BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

This study has been completed.
Information provided by:
Biogen Idec Identifier:
First received: January 15, 2010
Last updated: September 12, 2013
Last verified: May 2012

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

Condition Intervention Phase
Drug: BIIB033
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Adult Volunteers

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Safety as measured by adverse event monitoring, laboratory assessments and MRI [ Time Frame: up to 4 months ] [ Designated as safety issue: Yes ]
  • Tolerability as measured by adverse event monitoring, laboratory assessments and MRI [ Time Frame: up to 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • BIIB033 serum pharmacokinetics levels [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]
  • BIIB033 serum antibodies levels [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]
  • Exploratory blood, urine and CSF biomarkers [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Single dose of saline solution (8 cohorts IV; 1 cohort SC)
Drug: Placebo
Single dose of placebo comparator (8 cohorts IV, 1 cohort SC)
Experimental: BIIB033
Single, escalating doses of BIIB033 (8 cohorts IV; 1 cohort SC)
Drug: BIIB033
Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC)
Other Name: Anti-LINGO-1 antibody

Detailed Description:

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.


Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01052506

United States, California
Research Site
Glendale, California, United States
Research Site
Utrecht, Netherlands
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Medical Director, Biogen Idec, Biogen Idec Identifier: NCT01052506     History of Changes
Other Study ID Numbers: 215HV101
Study First Received: January 15, 2010
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Human volunteers processed this record on April 23, 2014