NCT01651637View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

January 23, 2015

Study Completion Date

January 23, 2015

Conditions
Respiratory Distress Syndrome in Premature Infants
Interventions
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

Trial Locations (1)

Unknown

Liverpool Women's Hospital Neonatal Unit Liverpool Women's Hospital, Liverpool

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY

NCT01651637 - First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome | Biotech Hunter | Biotech Hunter