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

NCT00845650 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2024-03-18

Study results available
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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

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • Mohamed Al-Ibrahim, MD · SNBL Clinical Pharmacology Center Inc, Baltimore, MD

  • Robert J Hopkins, MD, MPH & TM · Emergent Product Development Gaithersburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00845650 on ClinicalTrials.gov