Phase 1b2 Study of AC-101 Tablets for Adults with Moderate to Severe Active Ulcerative Colitis Evaluating Safety, Effectiveness, and Drug Behavior in the Body

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and how the body processes AC-101 tablets in adults with moderate to severe active ulcerative colitis. This study is a Phase 1b, open-label, randomized trial that plans to enroll about 24 participants aged 18 to 75 years. The goal is to better understand the treatments impact on this condition over a 17-week period. Participants will be randomly assigned to receive one of two dosing schedules of AC-101 tablets either twice daily or once daily, taken orally for 12 weeks. Before treatment starts, there is a 4-week screening period to confirm eligibility, followed by a 1-week safety follow-up after treatment ends. This setup allows researchers to compare the effects of the two dosing regimens. During the study, participants will undergo assessments to monitor any side effects and measure how well the treatment controls their ulcerative colitis symptoms. The main focus is on the occurrence and severity of adverse events up to week 13. Researchers will also evaluate the proportion of participants who achieve clinical response and remission by week 12. Regular evaluations and safety monitoring will ensure participants well-being throughout the trial.

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