Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers

Summary

The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif. The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2 weeks in healthy volunteers.

Timeline

Start

2014-10

Primary completion

2014-12

Completion

2014-12

Publications

• Hu X, Shang S, Nestorov I, Hasan J, Seddighzadeh A, Dawson K, Sperling B, Werneburg B. COMPARE: Pharmacokinetic profiles of subcutaneous peginterferon beta-1a and subcutaneous interferon beta-1a over 2 weeks in healthy subjects. Br J Clin Pharmacol. 2016 Aug;82(2):380-8. doi: 10.1111/bcp.12968. Epub 2016 May 29.

Drugs

Indications