, Inc. for treatment of men and women with chronic hepatitis B (CHB)

Timeline

• Start date: 2022-03-29
• Primary completion: 2022-08-22
• Completion: 2022-08-22
• First posted: 2022-03-28
• Last updated: 2022-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study