A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)
NCT ID: NCT04662151
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2021-09-01
2024-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Phase 1b open-label AT-100
Once daily AT-100 via intratracheal administration for up to 2 doses (initial Phase 1b dose-escalation portion) or 7 doses (latter Phase 1b highest tolerated \& safety dose level tested portion).
AT-100
reconstituted AT-100 for intratracheal administration
Phase 1b open-label air-sham
Once daily air-sham via intratracheal administration for up to 2 doses (initial Phase 1b dose-escalation portion) or 7 doses (latter Phase 1b highest tolerated \& safety dose level tested portion).
Air-sham
room air for intratracheal administration
Interventions
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AT-100
reconstituted AT-100 for intratracheal administration
Air-sham
room air for intratracheal administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
0 Minutes
96 Hours
ALL
No
Sponsors
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Airway Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marc O. Salzberg, MD
Role: STUDY_CHAIR
Airway Therapeutics, Inc.
Locations
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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
Airway Therapeutics Investigational Site
Barcelona, Catalonia, Spain
Airway Therapeutics Investigational Site
Santiago de Compostela, Galicia, Spain
Airway Therapeutics Investigational Site
Madrid, Madrid, Spain
Airway Therapeutics Investigational Site
Madrid, Madrid, Spain
Airway Therapeutics Investigational Site
Alicante, Valencia, Spain
Airway Therapeutics Investigational Site
Valencia, Valencia, Spain
Airway Therapeutics Investigational Site
A Coruña, , Spain
Airway Therapeutics Investigational Site
Lleida, , Spain
Airway Therapeutics Investigational Site
Málaga, , Spain
Countries
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References
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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.
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.
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.
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.
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.
Alonso-Ojembarrena A, Poindexter B, Aleem S, Healy H, Aguar-Carrascosa M, Moliner-Calderon E, Serrano-Martin MDM, Arroyo R, Vento M. A phase 1b randomized, multicenter, dose determination trial of zelpultide alfa (recombinant human surfactant protein D) in preterm neonates at high risk of developing bronchopulmonary dysplasia. Front Pediatr. 2025 Sep 12;13:1639573. doi: 10.3389/fped.2025.1639573. eCollection 2025.
Related Links
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Airway Therapeutics' corporate website
Other Identifiers
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AT-100/001
Identifier Type: -
Identifier Source: org_study_id
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