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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BIIB033

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands
    • Research Site
• United States
  • California
    • Glendale, California, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Single dose of saline solution (8 cohorts IV; 1 cohort SC)	Drug: Placebo; Single dose of placebo comparator (8 cohorts IV, 1 cohort SC)
Experimental: BIIB033; Single, escalating doses of BIIB033 (8 cohorts IV; 1 cohort SC)	Drug: BIIB033; Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC); Other Names: Anti-LINGO-1 antibody

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Biogen

Publications and helpful links

General Publications

• Tran JQ, Rana J, Barkhof F, Melamed I, Gevorkyan H, Wattjes MP, de Jong R, Brosofsky K, Ray S, Xu L, Zhao J, Parr E, Cadavid D. Randomized phase I trials of the safety/tolerability of anti-LINGO-1 monoclonal antibody BIIB033. Neurol Neuroimmunol Neuroinflamm. 2014 Aug 21;1(2):e18. doi: 10.1212/NXI.0000000000000018. eCollection 2014 Aug.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: January 15, 2010
• First Submitted That Met QC Criteria: January 19, 2010
• First Posted (Estimate): January 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 9, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Human volunteers
• Other Study ID Numbers: 215HV101