NCT01639300

Safety Study of GNbAC1 in Multiple Sclerosis Patients

Randomised Placebo-Controlled Single Blind Study to Investigate Single Ascending Doses of GNbAC1 in Multiple Sclerosis Patients Followed by Open-label Extension With Repeated Doses of GNbAC1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: GeNeuro Innovation SAS · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	GNbAC1	Single dose intravenous (IV) GNbAC1 2mg/kg or 6mg/kg
BIOLOGICAL	GNbAC1 placebo	Single dose intravenous (IV) GNbAC1 placebo

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-07-12
• Last updated: 2021-02-08

Locations

2 sites across 1 country: Switzerland