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 objective: • To assess the pharmacokinetics of DOR in patients prior to and after BSSecondary objectives: • To assess the safety of DOR in patients prior to and after undergoing BS• To assess the viral response to DOR in patients prior to…