NCT07083193

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Accro Bioscience (Suzhou) Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	AC-101	AC-101 tablets will be administered orally.

Timeline

• Start date: 2025-01-20
• Primary completion: 2026-09-30
• Completion: 2027-04-30
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: China