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

NCT00845650 | Completed Phase 1 Results DMC

• 3 other identifiers: EBS.AIG.001DMID 07-0067HHSN272200700034C
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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).

Conditions

Anthrax

Keywords

Anthrax; Human Anthrax Immune Globulin Intravenous; Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Adverse Events (AEs)

  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 Outcomes (7)

• Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax)

  From the time of infusion through Day 90 postinfusion.

• Time of Cmax

  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])

  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.

Study Arms (6)

AIGIV 3.5 mg/kg (Cohort A)

EXPERIMENTAL

AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.

Biological: AIGIV 3.5 mg/kg

Gamunex 90 mg/kg (Cohort A)

OTHER

Gamunex 90 mg/kg total IgG as a single intravenous infusion.

Biological: Gamunex 90 mg/kg

AIGIV 7.0 mg/kg (Cohort B)

EXPERIMENTAL

AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.

Biological: AIGIV 7.0 mg/kg

Gamunex 180 mg/kg (Cohort B)

OTHER

Gamunex 180 mg/kg total IgG as a single intravenous infusion.

Biological: Gamunex 180 mg/kg

AIGIV 14.0 mg/kg (Cohort C)

EXPERIMENTAL

AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.

Biological: AIGIV 14.0 mg/kg

Gamunex 360 mg/kg (Cohort C)

OTHER

Gamunex 360 mg/kg total IgG as a single intravenous infusion.

Biological: Gamunex 360 mg/kg

Interventions

AIGIV 3.5 mg/kg BIOLOGICAL

AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.

AIGIV 3.5 mg/kg (Cohort A)

Gamunex 90 mg/kg BIOLOGICAL

Gamunex 90 mg/kg total IgG as a single intravenous infusion.

Also known as: human immune globulin intravenous

Gamunex 90 mg/kg (Cohort A)

AIGIV 7.0 mg/kg BIOLOGICAL

AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.

AIGIV 7.0 mg/kg (Cohort B)

Gamunex 180 mg/kg BIOLOGICAL

Gamunex 180 mg/kg total IgG as a single intravenous infusion.

Gamunex 180 mg/kg (Cohort B)

AIGIV 14.0 mg/kg BIOLOGICAL

AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.

AIGIV 14.0 mg/kg (Cohort C)

Gamunex 360 mg/kg BIOLOGICAL

Gamunex 360 mg/kg total IgG as a single intravenous infusion.

Gamunex 360 mg/kg (Cohort C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

SNBL Clinical Pharmacology Center Inc.

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Mytle N, Hopkins RJ, Malkevich NV, Basu S, Meister GT, Sanford DC, Comer JE, Van Zandt KE, Al-Ibrahim M, Kramer WG, Howard C, Daczkowski N, Chakrabarti AC, Ionin B, Nabors GS, Skiadopoulos MH. Evaluation of intravenous anthrax immune globulin for treatment of inhalation anthrax. Antimicrob Agents Chemother. 2013 Nov;57(11):5684-92. doi: 10.1128/AAC.00458-13. Epub 2013 Aug 26.

  PMID: 23979731 DERIVED

Related Links

• Sponsor website

MeSH Terms

Conditions

Anthrax

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Emergent Product Development Gaithersburg, Inc.

clinicalstudies@ebsi.com

Study Officials

• Mohamed Al-Ibrahim, MD

  SNBL Clinical Pharmacology Center Inc, Baltimore, MD

  PRINCIPAL INVESTIGATOR

• Robert J Hopkins, MD, MPH & TM

  Emergent Product Development Gaithersburg

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 18, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 18, 2024
• Results First Posted: June 13, 2018

Record last verified: 2024-03

Locations

US (1)