3 results
Primary objective:To characterize the clearance pathways, the route of excretion and the total recovery of radioactivity, PBI-4050 and its major metabolites in healthy subjects following administration of a single oral dose of 1200 mg [14C]-PBI-4050…
Phase 2:• To assess the safety, tolerability, systemic exposure, and efficacy of AMT-101 in subjects with chronic antibiotic-resistant pouchitis• To select an AMT-101 dose for Phase 3Phase 3:Co-primary Objectives:• To determine the effect of AMT-101…
To evaluate the effects of AMT-101 in combination with adalimumab on UC disease activity as measured by symptoms, endoscopy, histology, and biomarkers. To evaluate the safety and tolerability of oral AMT-101 over 8 weeksTo assess the PK parameters…