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

Information source: Emergent BioSolutions
Information obtained from ClinicalTrials.gov on October 04, 2010
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: Recruiting

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

Overall contact:
Katrina Crawford, Phone: (410) 706-8837, Email: kcrawford@snbl-cpc.com

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, Control: Dose Comparison, 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

Katrina Crawford, Phone: (410) 706-8837, Email: kcrawford@snbl-cpc.com

SNBL Clinical Pharmacology Center Inc., Baltimore, Maryland 21201, United States; Recruiting
Mohamed Al-Ibrahim, MD, Phone: 410-706-8877
Mohamed Al-Ibrahim, MD, Principal Investigator
Additional Information

Sponsor website

Starting date: February 2009
Last updated: May 14, 2010

Page last updated: October 04, 2010

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