Phase 1b Clinical Study in Patients With Active Ulcerative Colitis

Study acronym: TP317-301
StatusNot Yet Recruiting
PhasePhase 1
Started

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Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07834515
Lead Sponsor Thetis Pharmaceuticals LLC
Conditions
(from sponsor)		 Ulcerative Colitis (UC)
Related terms Colitis, Ulcerative
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov