Cure8 trial brief
A new oral investigational drug (TP317) is entering a Phase 1b study in adults with active UC to assess safety and pharmacokinetics, which may be relevant to patients seeking information about emerging therapies.
Adults with active ulcerative colitis, clinicians treating UC, and researchers following early-stage drug development
This registry entry describes a randomized, placebo-controlled Phase 1 trial planning to enroll about 24 participants who will take TP317 80 mg (8 tablets) or matching placebo once daily for 12 weeks. The study includes baseline and Week 12 colonoscopies (with central read), regular safety assessments, ECG and laboratory monitoring, and PK sampling.
Key entry criteria require endoscopically confirmed active UC and prior inadequate response or intolerance to at least one conventional therapy; prior exposure to a single biologic, JAK, or S1P agent is allowed under specified conditions.
The record lists safety and PK endpoints (including adverse events, clinically significant lab and ECG abnormalities, and Cmax) and excludes people with severe fulminant disease or recent colectomy, among other criteria. This is a NOT_YET_RECRUITING Phase 1 interventional trial registered by Thetis Pharmaceuticals LLC.
Phase 1 trials focus on safety and PK with small numbers of participants and do not establish effectiveness. The registry entry is NOT_YET_RECRUITING; details and eligibility are specific and should be confirmed on ClinicalTrials.gov or with study sites.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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