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

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.

Timeline

Start

2025-09-24

Primary completion

2027-05

Completion

2029-05

Drugs

Indications