NCT02269930

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	peginterferon beta-1a	Administered as subcutaneous injection
DRUG	Rebif	Administered as subcutaneous injection

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-10-21
• Last updated: 2015-02-02

Locations

1 site across 1 country: United States