Trials / Completed
CompletedNCT02452996
Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers
A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- GeNeuro Innovation SAS · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients will be evaluated in healthy male volunteers.
Detailed description
The monoclonal antibody, GNbAC1, targets the envelope protein (Env) of the human endogenous retrovirus (HERV), also called multiple sclerosis associated retrovirus (MSRV), which is considered as a critical factor in the development of multiple sclerosis. This study will assess the pharmacokinetics, safety and tolerability of GNbAC1 following single ascending doses (6, 18, and 36 mg/kg) administered via IV infusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GNbAC1 | Single dose of IMP, IV infusion |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2015-05-25
- Last updated
- 2020-10-20
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02452996. Inclusion in this directory is not an endorsement.