RecruitingPhase 1Phase 2NCT07083193

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

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


Sponsor

Accro Bioscience (Suzhou) Limited

Enrollment

24 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new tablet called AC-101 for people with moderate to severe ulcerative colitis — a condition where the large intestine becomes chronically inflamed, causing frequent bloody diarrhea and cramping. Researchers want to see if this new medication can reduce inflammation and improve symptoms. **You may be eligible if...** - You have been diagnosed with ulcerative colitis for at least 3 months, confirmed by an internal camera exam (endoscopy) - Your disease is currently active and causing symptoms like rectal bleeding and frequent bowel movements - Your disease extends at least 15 cm inside the bowel - You have tried at least one conventional treatment that has not worked well enough **You may NOT be eligible if...** - You have had severe complications like a toxic colon or recent surgery for colitis - You have a current serious infection - You have recently used biologic medications or certain immunosuppressants - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAC-101

AC-101 tablets will be administered orally.


Locations(1)

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT07083193


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