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
1 other identifier
interventional
72
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jan 2010
Longer than P75 for phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 15, 2010
CompletedFirst Posted
Study publicly available on registry
January 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJanuary 9, 2017
January 1, 2017
1.7 years
January 15, 2010
January 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety as measured by adverse event monitoring, laboratory assessments and MRI
up to 4 months
Tolerability as measured by adverse event monitoring, laboratory assessments and MRI
up to 4 months
Secondary Outcomes (3)
BIIB033 serum pharmacokinetics levels
up to 4 months
BIIB033 serum antibodies levels
up to 4 months
Exploratory blood, urine and CSF biomarkers
up to 4 months
Study Arms (2)
Placebo
PLACEBO COMPARATORSingle dose of saline solution (8 cohorts IV; 1 cohort SC)
BIIB033
EXPERIMENTALSingle, escalating doses of BIIB033 (8 cohorts IV; 1 cohort SC)
Interventions
Eligibility Criteria
You may qualify if:
- Must be in good health
- BMI of 18-30kg/m2
- Contraception required for at least 6 months after study drug administration
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (2)
Research Site
Glendale, California, United States
Research Site
Utrecht, Netherlands
Related Publications (1)
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.
PMID: 25340070BACKGROUND
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2010
First Posted
January 20, 2010
Study Start
January 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
January 9, 2017
Record last verified: 2017-01