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

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

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(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

Conditions

Anthrax

Intervention

Anthrax Immune Globulin Intravenous (AIGIV), Gamunex

Location

SNBL Clinical Pharmacology Center Inc.
Baltimore
Maryland
United States
21201

Status

Recruiting

Source

Emergent BioSolutions

Results (where available)

View Results

Links

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

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