NCT00845650

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

A Randomized, Double-Blind, Dose-Escalation Study Evaluating Pharmacokinetics and Safety of Anthrax Immune Globulin Intravenous (AIGIV)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Anthrax

Interventions

Type	Name	Description
BIOLOGICAL	AIGIV 3.5 mg/kg	AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
BIOLOGICAL	Gamunex 90 mg/kg	Gamunex 90 mg/kg total IgG as a single intravenous infusion.
BIOLOGICAL	AIGIV 7.0 mg/kg	AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
BIOLOGICAL	Gamunex 180 mg/kg	Gamunex 180 mg/kg total IgG as a single intravenous infusion.
BIOLOGICAL	AIGIV 14.0 mg/kg	AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
BIOLOGICAL	Gamunex 360 mg/kg	Gamunex 360 mg/kg total IgG as a single intravenous infusion.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-02-18
• Last updated: 2024-03-18
• Results posted: 2018-06-13

Locations

1 site across 1 country: United States