2 results
Approved WMOCompleted
Primary objective: Study Part 1 : Single Ascending Dose: • To determine the clinical and biological safety and tolerability of oxathridine after an oral increasing single dose administration oxathridine in healthy male subjects. Study Part 2 : Proof…
Approved WMOCompleted
Primary:To assess the safety and tolerability of Firdapse after single and multiple doses Secondary:Part 1 only: To determine the dose-related PK profile of single, escalating doses of Firdapse;Part 2 only: To assess the steady-state plasma PK and…