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: June 7, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 15, 2010
Last Updated Date	June 7, 2012
Start Date ^ICMJE	January 2010
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 19, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01052506 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 19, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects
Official Title ^ICMJE	A Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Adult Volunteers
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.
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 Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Healthy
Intervention ^ICMJE	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)
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	72
Completion Date	October 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Both
Ages	25 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01052506
Other Study ID Numbers ^ICMJE	215HV101
Has Data Monitoring Committee	No
Responsible Party	Medical Director, Biogen Idec, Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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