2 results
Approved WMOCompleted
MAIN OBJECTIVESDose escalation study:To establish the safe use of trastuzumab (Synthon BV, the Netherlands) in healthy volunteers at different dose levels up to 6 mg/kg.Bioequivalence study:Demonstrate bioequivalence between trastuzumab (Synthon BV…
Approved WMOCompleted
Primary Efficacy Objective (Blinded Treatment Period)• To demonstrate the efficacy of rilzabrutinib versus placebo in participants with refractory/relapsed ITP, based on the durability of platelet response during the last12 weeks of the 24-week…