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BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01052506
First received: January 15, 2010
Last updated: January 5, 2017
Last verified: January 2017

January 15, 2010
January 5, 2017
January 2010
October 2011   (Final data collection date for primary outcome measure)
  • Safety as measured by adverse event monitoring, laboratory assessments and MRI [ Time Frame: up to 4 months ]
  • Tolerability as measured by adverse event monitoring, laboratory assessments and MRI [ Time Frame: up to 4 months ]
Same as current
Complete list of historical versions of study NCT01052506 on ClinicalTrials.gov Archive Site
  • BIIB033 serum pharmacokinetics levels [ Time Frame: up to 4 months ]
  • BIIB033 serum antibodies levels [ Time Frame: up to 4 months ]
  • Exploratory blood, urine and CSF biomarkers [ Time Frame: up to 4 months ]
Same as current
Not Provided
Not Provided
 
BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • Drug: BIIB033
    Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC)
    Other Name: Anti-LINGO-1 antibody
  • Drug: Placebo
    Single dose of placebo comparator (8 cohorts IV, 1 cohort SC)
  • Placebo Comparator: Placebo
    Single dose of saline solution (8 cohorts IV; 1 cohort SC)
    Intervention: Drug: Placebo
  • Experimental: BIIB033
    Single, escalating doses of BIIB033 (8 cohorts IV; 1 cohort SC)
    Intervention: Drug: BIIB033
Tran JQ, Rana J, Barkhof F, Melamed I, Gevorkyan H, Wattjes MP, de Jong R, Brosofsky K, Ray S, Xu L, Zhao J, Parr E, Cadavid D. Randomized phase I trials of the safety/tolerability of anti-LINGO-1 monoclonal antibody BIIB033. Neurol Neuroimmunol Neuroinflamm. 2014 Aug 21;1(2):e18. doi: 10.1212/NXI.0000000000000018. eCollection 2014 Aug.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
October 2011
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands
 
 
NCT01052506
215HV101
No
Not Provided
Not Provided
Not Provided
Biogen
Biogen
Not Provided
Not Provided
Biogen
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP