6 results
Primary Objectives:To assess the incidence and the time to confirmed IFI in subjects treated pre-emptively with micafungin versus placebo.
Primary objective:To determine the effect of obesity (BMI > 40kg/m2) on the pharmacokinetics of micafungin and develop a dosing regimen for obese patients. Secondary objective:* To describe the pharmacokinetics of the approved dose of 200mg…
Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…
The objective of this study is to observe the anatomical and functional outcomes of ocriplasmin over a 6-month follow-up period.
Part 1PrimaryTo assess dose limiting toxicities (DLTs) of EDR to select an RP3D for the combination to be used in Part 2 of this study.Secondary• To evaluate the overall safety profile of EDR to select an RP3D for the combination to be used in Part…
Primary:• To compare the efficacy of elranatamab vs lenalidomide Secondary:- To compare the efficacy of elranatamab vs lenalidomide- To determine the safety and tolerability of elranatamab- To evaluate the PK of elranatamab- To evaluate the…