BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BIIB033

Study type: Interventional

Funder types: Industry

Identifiers

NCT01052506

215HV101

Details and patient eligibility

About

The primary objective of the study is to evaluate the safety and tolerability of single dose of BIIB033 administered to healthy adult volunteers.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Single dose of saline solution (8 cohorts IV; 1 cohort SC)

Treatment:

Drug: Placebo

BIIB033

Experimental group

Description:

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

Treatment:

Drug: BIIB033