The purpose of this study is to assess the safety and tolerability of single ascending doses, as well as of repeated administrations of GNbAC1 in MS patients. Scientific research has shown that the expression of genes of a virus which is integrated in the Human genetic material, the Multiple Sclerosis associated RetroVirus (MSRV) could play a critical role in the causation of multiple sclerosis. GNbAC1 is an experimental medication, which neutralizes (i.e. inactivates) a protein of MSRV that might contribute to the development or deterioration of multiple sclerosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
Single dose intravenous (IV) GNbAC1 2mg/kg or 6mg/kg
Single dose intravenous (IV) GNbAC1 placebo
University Hospital Basel
Basel, Switzerland
Hopitaux Universitaires de Genève - HUG
Geneva, Switzerland
To assess the safety and tolerability of single ascending doses, as well as of repeated administrations of GNbAC1 in MS patients.
Time frame: 177 days
To determine the pharmacokinetics (PK) characteristics following administration of single ascending doses, as well as of repeated administrations, of GNbAC1 in MS patients
Time frame: 177 days
To determine pharmacodynamic markers of MS disease activity in patients including measurement of MSRV-Env markers and magnetic resonance imaging (MRI)
Time frame: 177 days
To assess the immunogenicity of GNbAC1.
Time frame: 177 days
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