2 results
Approved WMOCompleted
Primary Objective•*To evaluate the relative oral bioavailability of SMV, ODV, and AL-335 when administered as different concept fixed-dose combination (FDC) formulations compared to the single agents when administered together, all under fed…
Approved WMOCompleted
Primary objectives: 1. To compare the efficacy of vamorolone administered orally at daily doses of 6.0 mg/kg over a 24-week treatment period vs. placebo in ambulant boys ages 4 to <7 years with DMD; and2. To evaluate the safety and…