5 results
Primary Objectives: - To evaluate the safety in mother and neonate/infant of nipocalimab administered to pregnant women at high risk for EOS-HDFN. - To evaluate the efficacy of nipocalimab as measured by proportion of patients with live birth at or…
FT218 is a new formulation (composition) of the registered drug sodium oxybate. Sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]) is registered under the name Xyrem® for the treatment of narcolepsy. The purpose of…
The purpose of the study is to investigate how quickly and to what extent JZP-507 is absorbed and eliminated from the body (this is called pharmacokinetics). This will be compared to the pharmacokinetics of Xyrem®. If the results show that the…
The overall objective of this trial is to evaluate the concept of pharmacological activity of BI 767551 in non-hospitalized patients with mild to moderate COVID-19 symptoms and to identify a potentially efficacious and safe dose regimen from Phase…
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (<) 18 years of age, the safety and tolerability of treatment with nipocalimab in children and…