NCT01651637

First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome

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: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 27 Weeks – 34 Weeks
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the safety and tolerability of intratracheal administration of two different single doses of CHF 5633 in preterm neonates with RDS in terms of adverse events, adverse drug reactions, hematology and biochemistry values, the incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and mortality.

Detailed description

The study will be a multicentre, open-label, single escalating dose, per-cohort design.

Conditions

• Respiratory Distress Syndrome in Premature Infants

Interventions

Type	Name	Description
DRUG	synthetic surfactant (CHF5633)	CHF5633 100 mg/kg; CHF5633 200 mg/kg synthetic surfactant sterile suspension in 3.0 ml glass vials with a total concentration of 80 mg/ml for intratracheal administration. Single administration

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-01-23
• Completion: 2015-01-23
• First posted: 2012-07-27
• Last updated: 2020-07-31

Locations

1 site across 1 country: United Kingdom