Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-31 @ 9:25 PM
Study NCT ID:
NCT07083193
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis
Sponsor:
Accro Bioscience (Suzhou) Limited
Organization:
Study Overview
Official Title:
A Phase 1b, Multicenter, Open-label, Randomized Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis
Status:
RECRUITING
Status Verified Date:
2025-07
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:
The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of AC-101 tablets in participants with moderate-to-severe ulcerative colitis.
The total study duration is up to 17 weeks, including 4-week screening, 12-week treatment period, and 1-week safety follow-up.
The study will enroll approximately 24 participants with moderate to severe active ulcerative colitis.
The total study duration is up to 17 weeks, including 4-week screening, 12-week treatment period, and 1-week safety follow-up.
The study will enroll approximately 24 participants with moderate to severe active ulcerative colitis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: