NCT01500408

Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy Volunteers

A Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of Interferon Beta-1a Manufactured by Two Different Processes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Interferon beta-1a (current approved manufacturing process invloving FBS)	Single dose of 60 mcg given Intramuscularly (IM)
DRUG	Interferon beta-1a (new process, manufactured without FBS)	Single dose of 60 mcg given Intramuscularly (IM)

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-12-28
• Last updated: 2012-11-19

Locations

1 site across 1 country: United States