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A Phase Ib/IIa Study of INT-210 Capsules in Participants With Active Ulcerative Colitis

NCT07692165 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-09

No results posted yet for this study

Summary

A Multicenter, Randomized, Open-label Clinical Study to Evaluate the Safety and Efficacy of INT-210 Capsules in Participants with Active Ulcerative Colitis.

The study aims to evaluate the safety, efficacy, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics of INT-210 in participants with active ulcerative colitis (UC).

Conditions

  • Ulcerative Colitis (UC)

Interventions

DRUG

INT-210 Capsule

All participants will receive oral treatment with INT-210 capsule 200 mg twice daily, starting from Day 1 (D1) of the treatment period (12 weeks).

DRUG

INT-210 Capsule

All participants will receive oral treatment with INT-210 capsule 400 mg twice daily, starting from Day 1 (D1) of the treatment period (12 weeks)

Sponsors & Collaborators

  • Innatus Therapeutics (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Minhu Chen · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-06-11
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

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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 NCT07692165 on ClinicalTrials.gov