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COMPLETEDPHASE1

A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)

A Phase 1b, Randomized, Blinded, Dose-Determined Study Evaluating the Safety and Tolerability Profile of Intervention With AT-100 (rhSP-D) in Preterm Neonates at High Risk for the Development of Bronchopulmonary Dysplasia (BPD)

NCT04662151•Airway Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham alone.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Preterm neonates born between Gestional Age (GA):
•1. 25 0/7 weeks to 28 6/7 weeks in the initial dose escalation cohorts.
•2. 23 0/7 weeks to 28 6/7 weeks in the latter cohort.
•2. Intubated and on mechanical ventilation.
•3. Receiving at least 1 dose of standard-of-care-indicated surfactant treatment (Curosurf®) after birth, and able to receive the first dose of AT-100 or air-sham within 96 hours of birth given at any time point after 15 minutes following any of the subject's Curosurf® dose(s).
•4. Parent or legal guardian is able to provide informed consent.

Exclusion Criteria

•1. Weight at time of birth \< 400 g or \> 1,800 g.
•2. Major apparent congenital abnormalities impacting cardio and pulmonary function.
•3. Active DNR (Do Not Resuscitate) order in place.
•4. Known pulmonary air leaks (e.g. pneumothorax and pneumomediastinum) at the time of AT-100 or air-sham administration.
•5. History of allergy or sensitivity to any surfactant or any component of the Investigational Product (AT-100).
•6. AT-100 or air-sham dosing was set to occur before Data Safety Monitoring Committee recommendation to proceed to the next dose-escalation cohort.
•7. Use of minimally invasive surfactant techniques (e.g., LISA, MIST) or INSURE or if, in the opinion of the care team, the infant is very likely too be extubated shortly after receiving Curosurf®.
•a. Subjects extubated and re-intubated after their Curosurf® dose(s) are eligible, so long as the subject meets Inclusion #3.
•8. Birth mother:
•1. Has known active Hepatitis B, C, or E diagnosis.
+7 more criteria

Locations (19)

Airway Therapeutics Investigational Site

Tucson, Arizona, United States

Airway Therapeutics Investigational Site

Little Rock, Arkansas, United States

Airway Therapeutics Investigational Site

Los Angeles, California, United States

Airway Therapeutics Investigational Site

Miami, Florida, United States

Airway Therapeutics Investigational Site

Atlanta, Georgia, United States

Airway Therapeutics Investigational Site

Indianapolis, Indiana, United States

Airway Therapeutics Investigational Site

Boston, Massachusetts, United States

Airway Therapeutics Investigational Site

Durham, North Carolina, United States

Airway Therapeutics Investigational Site

Norfolk, Virginia, United States

Airway Therapeutics Investigational Site

Cadiz, Andalusia, Spain

Key Dates

Start Date

September 1, 2021

Primary Completion Date

August 14, 2023

Completion Date

May 29, 2024

Last Updated

July 3, 2024

Enrollment

37

ACTUAL participants

Conditions

Bronchopulmonary Dysplasia

Interventions

AT-100

BIOLOGICAL

Air-sham

PROCEDURE

Sponsors

Lead Sponsor

Airway Therapeutics, Inc.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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