Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT05298332
Status:
TERMINATED
Last Update Posted:
2022-11-18
First Post:
2022-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects
Sponsor:
Antios Therapeutics, Inc
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated by the Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: