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Clinical trial

A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of APC-0101 (SF-RI 1 Surfactant for Inhalation Combined With a Dedicated Delivery System) in Preterm Infants With Respiratory Distress Syndrome

NCT06776783 is registered in ClinicalTrials.gov with Aerogen Pharma Limited as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of APC-0101 (SF-RI 1 Surfactant for Inhalation Combined With a Dedicated Delivery System) in Preterm Infants With Respiratory Distress Syndrome
Lead sponsor
Aerogen Pharma Limited
Phase
Phase 3
Overall status
Recruiting
Start date
September 24, 2025
Completion date
May 31, 2029
Enrollment
520 (estimated)
Sites
31

Conditions

As the registry lists them; a condition with its own page is linked.

pre-term infants, respiratory distress syndrome