Pharmacokinetics and Pharmacodynamics of CinnoVex (Interferon Beta-1a) Compared to Avonex (Interferon Beta-1a)
Status:
Completed
Trial end date:
2019-02-12
Target enrollment:
Participant gender:
Summary
The primary objective of the trial is to investigate the biosimilarity of CinnoVex® by
comparing its pharmacokinetics (PK) and pharmacodynamics (PD) to its originator, Avonex®, in
a crossover manner in healthy female and male volunteers after administration of a single
dose of 30 µg or 60 µg of Interferon beta-1a.
The secondary objectives of the study are:
- To further compare the PK of CinnoVex® and Avonex®.
- To further compare the PD of CinnoVex® and Avonex®.
- To assess the safety of CinnoVex®.