3 results
Approved WMOCompleted
Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…
Approved WMOCompleted
Primary: to assess the bioequivalence of LH after administration of the freeze-dried (FD) Luveris formulation (Reference) versus the liquid formulation of Luveris in the pre-filled pen (Test) based on the PK parameters AUC0-t and Cmax of serum LH.…
Approved WMOCompleted
The objectives of the study are:* To evaluate the safety and tolerability of zilucoplan in subjects with IMNM* To evaluate the efficacy of zilucoplan in subjects with IMNM