BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01052506

Enrollment

Registered

2010-01-20

Start date

2010-01-31

Completion date

2011-10-31

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Human volunteers

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.

Interventions

DRUGBIIB033

Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC)

DRUGPlacebo

Single dose of placebo comparator (8 cohorts IV, 1 cohort SC)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 55 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026