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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: Completed Phase 1 study, sponsored by Elusys Therapeutics.
NCT01453907 is a Phase 1 study that has completed, run by Elusys Therapeutics. The registered enrollment target is 108 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the safety of increasing doses of ETI-204 in healthy subjects
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 |
What the finished NCT01453907 record still lists
NCT01453907 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01453907 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01453907's enrollment target sits among peer trials
108 523rd of 2000 higher than 1,470 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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