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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).

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 22 Jul 2022

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At a glance

  • Drugs DMX 101 (Primary) ; DMX 101 (Primary)
  • Indications Ectodermal dysplasia
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Edimer Pharmaceuticals
  • Most Recent Events

    • 06 Apr 2020 Results of first-in-human phase I study of Fc-EDA (NCT01564225) and a phase II trial in newborn infants (NCT01775462) assessing safety and immunogenicity of Fc-EDA, published in the British Journal of Clinical Pharmacology
    • 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.
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