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A First in Human Clinical Study on the Safety and Tolerability of Two Escalating Single Doses of CHF 5633 (Synthetic Surfactant) in Preterm Neonates With Respiratory Distress Syndrome

Trial Profile

A First in Human Clinical Study on the Safety and Tolerability of Two Escalating Single Doses of CHF 5633 (Synthetic Surfactant) in Preterm Neonates With Respiratory Distress Syndrome

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Nov 2017

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At a glance

  • Drugs Elifactant (Primary)
  • Indications Neonatal respiratory distress syndrome
  • Focus Adverse reactions; First in man
  • Sponsors Chiesi Farmaceutici
  • Most Recent Events

    • 01 Nov 2017 Results assessing safety and tolerability of CHF5633 and exploring preliminary efficacy published in the Archives of Disease in Childhood. Fetal and Neonatal Edition
    • 08 Feb 2015 Status changed from recruiting to completed according to ClinicalTrials.gov record.
    • 30 May 2014 New trial record
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