Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
Information source: Emergent BioSolutions
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anthrax
Intervention: Anthrax Immune Globulin Intravenous (AIGIV) (Biological); Gamunex (Biological)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Emergent BioSolutions Official(s) and/or principal investigator(s):
Mohamed Al-Ibrahim, MD, Principal Investigator, Affiliation: SNBL Clinical Pharmacology Center Inc, Baltimore, MD
Robert J Hopkins, MD, MPH & TM, Study Director, Affiliation: Emergent Product Development Gaithersburg
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(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).
Clinical Details
Official title: A Randomized, Double-Blind, Dose-Escalation Study Evaluating Pharmacokinetics and Safety of Anthrax Immune Globulin Intravenous (AIGIV)
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Adverse events
Secondary outcome: TNA (toxin neutralizing antibody)Viral serology testing, including HBsAg, Anti-HCV, Anti-HIV-1/-2/-O, Anti-HAV Total, Anti-HBc IgM and Anti-HBc total Complete blood count (CBC) with differential Serum Chemistry Direct Coombs, haptoglobin, free hemoglobin and urine hemosiderin Urinalysis
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
SNBL Clinical Pharmacology Center Inc., Baltimore, Maryland 21201, United States
Additional Information
Sponsor website
Starting date: February 2009
Last updated: November 21, 2012
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