NCT06776783

Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Aerogen Pharma Limited · Industry
• Sex: All
• Age: 1 Hour – 24 Hours
• Healthy volunteers: Not accepted

Summary

This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 24 months corrected age.

Conditions

• Respiratory Distress Syndrome
• Pre-term Infants

Interventions

Type	Name	Description
COMBINATION_PRODUCT	APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)	Subjects in the APC-0101 group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface and APC-0101 treatment will be started.
OTHER	Control	Subjects in the Control group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface but an empty vial will be used instead of APC-0101.

Timeline

• Start date: 2025-09-24
• Primary completion: 2027-05-01
• Completion: 2029-05-01
• First posted: 2025-01-15
• Last updated: 2026-04-14

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study