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

This is an interventional treatment trial for Anthrax focused on measuring Anthrax, Human Anthrax Immune Globulin Intravenous, Safety, Pharmacokinetics Read More

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.