BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects
- Registration Number
- NCT01052506
- Lead Sponsor
- Biogen
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Single dose of saline solution (8 cohorts IV; 1 cohort SC) BIIB033 BIIB033 Single, escalating doses of BIIB033 (8 cohorts IV; 1 cohort SC)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇳🇱Utrecht, Netherlands