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Completed

NCT Number: NCT01052506

BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

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

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Key information

Conditions

Healthy

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Utrecht, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIIB033

Drug

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

Other names: Anti-LINGO-1 antibody

Placebo

Drug

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

Primary outcomes

  1. Safety as measured by adverse event monitoring, laboratory assessments and MRI

    Time frame: up to 4 months

  2. Tolerability as measured by adverse event monitoring, laboratory assessments and MRI

    Time frame: up to 4 months

Secondary outcomes

  1. BIIB033 serum pharmacokinetics levels

    Time frame: up to 4 months

  2. BIIB033 serum antibodies levels

    Time frame: up to 4 months

  3. Exploratory blood, urine and CSF biomarkers

    Time frame: up to 4 months

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 20, 2010
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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