← Eichor
Study identifier: NCT06776783 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Respiratory Distress Syndrome · Pre-term Infants  ·  Sponsor: Aerogen Pharma Limited

PhasePhase 3
Planned participants520
Who can joinAll sexes, 1 Hour to 24 Hours
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Shannon Strom  ·  9196026411  ·  sstrom@aerogenpharma.com

Always discuss trial participation with your own doctor first.

Locations (12)

University of Arkansas for Medical SciencesLittle Rock, Arkansas, United StatesRecruiting
Jacobs Medical CenterLa Jolla, California, United StatesRecruiting
UF Health JacksonvilleJacksonville, Florida, United StatesRecruiting
Advent HealthOrlando, Florida, United StatesRecruiting
Memorial Hospital of South BendSouth Bend, Indiana, United StatesRecruiting
Goryeb Children's HospitalMorristown, New Jersey, United StatesRecruiting
The Trustees of Columbia University in the City of New YorkNew York, New York, United StatesRecruiting
Montefiore Medical CenterThe Bronx, New York, United StatesRecruiting
Maria Farreri Children's HospitalValhalla, New York, United StatesRecruiting
Christus Children's HospitalSan Antonio, Texas, United StatesRecruiting
University of Virginia School of MedicineCharlottesville, Virginia, United StatesRecruiting
WVU Medicine Children's HospitalMorgantown, West Virginia, United StatesRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT06776783