Status:
COMPLETED
Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
Lead Sponsor:
Emergent BioSolutions
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Anthrax
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 eith...
Eligibility Criteria
Inclusion
- 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
- 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.
- Creatinine clearance \<80 mL/min.
- 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 infusion.
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00845650
Start Date
February 1 2009
End Date
October 1 2010
Last Update
March 18 2024
Active Locations (1)
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1
SNBL Clinical Pharmacology Center Inc.
Baltimore, Maryland, United States, 21201