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A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis

NCT07083193 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-07-24

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of AC-101 tablets in participants with moderate-to-severe ulcerative colitis.

The total study duration is up to 17 weeks, including 4-week screening, 12-week treatment period, and 1-week safety follow-up.

The study will enroll approximately 24 participants with moderate to severe active ulcerative colitis.

Conditions

Interventions

DRUG

AC-101

AC-101 tablets will be administered orally.

Sponsors & Collaborators

  • Accro Bioscience (Suzhou) Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2026-09-30
Completion
2027-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT07083193 on ClinicalTrials.gov