BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIIB033
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Single dose of saline solution (8 cohorts IV; 1 cohort SC) | Drug: Placebo<br>* Single dose of placebo comparator (8 cohorts IV, 1 cohort SC)<br>|
| Experimental: BIIB033<br>Single, escalating doses of BIIB033 (8 cohorts IV; 1 cohort SC) | Drug: BIIB033<br>* Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC)<br>* Other names: Anti-LINGO-1 antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human volunteers