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NOT YET RECRUITING
NCT07834515
PHASE1

Phase 1b Clinical Study in Patients With Active Ulcerative Colitis

Sponsor: Thetis Pharmaceuticals LLC

View on ClinicalTrials.gov

Summary

Purpose of study is to evaluate the safety, tolerability, pharmacokinetics of TP317 vs. placebo in adults with active ulcerative colitis. Participants will be randomly assigned to receive either daily oral tablets (8 tablets) of TP317 (80 mg) or an identical placebo pill. Study will include 2 colonoscopies, daily dosing (including at home and in clinic), safety assessments, diary and questionnaire completion and 5 in clinic visits.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy Signal of TP-317 in Patients With Active Ulcerative Colitis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-09-16

Completion Date

2027-08-29

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

DRUG

TP317

8 tablets (80 mg) of TP317 oral tablets, taken once daily under fasted conditions for a total duration of 12 weeks.

DRUG

Matching placebo

Matching oral tablet containing no active ingredients, taken once daily for 12 weeks to maintain blinding.