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NCT01564225 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Open-label, Multicenter, Safety and Pharmacokinetic Study of EDI200
A Phase 1 study, sponsored by Edimer Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01564225 is a Phase 1 study that has completed, run by Edimer Pharmaceuticals. The registered enrollment target is 6 participants.
The verdict
NCT01564225, a Phase 1 study, has completed, sponsored by Edimer Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Following discussions with the FDA, a Phase 1 safety study is being initiated in X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)-affected adults to develop safety and exposure data for EDI200 in anticipation of dosing XLHED-affected neonates. Selecting XLHED-affected adults for this study provides a genetic match and biologic relevance to XLHED-affected neonates. Both males and females will be enrolled, providing safety experience with EDI200 that will inform the planned neonate study as well as supportive data for potential future trials of antenatal EDI200 administration.
Interventions
- DRUG EDI200
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01564225
The ClinicalTrials.gov registry entry for NCT01564225 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edimer Pharmaceuticals, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EDI200 is the first listed.
NCT01564225 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01564225 about?
NCT01564225 is a clinical study titled "A Phase 1, Open-label, Multicenter, Safety and Pharmacokinetic Study of EDI200". Following discussions with the FDA, a Phase 1 safety study is being initiated in X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)-affected adults to develop safety and exposure data for EDI200 in anticipation of dosing XLHED-affected neonates. Selecting XLHED-affected adults for this study provide...
What is the current status of trial NCT01564225?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2012-05. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01564225?
The interventions under investigation include: EDI200 (DRUG).
Who is sponsoring clinical trial NCT01564225?
This trial is sponsored by Edimer Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
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