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Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
NCT06776783 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aerogen Pharma Limited, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06776783 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Florida, Arkansas, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06776783?
This trial is sponsored by Aerogen Pharma Limited, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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