The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein that prevents nerve growth. The trial is expected to involve approximately 36 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses in patients with Multiple Sclerosis (MS).
This is a phase I study of GSK1223249. The study design is randomized, placebo-controlled, double-blind, sequential dose escalation, single dose administration. Approximately 36 patients with relapsing forms of Multiple Sclerosis (having had at least two relapses over the previous 24 months, OR at least one relapse within the last 12 months, OR having had at least one documented gadolinium-enhancing lesion on brain magnetic resonance imaging (MRI) within 12 months prior to Screening) will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
Placebo
I.V. Infusion
GSK Investigational Site
Heidelberg, Victoria, Australia
The preliminary safety and tolerability of single doses of GSK1223249
changes in Vital signs, Electocardiogram, safety laboratory samples, adverse event (AE), neurological examination and MS relapses
Time frame: screening, baseline (pre-dose) and up to 84 days post dose
Single dose pharmacokinetics.
(AUC(0-∞)
Time frame: screening, baseline (pre-dose) and up to 84 days post dose
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