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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00138411 record still lists
NCT00138411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Ciprofloxacin 500 mg is the first listed.
NCT00138411 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00138411's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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