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

Emergent BioSolutions1 site in 1 country129 target enrollmentFebruary 2009

ConditionsAnthrax

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Anthrax
Sponsor: Emergent BioSolutions
Enrollment: 129
Locations: 1
Primary Endpoint: Number of Participants Reporting Adverse Events (AEs)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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).

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

October 2010

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Emergent BioSolutions

Responsible Party

Sponsor

Eligibility 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
•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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

Area Under the Curve to the Last Time With a Measurable TNA Titer (AUC[0-t])(From the time of infusion through Day 90 postinfusion.)
Time of Cmax(From the time of infusion through Day 90 postinfusion.)
Mean Residence Time (MRT)(From the time of infusion through Day 90 postinfusion.)
Elimination Half-life (t½)(From the time of infusion through Day 90 postinfusion.)
Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax)(From the time of infusion through Day 90 postinfusion.)
Area Under the Curve to Infinity (AUC[0-inf])(From the time of infusion through Day 90 postinfusion.)
Elimination Rate Constant(From the time of infusion through Day 90 postinfusion.)