5 results
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…
Primary objective:1. Reduction of hospitality duration in patients with CAP treated with intravenous dexamethasone. Secondary objective:1. Reduction of the use of intravenous antibiotics in patients with CAP treated with intravenous dexamethasone.2…
The primary safety objective of this investigation is to assess the safety of long-term LES electrical stimulation therapy in patients with GERD.The primary functionality objective of this study is to evaluate the ability of the device to initiate…
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 evaluate the safety and efficacy of long term stimulation of the lower esophageal sphincter in patients with gastroesophageal reflux disease after sleeve gastrectomy.