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BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01052506
First received: January 15, 2010
Last updated: September 12, 2013
Last verified: May 2012
  Purpose

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
Healthy
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052506

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

No publications provided

Responsible Party: Medical Director, Biogen Idec, Biogen Idec
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on August 28, 2014