safety and pharmacokinetics study of anthrax immune globulin intravenous (aigiv)

Conditions: Anthrax

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).


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.

Keywords: anthrax human anthrax immune globulin intravenous safety pharmacokinetics