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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT00845650
First received: February 13, 2009
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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).

Condition Intervention Phase
Anthrax
Biological: Anthrax Immune Globulin Intravenous (AIGIV)
Biological: Gamunex
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Dose-Escalation Study Evaluating Pharmacokinetics and Safety of Anthrax Immune Globulin Intravenous (AIGIV)

Resource links provided by NLM:


Further study details as provided by Emergent BioSolutions:

Primary Outcome Measures:
  • Adverse events [ Time Frame: pre-infusion, infusion, 5 minutes, 30 minutes, 8, 24, and 48 hours following infusion and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 following infusion. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • TNA (toxin neutralizing antibody) [ Time Frame: pre-infusion, 5 minutes, 8, 24, and 48 hours following infusion and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 following infusion. ] [ Designated as safety issue: No ]
  • Viral serology testing, including HBsAg, Anti-HCV, Anti-HIV-1/-2/-O, Anti-HAV Total, Anti-HBc IgM and Anti-HBc total [ Time Frame: 7-28 days before infusion and Day 90 (last visit) ] [ Designated as safety issue: Yes ]
  • Complete blood count (CBC) with differential [ Time Frame: 7 - 28 days before infusion, pre-infusion day, infusion day (before infusion), 8, 24, 48 hours and 5, 14, 45 days after infusion ] [ Designated as safety issue: Yes ]
  • Serum Chemistry [ Time Frame: 7 - 28 days before infusion, 8, 24, 48 hours and 5, 14, 45 days after infusion ] [ Designated as safety issue: Yes ]
  • Direct Coombs, haptoglobin, free hemoglobin and urine hemosiderin [ Time Frame: pre-infusion, 8, 24, 48 hours and 5 days after infusion ] [ Designated as safety issue: Yes ]
  • Urinalysis [ Time Frame: 7 - 28 days before infusion, 8, 24, 48 hours and 5, 14, 45 days after infusion ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: February 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIGIV
Three cohorts evaluating three dosage levels of AIGIV containing 3.5, 7.0, or 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Biological: Anthrax Immune Globulin Intravenous (AIGIV)
Three cohorts evaluating three dosage levels of AIGIV containing 3.5, 7.0, or 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex
Gamunex 90, 180, or 360 mg/kg total IgG as a single intravenous infusion.
Biological: Gamunex
Three cohorts evaluating three dosage levels containing Gamunex 90, 180, or 360 mg/kg total IgG as a single intravenous infusion.
Other Name: human immune globulin intravenous

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 18 and 65 years of age, inclusive.
  • Have a minimal weight of 110 lbs and a body mass index (BMI) between 17 and 35.
  • In good health.
  • For pre-menopausal female subjects, using acceptable methods of birth control.
  • Willing and capable of complying with all aspects of the protocol through completion of the program period.
  • No blood donation in the preceding 8 weeks; willing to not donate whole blood or plasma during the clinical trial; and willing to not donate whole blood or plasma for up to one year following the last infusion.
  • Has read and signed an informed consent form.
  • Adequate venous access and can receive intravenous infusion.

Exclusion Criteria:

  • Previously intolerant of immune globulin or blood product preparations or known immunodeficiency.
  • Previous treatment with immune globulin products or blood products within three months of study.
  • Previous receipt of anthrax vaccine, known exposure to anthrax organisms, or previously enlisted in the military.
  • Receipt of any live vaccine within three months or inactivated vaccine within 2 weeks prior to study; plans to receive any vaccine at any time during the study.
  • Participation in any investigational clinical trial within one month prior to study.
  • Positive serology for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
  • Receipt of chemotherapy, radiation therapy, immunosuppressive therapy, or high-dose corticosteroid therapy within five years of study.
  • Use of prohibited medications as defined in the protocol.
  • History of drug or alcohol abuse within 1 year of study.
  • History of IgA deficiency.
  • Pregnancy.
  • Positive Coombs test at screening.
  • Males with a hemoglobin value less than 13.2 gm/dL and females less than 10.9 gm/dL.
  • Absolute eosinophil counts greater than 600 cells/mm3 or Absolute lymphocyte counts less than 1000 cells/mm3.
  • Aspartate aminotransferase (AST) >55 U/L or alanine aminotransferase (ALT) >60 U/L.
  • Hyperglycemia with random blood glucose >141 mg/dL, fasting blood glucose >112 mg/dL, or urine glucose >50 mg/dL; or hypoglycemia with a blood glucose <65 mg/dL.
  • BUN >25 mg/dL or creatinine, for males >1.4 mg/dL and, for females >1.2 mg/dL.
  • Urine protein >15 mg/dL for males and non-menstruating females, or >30 mg/dL for menstruating females.
  • Febrile illness within three days prior to study.
  • History of significant medical or psychiatric condition or abnormal laboratory tests indicating possible underlying medical condition.
  • An opinion of the investigator that a condition exists that would preclude compliance with protocol-specified procedures.
  • Absolute neutrophil count is less than 3000 cells/mm3 as defined by the central lab (screening) or local lab (pre-infusion) for cohort B. Absolute neutrophil count is less than 2500 cells/mm3 as defined by the central lab (screening) or local lab (pre-infusion) for cohort C.
  • White blood cell counts are less than 3500 cells/mm3 as defined by the central lab (screening) or local lab (pre-infusion) for cohorts B and C.
  • History of a severe or anaphylactic reaction to quinolone or penicillin antibiotics.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845650

Locations
United States, Maryland
SNBL Clinical Pharmacology Center Inc.
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Emergent BioSolutions
Investigators
Principal Investigator: Mohamed Al-Ibrahim, MD SNBL Clinical Pharmacology Center Inc, Baltimore, MD
Study Director: Robert J Hopkins, MD, MPH & TM Emergent Product Development Gaithersburg
  More Information

Additional Information:
No publications provided by Emergent BioSolutions

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT00845650     History of Changes
Other Study ID Numbers: EBS.AIG.001, DMID 07-0067
Study First Received: February 13, 2009
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Emergent BioSolutions:
Anthrax
Human Anthrax Immune Globulin Intravenous
Safety
Pharmacokinetics

Additional relevant MeSH terms:
Anthrax
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014