3 results
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…
The objectives of Part B of the study are as follows: Primary: To assess the safety and tolerability of CALY-002 following multiple ascending doses administered IV in subjects with coeliac disease (CeD). Secondary: (1) To characterise the PK of CALY…
In this study we will investigate how quickly and to what extend the approved compounds repaglinide, tolbutamide, midazolam or caffeine are absorbed and eliminated from the body when it is given together with PXL770. This study is a drug-drug…