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The primary objective of the study is to evaluate the safety and tolerability of single dose of BIIB033 administered to healthy adult volunteers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single dose of saline solution (8 cohorts IV; 1 cohort SC) |
|
| BIIB033 | Experimental | Single, escalating doses of BIIB033 (8 cohorts IV; 1 cohort SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB033 | Drug | Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BIIB033 serum pharmacokinetics levels | up to 4 months | |
| BIIB033 serum antibodies levels | up to 4 months | |
| Exploratory blood, urine and CSF biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25340070 | Background | 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. |
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| ID | Term |
|---|---|
| C000625770 | opicinumab |
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| Placebo | Drug | Single dose of placebo comparator (8 cohorts IV, 1 cohort SC) |
|
| up to 4 months |
| Utrecht |
| Netherlands |