Phase IIa Study to Evaluate Safety and Effectiveness of Oral ISM5411 in Adults With Active Ulcerative Colitis

What this Trial Is About

Researchers are evaluating ISM5411, a gut-restricted small-molecule prolyl hydroxylase inhibitor, in adults with active ulcerative colitis. This phase IIa, multicenter, randomized, double-blind, placebo-controlled study aims to assess the safety, tolerability, pharmacokinetics, and clinical efficacy of ISM5411, which may promote intestinal mucosal protection and reduce inflammation. The study addresses limitations of traditional anti-inflammatory treatments for ulcerative colitis. Participants will be randomly assigned to one of several groups receiving either ISM5411 tablets or placebo tablets orally once daily for up to 12 weeks. The treatment groups include three cohorts receiving ISM5411 and one placebo cohort. The study monitors treatment effects and drug levels over this period to understand the drugs behavior and impact. During the study, participants will undergo regular assessments including monitoring of adverse events, vital signs, physical exams, laboratory tests blood, urine, coagulation, and ECGs. Pharmacokinetic measures such as drug concentration and elimination will also be evaluated. Safety follow-up extends to 16 weeks, and the total participation duration covers the treatment and observation periods to ensure thorough evaluation.

Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)