A Phase 2 open-label, dose-escalation study to evaluate the safety, pharmacokinetics, immunogeniticy and pharmacodynamics/efficacy of EDI200, an EDA-A1 replacement protein, administered to male infants with X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED).

Trial Profile

A Phase 2 open-label, dose-escalation study to evaluate the safety, pharmacokinetics, immunogeniticy and pharmacodynamics/efficacy of EDI200, an EDA-A1 replacement protein, administered to male infants with X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED).

Completed
Phase of Trial: Phase II

Latest Information Update: 04 May 2016

At a glance

  • Drugs EDI 200 (Primary)
  • Indications Ectodermal dysplasia
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Edimer Pharmaceuticals
  • Most Recent Events

    • 19 Jan 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 04 Sep 2015 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
    • 07 May 2015 Planned End Date changed from 1 Oct 2014 to 1 Dec 2015 as reported by ClinicalTrials.gov.
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