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

2014-08-27 03:24:14 | BioPortfolio


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).

Study Design

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.
United States




Emergent BioSolutions

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:24:14-0400

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