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

History of Changes

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 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

Further study details as provided by Biogen:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


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 (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

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

More Information

Publications:

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.


Responsible Party:	Biogen
ClinicalTrials.gov Identifier:	NCT01052506 History of Changes
Other Study ID Numbers:	215HV101
Study First Received:	January 15, 2010
Last Updated:	January 5, 2017

Keywords provided by Biogen:


Human volunteers

ClinicalTrials.gov processed this record on August 17, 2017

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