BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects
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ClinicalTrials.gov Identifier: NCT01052506 |
Recruitment Status :
Completed
First Posted : January 20, 2010
Last Update Posted : January 9, 2017
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: BIIB033 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
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 |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2011 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Single dose of saline solution (8 cohorts IV; 1 cohort SC)
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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)
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Drug: BIIB033
Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC)
Other Name: Anti-LINGO-1 antibody |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 25 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052506
United States, California | |
Research Site | |
Glendale, California, United States | |
Netherlands | |
Research Site | |
Utrecht, Netherlands |
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT01052506 |
Other Study ID Numbers: |
215HV101 |
First Posted: | January 20, 2010 Key Record Dates |
Last Update Posted: | January 9, 2017 |
Last Verified: | January 2017 |
Human volunteers |