Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy Volunteers
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the
active ingredient of Avonex®, that does not include fetal bovine serum (FBS). This
bioequivalence study is being conducted to confirm the pharmacokinetic (PK) and
pharmacodynamic (PD) comparability of Interferon beta-1a produced by the currently approved
serum-containing process and Interferon beta-1a produced by the new serum-free manufacturing
process.