Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07744646
PHASE1

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

Sponsor: The First Affiliated Hospital of Anhui Medical University

View on ClinicalTrials.gov

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.

Official title: An Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Alpha-0261 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis (UC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-08-03

Completion Date

2027-03-20

Last Updated

2026-08-04

Healthy Volunteers

No

Interventions

DRUG

Alpha-0261

Drug: Alpha-0261 Oral, tablet

Locations (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China