CompletedPhase 1

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

United States92 participantsStarted 2007-07

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

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 * Male…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anti-PA antibody and TNA for PK analyses.

Timeframe: screen, baseline, and D0 hours 1,3,8 and day(s) 1,3,5,7,9,11,14,21,28,42,56 and 84

Trial details

NCT IDNCT00448253

SponsorEmergent BioSolutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-08

View on ClinicalTrials.gov More Symptoms of Inhalational Anthrax trials