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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Anthrax
Interventions
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.

Trial Locations (1)

21201

SNBL Clinical Pharmacology Center Inc., Baltimore

Sponsors
All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

lead

Emergent BioSolutions

INDUSTRY