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NCT06776783 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
A Phase 3 study of Respiratory Distress Syndrome and Pre-term Infants, sponsored by Aerogen Pharma Limited.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 520
- Enrollment target
- 9
- Study locations
NCT06776783 is a Phase 3 study of Respiratory Distress Syndrome and Pre-term Infants that is actively recruiting participants, run by Aerogen Pharma Limited. The registered enrollment target is 520 participants, above the 169-participant average among 8 other Respiratory Distress Syndrome trials with a reported enrollment target (208% higher). The trial reports 9 study locations across 8 states.
The verdict
NCT06776783, a Phase 3 study of Respiratory Distress Syndrome and Pre-term Infants, is actively recruiting participants, sponsored by Aerogen Pharma Limited.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 520 participants
- Enrollment target
- 9
- Study locations
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 Studied
Interventions
- OTHER Control
- COMBINATION_PRODUCT APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)
Study Locations (9)
Florida
- UF Health Jacksonville - Jacksonville
- Advent Health - Orlando
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Indiana
- Memorial Hospital of South Bend - South Bend
New Jersey
- Goryeb Children's Hospital - Morristown
New York
- Montefiore Medical Center - The Bronx
Texas
- Christus Children's Hospital - San Antonio
Virginia
- University of Virginia School of Medicine - Charlottesville
West Virginia
- WVU Medicine Children's Hospital - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 520 participants |
| Start Date | 2025-09-24 |
| Est. Completion | 2029-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06776783
The ClinicalTrials.gov registry entry for NCT06776783 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 169-participant average among 8 other Respiratory Distress Syndrome trials with a reported enrollment target (208% higher). The listed sponsor is Aerogen Pharma Limited, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT06776783 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Florida, Arkansas, Indiana.
Frequently Asked Questions
What is clinical trial NCT06776783 about?
NCT06776783 is a clinical study titled "Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome". 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 (...
What is the current status of trial NCT06776783?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 520 participants. The study started on 2025-09-24. Estimated completion is 2029-05.
What conditions does trial NCT06776783 study?
This clinical trial studies the following conditions: Respiratory Distress Syndrome, Pre-term Infants.
What interventions are being tested in trial NCT06776783?
The interventions under investigation include: Control (OTHER), APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06776783?
This trial is sponsored by Aerogen Pharma Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06776783 being conducted?
This trial has 9 study locations across Arkansas, Florida, Indiana, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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