3 results
The study will be performed in 2 parts, Parts 1 and 2. The volunteers can only participate in one of the two parts of this study. The purpose of Part 1 of the study is to investigate to what extent RO6806127 is tolerated. It will also be…
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.…
Primary:The primary objective of the study is to evaluate the efficacy of KPL-301 versus placebo, coadministeredwith a 26 week steroid taper, for maintaining sustained remission for 26 weeks in subjects with newonsetor relapsing/refractory giant…