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NCT01453907 · ClinicalTrials.gov registry record · Phase 1
Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers
A Phase 1 study, sponsored by Elusys Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
NCT01453907 is a Phase 1 study that has completed, run by Elusys Therapeutics. The registered enrollment target is 108 participants.
The verdict
NCT01453907, a Phase 1 study, has completed, sponsored by Elusys Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
Study Summary
This study will determine the safety and PK of a single IV dose of ETI-204 in subjects 18 to 65 years of age. Three cohorts will be studied with subjects receiving ETI-204. This study will be randomized, double-blind and stratified by gender. Each cohort will contain 36 subjects (including at least four females), 30 who will receive ETI-204 and six who will receive placebo.
Interventions
- DRUG placebo
- DRUG ETI-204, "Anthim"
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01453907
The ClinicalTrials.gov registry entry for NCT01453907 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Elusys Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01453907 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01453907 about?
NCT01453907 is a clinical study titled "Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers". This study will determine the safety and PK of a single IV dose of ETI-204 in subjects 18 to 65 years of age. Three cohorts will be studied with subjects receiving ETI-204. This study will be randomized, double-blind and stratified by gender. Each cohort will contain 36 subjects (including at least ...
What is the current status of trial NCT01453907?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2011-10. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01453907?
The interventions under investigation include: placebo (DRUG), ETI-204, "Anthim" (DRUG).
Who is sponsoring clinical trial NCT01453907?
This trial is sponsored by Elusys Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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