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NCT01932437 · ClinicalTrials.gov registry record · Phase 1
Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers
A Phase 1 study of Inhalational Anthrax, sponsored by Elusys Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01932437: Completed Phase 1 study of Inhalational Anthrax, sponsored by Elusys Therapeutics.
NCT01932437 is a Phase 1 study of Inhalational Anthrax that has completed, run by Elusys Therapeutics. 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). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01932437, a Phase 1 study of Inhalational Anthrax, has completed, sponsored by Elusys Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers
Primary Outcome
Safety was assessed for all subjects in the Safety Population by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical examinations, injection site assessments, skin assessments for presence/absence of rash, and adverse events (AEs).
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL ETI-204
Study Locations (1)
Texas
- Covance Clinical Research Unit Inc. - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-07-26 |
| Est. Completion | 2014-07-03 |
| Phase | Phase 1 |
What the finished NCT01932437 record still lists
NCT01932437 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 1 condition, with Inhalational Anthrax appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01932437 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01932437 about?
NCT01932437 is a clinical study titled "Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers". This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers
What is the current status of trial NCT01932437?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-07-26. Estimated completion is 2014-07-03.
What conditions does trial NCT01932437 study?
This clinical trial studies the following conditions: Inhalational Anthrax.
What interventions are being tested in trial NCT01932437?
The interventions under investigation include: Placebo (OTHER), ETI-204 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01932437?
This trial is sponsored by Elusys Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01932437 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01932437'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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