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

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.