NCT07265570

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

A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of ISM5411 in Adult Patients With Active Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: InSilico Medicine Hong Kong Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of ISM5411 in adult patients with active ulcerative colitis.

Detailed description

ISM5411 is a gut-restricted small-molecule prolyl hydroxylase (PHD) inhibitor. It can promote the expression of intestinal mucosal protective genes and maintain the integrity and functions of intestinal barrier together with anti-inflammation. It is expected to become a safe and effective therapy to overcome the shortcomings of traditional simple anti-inflammatory drugs.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	ISM5411 tablets	Dosage Form: Tablet; Frequency of administration: Orally QD.
DRUG	ISM5411 tablets	Dosage Form: Tablet; Frequency of administration: Orally QD.
DRUG	ISM5411 tablets	Dosage Form: Tablet ; Frequency of administration: Orally QD.
DRUG	Placebo	Dosage Form: Tablet; Frequency of administration: Orally QD.

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-08-15
• Completion: 2027-08-30
• First posted: 2025-12-05
• Last updated: 2026-03-31

Locations

28 sites across 1 country: China