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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(R)(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).
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Anthrax Immune Globulin Intravenous (AIGIV), Gamunex
SNBL Clinical Pharmacology Center Inc.
Published on BioPortfolio: 2014-08-27T03:24:14-0400
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An acute infection caused by the spore-forming bacteria BACILLUS ANTHRACIS. It commonly affects hoofed animals such as sheep and goats. Infection in humans often involves the skin (cutaneous anthrax), the lungs (inhalation anthrax), or the gastrointestinal tract. Anthrax is not contagious and can be treated with antibiotics.
ANTHRAX outbreak that occurred in 1979 and was associated with a research facility in Sverdlovsk, in the Ural mountain region of central RUSSIA. Most victims worked or lived in a narrow zone extending from the facility. The zone of anthrax-caused livestock mortality paralleled the northerly wind that prevailed shortly before the outbreak. It was concluded that an escape of ANTHRAX caused outbreak.
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A species of bacteria that causes ANTHRAX in humans and animals.
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