Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT03220633
Status:
COMPLETED
Last Update Posted:
2017-07-18
First Post:
2015-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study To Assess Safety, Tolerability And PK Of ATB-346 In Healthy Subjects
Sponsor:
Antibe Therapeutics Inc.
Organization:
Study Overview
Official Title:
A Double-Blind, Placebo-Controlled, Phase I Study To Assess Safety, Tolerability And Pharmacokinetics Of Single/Multiple Ascending Doses Of ATB-346 Orally Administrated In Healthy Male And Female Subjects
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double-blind, placebo-controlled, phase I study to assess safety, tolerability and pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy male and female subjects.
Detailed Description:
Single ascending doses of ATB-346 given to multiple cohorts followed by multiple ascending doses of ATB-346 given to multiple cohorts in order to assess its safety, tolerability, and pharmacokinetics. A single dose cohort was also conducted to assess the effect of food on the drug's characteristics.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: