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BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

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ClinicalTrials.gov Identifier: NCT01052506
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIB033 Drug: Placebo Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Safety as measured by adverse event monitoring, laboratory assessments and MRI [ Time Frame: up to 4 months ]
  2. Tolerability as measured by adverse event monitoring, laboratory assessments and MRI [ Time Frame: up to 4 months ]

Secondary Outcome Measures :
  1. BIIB033 serum pharmacokinetics levels [ Time Frame: up to 4 months ]
  2. BIIB033 serum antibodies levels [ Time Frame: up to 4 months ]
  3. Exploratory blood, urine and CSF biomarkers [ Time Frame: up to 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052506


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

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01052506    
Other Study ID Numbers: 215HV101
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Keywords provided by Biogen:
Human volunteers