drugset / Trial / NCT00515385
A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults
Phase 1
Completed
40 enrolled
MacroGenics
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary purpose of this phase 1, double-blind, cohort study is to evaluate the safety, tolerability, and pharmacokinetics of escalating doses of MGAWN1 administered as a single intravenous (IV) infusion to healthy adults. Subjects will be enrolled sequentially into one of 5 dose-level cohorts, with 8 subjects in each cohort. Six subjects in each cohort will receive MGAWN1 (a Neutralizing, Humanized, Monoclonal Antibody (IgG1k) to West Nile Virus) and 2 will receive a saline control.
Timeline
- Start
- 2007-08
- Primary completion
- 2008-12
- Completion
- 2009-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MGAWN1 | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | MGAWN1 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | MGAWN1 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | MGAWN1 | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | MGAWN1 | Monoclonal antibody | 30 mg/kg | Intravenous |