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Alpha-0261 Tablets for Moderate-to-Severe Ulcerative Colitis

NCT07744646 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-08-04

No results posted yet for this study

Summary

The purpose of this protocol is to evaluate the safety and efficacy of Alpha-0261 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that Alpha-0261 is safe, and the secondary hypothesis is that Alpha-0261 is effective, as assessed by the proportion of participants achieving clinical remission per the complete modified Mayo score at Week 10.

Conditions

  • Ulcerative Colitis (UC)

Interventions

DRUG

Alpha-0261

Drug: Alpha-0261 Oral, tablet

Sponsors & Collaborators

  • AlphaMol Science Ltd. (Shanghai)

    collaborator INDUSTRY

  • The First Affiliated Hospital of Anhui Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-08-03
Primary Completion
2027-01-09
Completion
2027-03-20

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 NCT07744646 on ClinicalTrials.gov