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NCT00744146 · ClinicalTrials.gov registry record · Phase 1
First Time in Human Study of Protexia
A Phase 1 study, sponsored by PharmAthene.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT00744146 is a Phase 1 study that has completed, run by PharmAthene. The registered enrollment target is 33 participants.
The verdict
NCT00744146, a Phase 1 study, has completed, sponsored by PharmAthene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of Protexia, an experimental drug being developed to protect soldiers against the effects of nerve agents. Volunteers will be entered into one of five groups. Four of the groups will receive a single intramuscular dose of Protexia or saline placebo on Study Day 1 and will participate in the study for approximately 71 days. One of the groups will receive two intramuscular doses of Protexia or saline placebo - one dose on Study Day 1 and the second dose on Study Day 72. This group will participate in the study for approximately 142 days. All volunteers will remain at the study site as an inpatient for three days after they are dosed and will be monitored closely by the study doctors and staff. After that, volunteers will return to the study site as outpatients at predetermined intervals. Groups 1, 2, 4, 5 will have a total of 6 follow-up visits and Group 3 will have a total of 12 follow-up visits. It is expected that this study will provide important information on the safety and tolerabiity of Protexia at one and two doses.
Interventions
- BIOLOGICAL Protexia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00744146
The ClinicalTrials.gov registry entry for NCT00744146 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PharmAthene, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Protexia is the first listed.
NCT00744146 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00744146 about?
NCT00744146 is a clinical study titled "First Time in Human Study of Protexia". The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of Protexia, an experimental drug being developed to protect soldiers against the effects of nerve agents. Volunteers will be entered into one of five groups. Four of the groups will receive a sin...
What is the current status of trial NCT00744146?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2008-09. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00744146?
The interventions under investigation include: Protexia (BIOLOGICAL).
Who is sponsoring clinical trial NCT00744146?
This trial is sponsored by PharmAthene, which has 4 total clinical trials registered on ClinicalTrials.gov.
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