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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02269930
• Date of registration: 17/10/2014
• Prospective Registration: No
• Primary sponsor: Biogen Idec
• Public title: Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
• Scientific title: 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
• Date of first enrolment: October 2014
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02269930
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen Idec

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Must have a body mass index of 19 to 30 kg/m2, inclusive, and minimum body weight of
45.0 kg at Screening and Day -1

Key Exclusion Criteria:

- History or positive test result at Screening for human immunodeficiency virus,
hepatitis C virus antibody or current hepatitis B infection (defined as positive for
hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb])

- History of premalignant and malignant disease including solid tumors and hematologic
malignancies

- Known allergy to any interferon or any component of BIIB017

- Prior treatment with any investigational drug within the 30 days prior to Day 1, or
within 5 half-lives of the drug, whichever is longer

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Rebif

Drug: peginterferon beta-1a

Primary Outcome(s)

Cumulative area under the concentration-time curve (AUC), as measured by area under the concentration-time curve from time zero to 336 hours post dose (AUC0-336h) [Time Frame: 2 weeks]

Secondary Outcome(s)

Maximum observed serum concentration (Cmax) of BIIB017 and Rebif [Time Frame: 2 weeks]

Number of participants experiencing Adverse Events (AE) and Serious Adverse Events (SAE) [Time Frame: Up to 4 weeks following treatment period]

Secondary ID(s)

105HV105

Source(s) of Monetary Support

Please refer to primary and secondary sponsors