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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
8 tablets (80 mg) of TP317 oral tablets, taken once daily under fasted conditions for a total duration of 12 weeks.
Matching oral tablet containing no active ingredients, taken once daily for 12 weeks to maintain blinding.
Safety of TP317
Incidence, duration and severity of all adverse events (AEs).
Time frame: Collected from baseline through Week 12
Safety of TP317
Number of Participants with Clinically Significant Laboratory Abnormalities
Time frame: Baseline through Week 12
Safety of TP317
Number of Participants with Clinically Significant ECG Abnormalities
Time frame: Baseline through Week 12
Safety of TP317
Changes in 12-lead electrocardiogram parameters
Time frame: Baseline to Week 12
Pharmacokinetics of TP317
Maximum observed plasma concentration (Cmax) of TP317
Time frame: Baseline through Week 12
Pharmacokinetics of TP317
Time to maximum observed plasma concentration (Tmax) of TP317
Time frame: Baseline through Week 12
Pharmacokinetics of TP317
Area under the plasma concentration-time curve
Time frame: Baseline through Week 12
Pharmacokinetics of TP317
Plasma elimination half-life (t1/2) of TP317
Time frame: Baseline through Week 12
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