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
ObjectivesPrimary Efficacy Objective• To assess the sustained clinical effect of BM32 during 2 consecutive treatment years compared to placebo. The clinical effect of BM32 is evaluated by a combined Symptom-Medication-Score (SMS) which is recorded…