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

ClinicalTrials.gov ID: NCT06776783

Public ClinicalTrials.gov record NCT06776783. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 21, 2026, 1:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of APC-0101 (SF-RI 1 Surfactant for Inhalation Combined With a Dedicated Delivery System) in Preterm Infants With Respiratory Distress Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06776783
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Aerogen Pharma Limited; Industry
Enrollment: 520 participants

Conditions and interventions

Conditions

Interventions

APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system) Combination Product
Control Other

Combination Product · Other

Eligibility (public fields only)

Age range: 1 Hour to 24 Hours
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 24, 2025 (Actual)
Primary completion: May 2027 (Estimated)
Completion: May 2029 (Estimated)
Last update posted: Oct 13, 2026

2025 – 2029

United States locations

U.S. sites: 18
U.S. states: 12
U.S. cities: 17

Facility	City	State	ZIP	Site status
University of Arkansas for Medical Sciences	Little Rock	Arkansas	72205	Recruiting
Jacobs Medical Center	La Jolla	California	92037	Recruiting
University of California Davis Children's Hospital	Sacramento	California	95817	Recruiting
Sharp Mary Birch Hospital for Women & Newborns	San Diego	California	92123	Recruiting
UF Health Jacksonville	Jacksonville	Florida	32209	Recruiting
Advent Health	Orlando	Florida	32803	Recruiting
Memorial Hospital of South Bend	South Bend	Indiana	46601	Recruiting
University of Maryland Children's Hospital	Baltimore	Maryland	21201	Recruiting
Tufts Medical Center	Boston	Massachusetts	02111	Recruiting
Goryeb Children's Hospital	Morristown	New Jersey	07960	Recruiting
Mount Sinai Hospital	New York	New York	10024	Recruiting
The Trustees of Columbia University in the City of New York	New York	New York	10032	Recruiting
Montefiore Medical Center	The Bronx	New York	10461	Recruiting
Maria Farreri Children's Hospital	Valhalla	New York	10595	Recruiting
University of Pittsburgh Medical Center Magee Women's Hospital	Pittsburgh	Pennsylvania	15213	Recruiting
Christus Children's Hospital	San Antonio	Texas	78207	Recruiting
University of Virginia Children's Hospital	Charlottesville	Virginia	22903	Recruiting
WVU Medicine Children's Hospital	Morgantown	West Virginia	26506	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06776783, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 13, 2026 · Synced Oct 21, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06776783 live on ClinicalTrials.gov.

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