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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00622609 |
GSK249320 is a monoclonal antibody directed against myelin associated glycoprotein (MAG), a protein that inhibits axonal regeneration. GSK249320 acts as a MAG antagonist, and through this activity it is hypothesised that it will enhance recovery from neuronal degeneration following acute axonal injury, which occurs in spinal cord injury or stroke.
Condition | Intervention | Phase |
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Chronic Diseases Associated With Axonal Damage |
Drug: GSK249320 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Parallel Assignment, Safety Study |
Official Title: | A Single-Blind, Single Dose, Placebo Controlled, Parallel Group, First Time in Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Ascending IV Doses of GSK249320 in Healthy Volunteers |
Estimated Enrollment: | 52 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | April 2009 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
GSK Investigational Site | |
Baltimore, Maryland, United States, 21225 | |
Australia, New South Wales | |
GSK Investigational Site | |
Randwick, Sydney, New South Wales, Australia, 2031 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | MAG103114 |
Study First Received: | February 13, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00622609 |
Health Authority: | United States: Food and Drug Administration |
monoclonal antibody, GSK249320, healthy subjects, first time in human, MAG |
Antibodies, Monoclonal Antibodies Chronic Disease Healthy Immunoglobulins |
Disease Attributes Pathologic Processes |