Status:
COMPLETED
Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum
Lead Sponsor:
Emergent BioSolutions
Collaborating Sponsors:
Department of Health and Human Services
Conditions:
Symptoms of Inhalational Anthrax
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420 or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse events and labo...
Detailed Description
* The test product is Anthrax Immune Globulin Intravenous (Human), NP-015. * The product is supplied as a sterile liquid suitable for IV administration. * Product potency is expressed in units of anth...
Eligibility Criteria
Inclusion
- Male or female
- Age 18/19 (dependent on local age of majority) - 55 years
- Body mass index of 19 - 29
- For female subjects that are not surgically sterilized, willingness to use an effective method of contraception throughout the trial including:
- Using hormonal contraception (oral, injectable or implant) continuously for 3 months prior to the start of the trial and willing to continue to use hormonal contraception throughout the entire trial.
- IUD inserted at least 3 months prior to dosing.
- For female subjects who are postmenopausal \< 2 years an FSH ≥ 40 mIU/mL must be obtained. If the FSH is \< 40 mIU/mL the subject must agree to use an acceptable form of contraception (see above).
- For males that have not had a vasectomy, willingness to use a condom with spermicide for the duration of the study. Also, male subjects must not donate sperm for the duration of the study.
- Normal and healthy as determined by medical history, physical exam, ECG, vital signs and laboratory tests of liver, kidney and hematological functions
- Written informed consent
Exclusion
- Heavy smokers (\>10 cigarettes/day) or individuals using smokeless tobacco or nicotine containing products
- Use of any investigational product within the past 30 days
- Recipient of any blood product within the past 12 months
- Plasma donation within 7 days or significant blood loss or blood donation within 56 days of baseline
- Females with a hemoglobin level \< 12 g/dL
- Males with a hemoglobin level \< 13 g/dL
- History of hypersensitivity to blood products
- History of allergy to latex or rubber
- History of IgA deficiency
- Pregnancy or lactation
- Positive serology test for HIV or HCV, positive test for HBV as determined by HBsAg.
- History of, or suspected substance abuse problem (including alcohol)
- Failure of drug test at screening or baseline
- Failure of alcohol test at baseline or consumption of alcoholic beverages within 48 hours of baseline
- History of anthrax vaccination with AVA or any other anthrax vaccine
- Individuals with planned medical procedures that will occur during the study
- Use of prescription medications within 7 days prior to baseline, or anticipated use during the study (with the exception of hormonal contraceptives for females)
- Use of over-the-counter, herbal medications or vitamins within 7 days of study admission
- An opinion of the investigator that it would be unwise to allow participation of the subject in the study
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00448253
Start Date
July 1 2007
End Date
September 1 2008
Last Update
March 15 2024
Active Locations (1)
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1
MDS Pharma Services
Lincoln, Nebraska, United States, 68502