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

NCT07265570 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • InSilico Medicine Hong Kong Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2027-08-15
Completion
2027-08-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07265570 on ClinicalTrials.gov