Status:
COMPLETED
Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- \- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02269930
Start Date
October 1 2014
End Date
December 1 2014
Last Update
February 2 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Evansville, Indiana, United States, 47710