AgingResearch.NewsJoin free

Phase 2Recruiting

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

Sponsor
InSilico Medicine Hong Kong Limited (Industry)
Enrolment
80 planned
Conditions
Ulcerative Colitis
Interventions
ISM5411 tablets; ISM5411 tablets; ISM5411 tablets; Placebo
Ages
adults, older adults
Registry
NCT07265570

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • The rate of treatment-emergent adverse events (TEAEs) in each group.
  • The rate of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation of treatment in each group.
  • Changes and comparisons of the following data for each group of subjects: vital signs, physical examination, laboratory test(blood routine, blood chemistry, urinalysis, coagulation function, etc.), ECG(Heart rate, RR, PR, QRS,QT, QTcF ), etc.

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered