7 results
Primary:* Evaluate the safety and tolerability of ALKS 7119 following oral administration of multiple ascending doses of ALKS 7119 in healthy male and female adultsSecondary:* Evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ALKS 7119…
To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ALKS 7119 following oral administration of single ascending doses of ALKS 7119 in healthy male adults
Primary Objectives:• To determine the Recommended Dose of Expanion or the MTD for MP0317 as monotherapy in patients with advanced solid tumors (dose-escalation part only)• To characterize the safety and tolerability of MP0317 as monotherapy in…
To evaluate the efficacy of ravulizumab compared with placebo to reduceproteinuria in adult participants with LN or IgAN.
Main objective:To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) profile.Secondary objectives:• To assess the efficacy of…
Primary:• To evaluate PK noninferiority of ravulizumab SC versus ravulizumab IV in adult patients with PNH Secondary• To characterize PK of ravulizumab SC• To characterize PD of ravulizumab SC• To characterize immunogenicity of ravulizumab SC• To…
Primary objective: To evaluate the effect of ravulizumab compared with placebo on amyotrophic lateral sclerosis functional rating scale-revised (ALSFRS-R) score in adult patients with amyotrophic lateral sclerosis (ALS).Secondary objectives:1. To…