Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum

Completed · Phase 1 · Has a placebo group

Conditions studied: Symptoms of Inhalational Anthrax

In brief

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 laboratory assessments. To determine the dose proportionality relation of three different doses of NP-015.

Key facts

Study ID

NCT00448253

Run by

Emergent BioSolutions

People needed

92

Starts

2007-07-01

Expected to finish

2008-09-01

Last updated by the study team

2024-03-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MDS Pharma Services — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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