AnthraxPhase 1/2NCT00845650
Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
A Phase 1/2 study testing AIGIV 3.5 mg/kg, Gamunex 90 mg/kg and AIGIV 7.0 mg/kg in people with Anthrax, run by Emergent BioSolutions at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anthrax
- What is being tested?
- AIGIV 3.5 mg/kg, Gamunex 90 mg/kg and AIGIV 7.0 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Oct 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
SNBL Clinical Pharmacology Center Inc.
Baltimore, Maryland, 21201
About this study
Official title: 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).
- Conditions
- Anthrax
- Being tested
- AIGIV 3.5 mg/kg, Gamunex 90 mg/kg, AIGIV 7.0 mg/kg, Gamunex 180 mg/kg, AIGIV 14.0 mg/kg
- Keywords
- Anthrax, Human Anthrax Immune Globulin Intravenous, Safety, Pharmacokinetics
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIGIV 3.5 mg/kgBiological
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 90 mg/kgBiological
Also called human immune globulin intravenous
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
AIGIV 7.0 mg/kgBiological
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 180 mg/kgBiological
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
AIGIV 14.0 mg/kgBiological
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 360 mg/kgBiological
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| AIGIV 3.5 mg/kg (Cohort A) | Experimental | AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. Receives: Biological: AIGIV 3.5 mg/kg |
| Gamunex 90 mg/kg (Cohort A) | Other | Gamunex 90 mg/kg total IgG as a single intravenous infusion. Receives: 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. Receives: Biological: AIGIV 7.0 mg/kg |
| Gamunex 180 mg/kg (Cohort B) | Other | Gamunex 180 mg/kg total IgG as a single intravenous infusion. Receives: 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. Receives: Biological: AIGIV 14.0 mg/kg |
| Gamunex 360 mg/kg (Cohort C) | Other | Gamunex 360 mg/kg total IgG as a single intravenous infusion. Receives: Biological: Gamunex 360 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the time of infusion through Day 90.
Secondary outcomes (7)
Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax)
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.
Measured: From the time of infusion through Day 90 postinfusion.
Time of Cmax
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.
Measured: 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])
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.
Measured: From the time of infusion through Day 90 postinfusion.
Area Under the Curve to Infinity (AUC[0-inf])
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.
Measured: From the time of infusion through Day 90 postinfusion.
Elimination Rate Constant
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.
Measured: From the time of infusion through Day 90 postinfusion.
Elimination Half-life (t½)
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.
Measured: From the time of infusion through Day 90 postinfusion.
Mean Residence Time (MRT)
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.
Measured: From the time of infusion through Day 90 postinfusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnthraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Mohamed Al-Ibrahim, MD, Principal investigator, SNBL Clinical Pharmacology Center Inc, Baltimore, MDRobert J Hopkins, MD, MPH & TM, Study director, Emergent Product Development Gaithersburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845650
- Sponsor's protocol ID
- EBS.AIG.001
- Other IDs
- DMID 07-0067, HHSN272200700034C
- Status last verified
- Mar 2024
- First submitted
- 13 Feb 2009
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23979731
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Dose-Escalation Study Evaluating Pharmacokinetics and Safety of Anthrax Immune Globulin Intravenous (AIGIV)
- ClinicalTrials.gov ID
- NCT00845650
- Acronym / sponsor ID
- EBS.AIG.001
- Conditions
- Anthrax
- Keywords
- Anthrax, Human Anthrax Immune Globulin Intravenous, Safety, Pharmacokinetics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 13 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AIGIV 3.5 mg/kg (Cohort A) | Experimental | Biological: AIGIV 3.5 mg/kgAIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. |
| Gamunex 90 mg/kg (Cohort A) | Other | Biological: Gamunex 90 mg/kgGamunex 90 mg/kg total IgG as a single intravenous infusion. |
| AIGIV 7.0 mg/kg (Cohort B) | Experimental | Biological: AIGIV 7.0 mg/kgAIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| Gamunex 180 mg/kg (Cohort B) | Other | Biological: Gamunex 180 mg/kgGamunex 180 mg/kg total IgG as a single intravenous infusion. |
| AIGIV 14.0 mg/kg (Cohort C) | Experimental | Biological: AIGIV 14.0 mg/kgAIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| Gamunex 360 mg/kg (Cohort C) | Other | Biological: Gamunex 360 mg/kgGamunex 360 mg/kg total IgG as a single intravenous infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIGIV 3.5 mg/kgAIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. | Biological | AIGIV 3.5 mg/kg (Cohort A) |
| Gamunex 90 mg/kgAlso: human immune globulin intravenousGamunex 90 mg/kg total IgG as a single intravenous infusion. | Biological | Gamunex 90 mg/kg (Cohort A) |
| AIGIV 7.0 mg/kgAIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. | Biological | AIGIV 7.0 mg/kg (Cohort B) |
| Gamunex 180 mg/kgGamunex 180 mg/kg total IgG as a single intravenous infusion. | Biological | Gamunex 180 mg/kg (Cohort B) |
| AIGIV 14.0 mg/kgAIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. | Biological | AIGIV 14.0 mg/kg (Cohort C) |
| Gamunex 360 mg/kgGamunex 360 mg/kg total IgG as a single intravenous infusion. | Biological | Gamunex 360 mg/kg (Cohort C) |
Primary outcome
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).
7 secondary outcomes
Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax)
Time frame: From the time of infusion through Day 90 postinfusion.
Time of Cmax
Time frame: 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.
Area Under the Curve to Infinity (AUC[0-inf])
Time frame: From the time of infusion through Day 90 postinfusion.
Elimination Rate Constant
Time frame: From the time of infusion through Day 90 postinfusion.
Elimination Half-life (t½)
Time frame: From the time of infusion through Day 90 postinfusion.
Mean Residence Time (MRT)
Time frame: From the time of infusion through Day 90 postinfusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23979731Mytle 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.
- Sponsor websiteLink provided by the sponsor.
Related trials for Anthrax
Active, not recruitingObservational study
Effect of Activated Charcoal on Serum Osmolality, Osmolal Gap, and Enzymatic Ethylene Glycol Assay
Osmolality Disturbance, Lab Interference
RecruitingPhase 2
Combined Gastrointestinal Decontamination in Acute Severe Poisoning
Severe Poisoning With Cardiotropic or Psychotropic Drug, Admission to Intensive Care
Recruiting
Cigarette Filter Study
Smoking ( Cigarette)
Not yet recruitingPhase 4
SGLT2 Inhibitor Utilization Re-perfusion Therapy
Acute Ischemic Stroke From Large Vessel Occlusion
Not yet recruitingObservational study
Observational Study of Raxibacumab in Sporadic Cases of Systemic Anthrax
Infections, Bacterial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Al-Ibrahim, MD principal investigator
SNBL Clinical Pharmacology Center Inc, Baltimore, MD
Robert J Hopkins, MD, MPH & TM study director
Emergent Product Development Gaithersburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AIGIV 3.5 mg/kg, Gamunex 90 mg/kg and AIGIV 7.0 mg/kg in people with Anthrax, run by Emergent BioSolutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Adverse Events (AEs) (time frame: From the time of infusion through Day 90.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00845650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.