MedTrace Logo

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

NCT06776783 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2026-04-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Aerogen Pharma Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-24
Primary Completion
2027-05-31
Completion
2029-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06776783 on ClinicalTrials.gov