drugset / Trial / NCT00845650
Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to: * evaluate the safety profile of a single intravenous administration of AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as compared with either 90 mg/kg, 180 mg/kg or 360 mg/kg total IgG, GAMUNEX® (immune globulin intravenous (human) 10% caprylate/chromatography purified). GAMUNEX is a trademark of Talecris Biotherapeutics. * evaluate the pharmacokinetic (PK) profile of a single intravenous administration of AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as measured by lethal toxin neutralizing antibody (TNA).
Timeline
- Start
- 2009-02
- Primary completion
- 2010-10
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anthrax Immune Globulin Intravenous | Protein / enzyme biologic | 3.5 mg/kg | Intravenous |
| Subject | Anthrax Immune Globulin Intravenous | Protein / enzyme biologic | 7 mg/kg | Intravenous |
| Subject | Anthrax Immune Globulin Intravenous | Protein / enzyme biologic | 14 mg/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 90 mg/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 180 mg/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 360 mg/kg | Intravenous |