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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04662151
• Other study ID #: AT-100/001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 1, 2021
• Est. completion date: May 23, 2024

Study information

• Verified date: August 2023
• Source: Airway Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: May 23, 2024
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Minutes to 96 Hours

Eligibility

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.

2. Has a known illness or exposure that, in the judgement of the Investigator, is serious enough to induce an immune deficiency such as Human Immunodeficiency Virus (HIV) and/or is receiving chemotherapy.

3. Has known active Sexually Transmitted Infection (STI).

4. Has known Cytomegalovirus (CMV) active infection.

5. Has known history or evidence of alcohol or drug abuse, wit the exception of marijuana/marijuana-based products/THC, based on a positive maternal or infant drug screen as evidenced by the institution's standard-of-care practice.

9. Concurrent enrollment in an investigational drug, device, or treatment modulation trial that utilizes treatments outside of standard-of-care.

10. Any condition or situation which, in the Investigator's judgement, puts the mother or the neonate at significant risk, could confound the trial results, or may interfere significantly with the mother's or neonate's participation in the trial.

11. Symptomatic and confirmed COVID-19 infection of the mother around the time of birth.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

Intervention

Biological:
• AT-100
reconstituted AT-100 for intratracheal administration

Procedure:
• Air-sham
room air for intratracheal administration

Locations

Country	Name	City	State
Spain	Airway Therapeutics Investigational Site	A Coruña
Spain	Airway Therapeutics Investigational Site	Alicante	Comunidad Valenciana
Spain	Airway Therapeutics Investigational Site	Barcelona	Cataluña
Spain	Airway Therapeutics Investigational Site	Cadiz	Andalucia
Spain	Airway Therapeutics Investigational Site	Lleida
Spain	Airway Therapeutics Investigational Site	Madrid	Comunidad De Madrid
Spain	Airway Therapeutics Investigational Site	Madrid	Comunidad De Madrid
Spain	Airway Therapeutics Investigational Site	Málaga
Spain	Airway Therapeutics Investigational Site	Santiago De Compostela	Galicia
Spain	Airway Therapeutics Investigational Site	Valencia	Comunidad Valenciana
United States	Airway Therapeutics Investigational Site	Atlanta	Georgia
United States	Airway Therapeutics Investigational Site	Boston	Massachusetts
United States	Airway Therapeutics Investigational Site	Durham	North Carolina
United States	Airway Therapeutics Investigational Site	Indianapolis	Indiana
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	Norfolk	Virginia
United States	Airway Therapeutics Investigational Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Airway Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Spain, 

References & Publications (5)

Ikegami M, Carter K, Bishop K, Yadav A, Masterjohn E, Brondyk W, Scheule RK, Whitsett JA. Intratracheal recombinant surfactant protein d prevents endotoxin shock in the newborn preterm lamb. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1342-7. doi: 10.1164/rccm.200509-1485OC. Epub 2006 Mar 23. — View Citation

Jensen EA, Dysart K, Gantz MG, McDonald S, Bamat NA, Keszler M, Kirpalani H, Laughon MM, Poindexter BB, Duncan AF, Yoder BA, Eichenwald EC, DeMauro SB. The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach. Am J Respir Crit Care Med. 2019 Sep 15;200(6):751-759. doi: 10.1164/rccm.201812-2348OC. — View Citation

Sato A, Whitsett JA, Scheule RK, Ikegami M. Surfactant protein-d inhibits lung inflammation caused by ventilation in premature newborn lambs. Am J Respir Crit Care Med. 2010 May 15;181(10):1098-105. doi: 10.1164/rccm.200912-1818OC. Epub 2010 Feb 4. — View Citation

Sorensen GL. Surfactant Protein D in Respiratory and Non-Respiratory Diseases. Front Med (Lausanne). 2018 Feb 8;5:18. doi: 10.3389/fmed.2018.00018. eCollection 2018. — View Citation

Thebaud B, Goss KN, Laughon M, Whitsett JA, Abman SH, Steinhorn RH, Aschner JL, Davis PG, McGrath-Morrow SA, Soll RF, Jobe AH. Bronchopulmonary dysplasia. Nat Rev Dis Primers. 2019 Nov 14;5(1):78. doi: 10.1038/s41572-019-0127-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events	Incidence and severity of adverse events between the two treatment groups will be compared	Adverse events will be followed up to Day 28 of life
Primary	Incidence of BPD or death		Week 36 PMA

External Links

•   Airway Therapeutics' corporate website