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

Study Overview
=================
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 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.

Official 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

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: peginterferon beta-1a
* Drug: Rebif


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Treatment Sequence 1: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41 Treatment Sequence 2: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29 | Drug: peginterferon beta-1a<br>* Administered as subcutaneous injection<br>* Other names: Plegridy;Drug: Rebif<br>* Administered as subcutaneous injection<br>|
| Experimental: Group 2<br>Treatment Sequence 1: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29 Treatment Sequence 2: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41 | Drug: peginterferon beta-1a<br>* Administered as subcutaneous injection<br>* Other names: Plegridy;Drug: Rebif<br>* Administered as subcutaneous injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) of BIIB017 and Rebif |  | 2 weeks | 
| Number of participants experiencing Adverse Events (AE) and Serious Adverse Events (SAE) |  | Up to 4 weeks following treatment period |