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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014