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RECRUITING
NCT07083193
PHASE1/PHASE2

A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis

Sponsor: Accro Bioscience (Suzhou) Limited

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-01-20

Completion Date

2027-04-30

Last Updated

2025-07-24

Healthy Volunteers

No

Interventions

DRUG

AC-101

AC-101 tablets will be administered orally.

Locations (1)

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China