2 results
Approved WMOCompleted
Primairy objectivesTo study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants <= 90 days of postnatal age with probable or confirmed bacterial meningitis (BM); To describe the safety profile of meropenem in the…
Approved WMOCompleted
Primary:To assess the safety and tolerability of MCLA-117, in order to determine the MTD/RP2D and frequency of administration.Secondary:- To assess the pharmacokinetic (PK) profile of MCLA-117 i.v. infusion- To investigate the pharmacodynamic (PD)…