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

Recruiting Phase 1 Phase 2 Interventional Study
Ulcerative Colitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Accro Bioscience (Suzhou) Limited · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Diagnosis of Ulcerative Colitis (UC) or suspected UC symptom for at least 3 months prior to enrolment and confirmed diagnosis of UC by endoscopic and histopathological examinations during screening. * Evidence of active UC defined by modified Mayo score of 5 to 9 points (inclu…
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