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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
129
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.
SNBL Clinical Pharmacology Center Inc.
Baltimore, Maryland, United States
Number of Participants Reporting Adverse Events (AEs)
Any untoward medical occurrence reported to or observed by the principal investigator (PI), including as identified from other safety assessments (eg, vital signs, clinical laboratory testing, electrocardiogram).
Time frame: From the time of infusion through Day 90.
Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax)
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. Assay results are reported as the 50% neutralization factor, TNA NF50: the ED50 of the test sample (ie, effective dilution of test sample that neutralized 50% of toxin) divided by the ED50 of the reference standard.
Time frame: From the time of infusion through Day 90 postinfusion.
Time of Cmax
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time frame: From the time of infusion through Day 90 postinfusion.
Area Under the Curve to the Last Time With a Measurable TNA Titer (AUC[0-t])
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time frame: From the time of infusion through Day 90 postinfusion.
Area Under the Curve to Infinity (AUC[0-inf])
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time frame: From the time of infusion through Day 90 postinfusion.
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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.
Elimination Rate Constant
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time frame: From the time of infusion through Day 90 postinfusion.
Elimination Half-life (t½)
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time frame: From the time of infusion through Day 90 postinfusion.
Mean Residence Time (MRT)
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time frame: From the time of infusion through Day 90 postinfusion.