NCT01699555

First-in-Human Study With GNbAC1 in Healthy Volunteers

Randomized Placebo-Controlled First-in-Human Study With GNbAC1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: GeNeuro Innovation SAS · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects.

Detailed description

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 of 0.0025mg/kg, 0.025mg/kg, 0.15mg/kg, 0.60mg/kg, 2.00mg/kg or 6.00mg/kg
BIOLOGICAL	GNbAC1 placebo	Single dose intravenous (IV) GNbAC1 placebo

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-03-01
• Completion: 2012-08-01
• First posted: 2012-10-03
• Last updated: 2020-10-20