At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years inclusive
- ✓Minimal weight 110 lbs with BMI 17–35
- ✓In good health
- ✓Adequate venous access for IV infusion
- ✕Previous intolerance of immune globulin or blood products, or known immunodeficiency
- ✕Prior immune globulin or blood product treatment within 3 months
- ✕Prior anthrax vaccine, known anthrax exposure, or military service
- ✕Live vaccine within 3 months, inactivated vaccine within 2 weeks, or any planned vaccination during study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Dose-Escalation Study Evaluating Pharmacokinetics and Safety of Anthrax Immune Globulin Intravenous (AIGIV)
In Brief
A Phase 2 clinical trial evaluating AIGIV 3.5 mg/kg, Gamunex 90 mg/kg, and 4 other interventions for Anthrax. Completed, enrolled 129 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 360 mg/kg total IgG as a single intravenous infusion.