Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The primary objectives of the study are to evaluate the safety and tolerability of multiple doses of BIIB061 administered to healthy adults. The secondary objective is to determine the multiple-dose PK profile of BIIB061 in this study population.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: BIIB061
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone [FSH] levels determined at screening to be in the postmenopausal range) or surgically sterile females Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations. Must agree to abstain from alcohol ingestion for the duration of the study. Must agree to abstain from consumption of grapefruit or grapefruit-containing products for the duration of the study, starting at least 24 hours prior to admission to the inpatient facility. Must agree to abstain from taking St. John's Wort (herbal preparation) for the duration of the study Must agree to abstain from any vigorous exercise (as determined by the Investigator) for the duration of the study. Must have a body mass index of 18 to 30 kg/m2, inclusive. Key Exclusion Criteria: History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]). Presence of a metal device (e.g., any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clips; implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) that are contraindications for MRI. History of asthma, wheezing, allergies involving the lungs, or airway obstruction. History of bronchodilator or inhaler use. Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator. Inability or unwillingness to comply with study requirements. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment. Note: Other protocol defined inclusion/ exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIB061<br>Participants receive BIIB061 | Drug: BIIB061<br>* Participants receive BIIB061<br>|
| Placebo Comparator: Placebo<br>Participants receive matched placebo | Other: Placebo<br>* Matched placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing AEs |  | Up to 28 days post treatment period (Day 1 to Day 56) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma BIIB061 Concentration |  | Up to 28 days post treatment period (Day 1 to Day 56) |