A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects
Status:
Completed
Trial end date:
2017-08-06
Target enrollment:
Participant gender:
Summary
This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate
CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and
tolerability of CinnoRA®, in a parallel fashion in healthy volunteers after administration of
a single dose (40 mg) of adalimumab.
The primary objective of this study is to demonstrate that the PK of CinnoRA® is similar to
its originator, Humira®, as assessed by the area under the serum concentration time curve
(AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.
The secondary objectives of the study are:
- To further compare the PK of CinnoRA® and Humira®.
- To assess the safety of CinnoRA®.