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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: Completed Phase 1 study, sponsored by Edimer Pharmaceuticals.

NCT01564225 is a Phase 1 study that has completed, run by Edimer Pharmaceuticals. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 6 participants
Start Date 2012-05
Est. Completion 2013-04
Phase Phase 1
Edimer Pharmaceuticals

11 total trials

What the finished NCT01564225 record still lists

NCT01564225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which EDI200 is the first listed.

NCT01564225 does not publish any study locations in the registry export this page uses.

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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How this trial's enrollment target compares

Where NCT01564225's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 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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Source: ClinicalTrials.gov NCT01564225, the US trial registry maintained by the National Library of Medicine. NCT01564225 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.