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NCT00138411 · ClinicalTrials.gov registry record · Phase 1
Monoclonal Antibody for Treatment of Inhalation Anthrax
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00138411 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants.
The verdict
NCT00138411, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study 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.
Interventions
- DRUG Ciprofloxacin 500 mg
- DRUG ETI-204 (Anthim)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2005-10 |
| Est. Completion | 2006-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00138411
The ClinicalTrials.gov registry entry for NCT00138411 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ciprofloxacin 500 mg is the first listed.
NCT00138411 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00138411 about?
NCT00138411 is a clinical study titled "Monoclonal Antibody for Treatment of Inhalation Anthrax". 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 pharma...
What is the current status of trial NCT00138411?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2005-10. Estimated completion is 2006-03.
What interventions are being tested in trial NCT00138411?
The interventions under investigation include: Ciprofloxacin 500 mg (DRUG), ETI-204 (Anthim) (DRUG).
Who is sponsoring clinical trial NCT00138411?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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