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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 Preterm Infants, sponsored by Aerogen Pharma Limited.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 520
- Enrollment target
- 9
- Study locations
NCT06776783: Recruiting Phase 3 study of Respiratory Distress Syndrome and Preterm Infants, sponsored by Aerogen Pharma Limited.
NCT06776783 is a Phase 3 study of Respiratory Distress Syndrome and Preterm 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06776783, a Phase 3 study of Respiratory Distress Syndrome and Preterm 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.
Primary Outcome
Number (%) of subjects who meet the predetermined criteria for failure of nCPAP/NIV
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 |
What NCT06776783 shows while recruiting
NCT06776783 is an interventional study that assigns participants to a tested intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 8 other Respiratory Distress Syndrome trials with a reported enrollment target (208% higher).
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 lists 9 locations in 8 states (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, Preterm 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06776783's enrollment target sits among peer trials
520 2nd of 8 the highest of 8 other Respiratory Distress Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Distress Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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