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

Biogen1 site in 1 country72 target enrollmentJanuary 2010

ConditionsHealthy

InterventionsPlacebo BIIB033

DrugsBIIB033 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Healthy
Sponsor: Biogen
Enrollment: 72
Locations: 1
Primary Endpoint: Safety as measured by adverse event monitoring, laboratory assessments and MRI
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

October 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

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