BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

Official Title: “A Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Adult Volunteers”

The primary objective of the study is to evaluate the safety and tolerability of single dose of BIIB033 administered to healthy adult volunteers.

BIIB033 is an investigational product being developed to promote remyelination in subjects with multiple sclerosis (MS). This healthy volunteer study will evaluate safety and tolerability of a single dose of BIIB033.

Intervention(s) in this Clinical Trial

• Drug: BIIB033
  • Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC)
• Drug: Placebo
  • Single dose of placebo comparator (8 cohorts IV, 1 cohort SC)

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
  • Single dose of saline solution (8 cohorts IV; 1 cohort SC)
• Experimental: BIIB033
  • Single, escalating doses of BIIB033 (8 cohorts IV; 1 cohort SC)

Primary Measures

• Safety as measured by adverse event monitoring, laboratory assessments and MRI
  • Time Frame: up to 4 months
    Safety Issue?: Yes
• Tolerability as measured by adverse event monitoring, laboratory assessments and MRI
  • Time Frame: up to 4 months
    Safety Issue?: Yes

Secondary Measures

• BIIB033 serum pharmacokinetics levels
  • Time Frame: up to 4 months
    Safety Issue?: No
• BIIB033 serum antibodies levels
  • Time Frame: up to 4 months
    Safety Issue?: No
• Exploratory blood, urine and CSF biomarkers
  • Time Frame: up to 4 months
    Safety Issue?: No

Inclusion Criteria:

• Must be in good health
• BMI of 18-30kg/m2
• Contraception required for at least 6 months after study drug administration

Exclusion Criteria:

• History of clinically significant disease or lab values
• Females of childbearing potentials
• Contraindication to brain MRI and/or lumbar puncture
• Treatment with any prescription medication within the 28 days prior to study entry
• Treatment with any over-the-counter products, including herbal and/or alternative health preparations and procedures within the 14 days prior to study entry
• Regular use of any tobacco product within 3 months prior to study entry

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Biogen Idec Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01052506

Study ID Number: 215HV101

ClinicalTrials.gov Identifier: NCT01052506

Health Authority: United States: Food and Drug Administration