2 results
Approved WMOWill not start
The primary objective of the study is:Evaluate the safety of 6.0 mg/kg and 12 mg/kg SM101 per week in SLE patients with or without a history of lupus nephritis.The Secondary objective is:Evaluate the efficacy and pharmacokinetics (PK) of 6.0 mg/kg…
Approved WMOCompleted
PRIMARY* To demonstrate the non-inferiority of intravenous-to-oral antibiotic switch therapy in clinically stable neonates with probable bacterial infection compared to a complete course of intravenous antibiotic therapySECONDARY* To describe the…