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

March 14, 2024 updated by: Emergent BioSolutions

A Randomized, Double-Blind, Dose-Escalation Study Evaluating Pharmacokinetics and Safety of Anthrax Immune Globulin Intravenous (AIGIV)

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® (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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • SNBL Clinical Pharmacology Center Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AIGIV 3.5 mg/kg (Cohort A)
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
Biological: AIGIV 3.5 mg/kg
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
Other: Gamunex 90 mg/kg (Cohort A)
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
Biological: Gamunex 90 mg/kg
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
Other Names:
  • human immune globulin intravenous
Experimental: AIGIV 7.0 mg/kg (Cohort B)
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
Biological: AIGIV 7.0 mg/kg
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
Other: Gamunex 180 mg/kg (Cohort B)
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
Biological: Gamunex 180 mg/kg
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
Experimental: AIGIV 14.0 mg/kg (Cohort C)
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Biological: AIGIV 14.0 mg/kg
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Other: Gamunex 360 mg/kg (Cohort C)
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
Biological: Gamunex 360 mg/kg
Gamunex 360 mg/kg total IgG as a single intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Adverse Events (AEs)
Time Frame: From the time of infusion through Day 90.
Any untoward medical occurrence reported to or observed by the principal investigator (PI), including as identified from other safety assessments (eg, vital signs, clinical laboratory testing, electrocardiogram).
From the time of infusion through Day 90.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax)
Time Frame: From the time of infusion through Day 90 postinfusion.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. Assay results are reported as the 50% neutralization factor, TNA NF50: the ED50 of the test sample (ie, effective dilution of test sample that neutralized 50% of toxin) divided by the ED50 of the reference standard.
From the time of infusion through Day 90 postinfusion.
Time of Cmax
Time Frame: From the time of infusion through Day 90 postinfusion.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
From the time of infusion through Day 90 postinfusion.
Area Under the Curve to the Last Time With a Measurable TNA Titer (AUC[0-t])
Time Frame: From the time of infusion through Day 90 postinfusion.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
From the time of infusion through Day 90 postinfusion.
Area Under the Curve to Infinity (AUC[0-inf])
Time Frame: From the time of infusion through Day 90 postinfusion.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
From the time of infusion through Day 90 postinfusion.
Elimination Rate Constant
Time Frame: From the time of infusion through Day 90 postinfusion.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
From the time of infusion through Day 90 postinfusion.
Elimination Half-life (t½)
Time Frame: From the time of infusion through Day 90 postinfusion.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
From the time of infusion through Day 90 postinfusion.
Mean Residence Time (MRT)
Time Frame: From the time of infusion through Day 90 postinfusion.
Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
From the time of infusion through Day 90 postinfusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emergent BioSolutions

Collaborators

National Institutes of Health (NIH)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (Estimated)

February 18, 2009

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBS.AIG.001
  • DMID 07-0067 (Other Identifier: NIAID)
  • HHSN272200700034C (Other Grant/Funding Number: NIAID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anthrax

Clinical Trials on AIGIV 3.5 mg/kg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe