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).
Latest Information Update: 22 Jul 2022
At a glance
- Drugs DMX 101 (Primary) ; DMX 101 (Primary)
- Indications Ectodermal dysplasia
- Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
- Sponsors Edimer Pharmaceuticals
- 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.