BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052506
• Other study ID #: 215HV101
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2010
• Last updated: January 5, 2017
• Start date: January 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2017
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BIIB033
Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC)
• Placebo
Single dose of placebo comparator (8 cohorts IV, 1 cohort SC)

Locations

Country	Name	City	State
Netherlands	Research Site	Utrecht
United States	Research Site	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by adverse event monitoring, laboratory assessments and MRI		up to 4 months	Yes
Primary	Tolerability as measured by adverse event monitoring, laboratory assessments and MRI		up to 4 months	Yes
Secondary	BIIB033 serum pharmacokinetics levels		up to 4 months	No
Secondary	BIIB033 serum antibodies levels		up to 4 months	No
Secondary	Exploratory blood, urine and CSF biomarkers		up to 4 months	No