3 results
Primary objectivesThe primary objective of the study is demonstrate that at least one of the sotrastaurin treatment arms is non-inferior to the active control regimen myfortic + tacrolimus with respect to composite efficacy failure (treated BPAR of…
Primary objective:To demonstrate bioequivalence of GP2015 applied by an autoinjector (delta-GP2015_50) and a pre-filled syringe (PFS) as single subcutaneous injection of 50 mg to healthy adult male subjectsSecondary objectives- To study and compare…
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…