4 results
Primary objective:To evaluate the safety and tolerability of KY1005.Secondary objectives:To evaluate the pharmacokinetics (PK) of KY1005 following single and repeat doses.Exploratory objectives:- To evaluate the immunogenicity of KY1005;- To assess…
The primary objective is to demonstrate the efficacy using 2 co-primary endpoints (as measured by thechanges from baseline to the end of Week 16 in Western Ontario and McMaster UniversityOsteoarthritis Index [WOMAC] pain and physical function…
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…
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…