drugset / Trial / NCT01699555
First-in-Human Study With GNbAC1 in Healthy Volunteers
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to assess the safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects.
Timeline
- Start
- 2011-07
- Primary completion
- 2012-03
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temelimab | Monoclonal antibody | 0.0025 mg/kg | Intravenous |
| Subject | Temelimab | Monoclonal antibody | 0.025 mg/kg | Intravenous |
| Subject | Temelimab | Monoclonal antibody | 0.15 mg/kg | Intravenous |
| Subject | Temelimab | Monoclonal antibody | 0.6 mg/kg | Intravenous |
| Subject | Temelimab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Temelimab | Monoclonal antibody | 6 mg/kg | Intravenous |