4 results
Primary ObjectivesIn patients with primary hypercholesterolemia and high cardiovascular risk with LDL-C >=100 mg/dL (2.59 mmol/L) and <=160 mg/dL (4.14 mmol/L), to evaluate:1)at the end of Phase I, the additional LDL-C percentage…
The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…
The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
To assess the influence of dosing guided by AutoK on achieving PK targets and clinical endpoints in intensive care patients with sepsis.