Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)

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).


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years of age, inclusive.
* Have a minimal weight of 110 lbs and a body mass index (BMI) between 17 and 35.
* In good health.
* For pre-menopausal female subjects, using acceptable methods of birth control.
* Willing and capable of complying with all aspects of the protocol through completion of the program period.
* No blood donation in the preceding 8 weeks; willing to not donate whole blood or plasma during the clinical trial; and willing to not donate whole blood or plasma for up to one year following the last infusion.
* Has read and signed an informed consent form.
* Adequate venous access and can receive intravenous infusion.

Exclusion Criteria:

* Previously intolerant of immune globulin or blood product preparations or known immunodeficiency.
* Previous treatment with immune globulin products or blood products within three months of study.
* Previous receipt of anthrax vaccine, known exposure to anthrax organisms, or previously enlisted in the military.
* Receipt of any live vaccine within three months or inactivated vaccine within 2 weeks prior to study; plans to receive any vaccine at any time during the study.
* Participation in any investigational clinical trial within one month prior to study.
* Positive serology for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
* Receipt of chemotherapy, radiation therapy, immunosuppressive therapy, or high-dose corticosteroid therapy within five years of study.
* Use of prohibited medications as defined in the protocol.
* History of drug or alcohol abuse within 1 year of study.
* History of IgA deficiency.
* Pregnancy.
* Positive Coombs test at screening.
* Males with a hemoglobin value less than 13.2 gm/dL and females less than 10.9 gm/dL.
* Absolute eosinophil counts greater than 600 cells/mm3 or Absolute lymphocyte counts less than 1000 cells/mm3.
* Aspartate aminotransferase (AST) \>55 U/L or alanine aminotransferase (ALT) \>60 U/L.
* Hyperglycemia with random blood glucose \>141 mg/dL, fasting blood glucose \>112 mg/dL, or urine glucose \>50 mg/dL; or hypoglycemia with a blood glucose \<65 mg/dL.
* BUN \>25 mg/dL or creatinine, for males \>1.4 mg/dL and, for females \>1.2 mg/dL.
* Creatinine clearance \<80 mL/min.
* Urine protein \>15 mg/dL for males and non-menstruating females, or \>30 mg/dL for menstruating females.
* Febrile illness within three days prior to infusion.
* History of significant medical or psychiatric condition or abnormal laboratory tests indicating possible underlying medical condition.
* An opinion of the investigator that a condition exists that would preclude compliance with protocol-specified procedures.
* Absolute neutrophil count is less than 3000 cells/mm3 as defined by the central lab (screening) or local lab (pre-infusion) for cohort B. Absolute neutrophil count is less than 2500 cells/mm3 as defined by the central lab (screening) or local lab (pre-infusion) for cohort C.
* White blood cell counts are less than 3500 cells/mm3 as defined by the central lab (screening) or local lab (pre-infusion) for cohorts B and C.
* History of a severe or anaphylactic reaction to quinolone or penicillin antibiotics.