NCT01500408View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2012

Conditions
Multiple Sclerosis
Interventions
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)

Trial Locations (1)

Unknown

Research Site, Saint Paul

Sponsors

Lead Sponsor

Biogen
All Listed Sponsors
lead

Biogen

INDUSTRY