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NCT00829582 · ClinicalTrials.gov registry record · Phase 1
Intravenous Dose-Escalation Study With ETI-204 in Adult Volunteers
A Phase 1 study, sponsored by Elusys Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT00829582 is a Phase 1 study that has completed, run by Elusys Therapeutics. The registered enrollment target is 45 participants.
The verdict
NCT00829582, a Phase 1 study, has completed, sponsored by Elusys Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
Title: Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Phase I Study of the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Dose of ETI-204 (AnthimTM) Population: This study will determine the safety, tolerability and pharmacokinetics of a single iv dose of ETI-204 in subjects 18 to 50 years of age. Three cohorts will be studied sequentially: subjects receiving 120 mg, 240 mg and 360 mg of ETI-204. The study will be randomized, double-blind, and stratified by gender. Each cohort will contain 15 subjects (including at least four females), twelve who will receive ETI-204 and three who will receive placebo. Study Objectives: To determine the safety, tolerability and pharmacokinetics of ETI-204 following a single intravenous administration.
Interventions
- OTHER placebo
- DRUG ETI-204, "Anthim"
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00829582
The ClinicalTrials.gov registry entry for NCT00829582 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 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.
NCT00829582 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00829582 about?
NCT00829582 is a clinical study titled "Intravenous Dose-Escalation Study With ETI-204 in Adult Volunteers". Title: Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Phase I Study of the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Dose of ETI-204 (AnthimTM) Population: This study will determine the safety, tolerability and pharmacokinetics of a single iv dose of ETI-204 i...
What is the current status of trial NCT00829582?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2009-02. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00829582?
The interventions under investigation include: placebo (OTHER), ETI-204, "Anthim" (DRUG).
Who is sponsoring clinical trial NCT00829582?
This trial is sponsored by Elusys Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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