NCT06776783 - Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome | Biotech Hunter

Enrollment

520

Participants

Timeline

Start Date

September 24, 2025

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2029

Conditions

Respiratory Distress SyndromePre-term Infants

Interventions

COMBINATION_PRODUCT

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

Subjects in the APC-0101 group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface and APC-0101 treatment will be started.

OTHER

Control

Subjects in the Control group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface but an empty vial will be used instead of APC-0101.

Trial Locations (1)

10461

RECRUITING

Montefiore Medical Center, The Bronx