drugset / Trial / NCT01639300
Safety Study of GNbAC1 in Multiple Sclerosis Patients
RandomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2012-07
- Primary completion
- 2014-04
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temelimab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Temelimab | Monoclonal antibody | 6 mg/kg | Intravenous |