BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects - Full Text View

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT01052506

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

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:	February 16, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

Human volunteers

ClinicalTrials.gov processed this record on May 24, 2012