Monoclonal Antibody for Treatment of Inhalation Anthrax (NCT00138411) | Clinical Trial Compass
CompletedPhase 1
Monoclonal Antibody for Treatment of Inhalation Anthrax
United States36 participantsStarted 2005-10
Plain-language summary
The purpose of this study is to evaluate the safety and pharmacokinetics (how long a drug stays in the bloodstream and how high the levels of the drug are at different times) of ETI-204 following intravenous (IV-into a vein) injections, and to evaluate the effects that ETI-204 may have on the pharmacokinetics of oral (by mouth) ciprofloxacin, an antibiotic approved by the U.S. Food and Drug Administration (FDA). ETI-204 is an experimental drug (not approved by the FDA) intended to protect against anthrax (a bacterial infection). Approximately 36 male and female healthy volunteers ages 18 to 50 will be in this study. Participation in this study may last up to eight weeks. Volunteers will have a single IV dose of the ETI-204 study drug or placebo (inactive substance, and some participants will also receive ciprofloxacin. They will stay in the Clinical Pharmacology Unit at least 36 hours after the dose.
Who can participate
Age range
18 Years – 50 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
. Healthy male or female subjects between the ages of 18-50 inclusive at the time of enrollment. In each of the drug cohorts (subgroups), at least two of the subjects must be female.
. The following screening laboratory parameters must be within the normal range: AST, ALT, alkaline phosphatase, hemoglobin, and serum creatinine. No repeat testing is allowed for these analytes. For any other clinical chemistry analyte or CBC (including differential and platelet count) parameter that is outside the normal range, the PI and the sponsor's medical monitor will confer and must agree in writing that the value has no clinical significance before the subject will be allowed to enter the study.
. The values for the following tests at screening are to be:
. Female subjects of childbearing potential must agree to practice abstinence or to use a licensed, effective form of birth control (e.g., oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, intrauterine contraceptive device, Depo-Provera®, skin patch, vaginal ring, or cervical cap) for at least 30 days prior to enrollment and for the duration of the study, including the follow-up period. Females using hormonal contraceptives must agree to use at least one other method for at least 30 days prior to enrollment and for the duration of the study, including the follow-up period.
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.
Trial details
NCT IDNCT00138411
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Female subjects must have a negative pregnancy test.
. No history of hospitalization for illness within the six months prior to study enrollment.
. Non-smoker or ex-smoker. If a subject is an ex-smoker, he/she must not have used nicotine for at least 6 months prior to enrollment. This will be confirmed by a negative urine test for cotinine.
. Able to spend the two days specified in the study schedule confined in a facility under study rules.
Exclusion criteria
. Routine consumption of any medication (prescription or OTC), vitamin, mineral, antacid, or dietary supplement, for one week before and during the study. The sole exception are hormonal contraceptive agents, as detailed above, hormone replacement therapy, and thyroid replacement therapy. Subjects must be specifically reminded that antacids are excluded.
. Blood pressure greater than 145 mm Hg systolic and 95 mm Hg diastolic.
. Contraindication to the use of ciprofloxacin or any quinolone. (Part 2 only).
. Contraindication to the use of any monoclonal antibody.
. Medical condition that in the Investigator's opinion could adversely impact the subject's participation, safety or conduct of the study.
. Subject has taken an investigational medication in the previous three months.
. The subject has a history of drug or alcohol abuse within the past two years.
. The subject is female and plans to become pregnant during the study or the 42 day follow-up period.