NCT04662151 is a Phase 1 clinical trial of AT-100 in Bronchopulmonary Dysplasia, sponsored by Airway Therapeutics, Inc..

Who is sponsoring NCT04662151?

NCT04662151 is sponsored by Airway Therapeutics, Inc..

What drugs are being tested in NCT04662151?

Interventions in NCT04662151: AT-100, Air-sham.

What condition does NCT04662151 study?

NCT04662151 studies Bronchopulmonary Dysplasia.

Is NCT04662151 still recruiting?

NCT04662151 is currently completed. Last updated 3 July 2024.

Last reviewed 2024-07-03 · How we verify

NCT04662151

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 3 July 2024

What this trial tests

Phase 1 trial testing AT-100 in Bronchopulmonary Dysplasia in 37 participants. Completed in 29 May 2024.

Timeline

1 September 2021

Primary endpoint
14 August 2023

29 May 2024

Quick facts

Lead sponsor	Airway Therapeutics, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	37
Start date	1 September 2021
Primary completion	14 August 2023
Estimated completion	29 May 2024
Sites	19 locations across United States, Spain

Drugs / interventions tested

AT-100 — full drug profile →
Air-sham

Conditions studied

Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →

Sponsor

Airway Therapeutics, Inc. — full company profile →

Who can join

Adults 0 Minutes to 96 Hours, any sex, with Bronchopulmonary Dysplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmacotherapy in Bronchopulmonary Dysplasia: What Is the Evidence?
Sakaria RP, Dhanireddy R. · · 2022 · cited 17× · PMID 35356441 · DOI 10.3389/fped.2022.820259
Humoral Immunity Against Aspergillus fumigatus.
Dellière S, Aimanianda V. · · 2023 · cited 9× · PMID 37289362 · DOI 10.1007/s11046-023-00742-0
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.
Alonso-Ojembarrena A, Poindexter B, Aleem S, Healy H, et al · · 2025 · cited 1× · PMID 41018057 · DOI 10.3389/fped.2025.1639573

Verify or expand the search:

Other trials of AT-100

Trials testing the same drug.

NCT04659122 — A Clinical Safety Study on AT-100 in Treating Adults With Severe COVID-19 Infection or Severed Community Acquired Pneumo · Phase 1 · terminated

Other recruiting trials for Bronchopulmonary Dysplasia

Currently open trials in the same condition.

NCT06589245 — Inhaled Ciclesonide Study in Preterm Infants · Phase 1 · recruiting
NCT06512935 — Ventilator Pressure and Optimization of Compliance and Hemodynamics · NA · recruiting
NCT06534359 — Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia · NA · recruiting
NCT06808997 — Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preter · recruiting
NCT06897839 — Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD) · Phase 2, PHASE3 · recruiting

Other Airway Therapeutics, Inc. trials

Trials by the same sponsor.

NCT06897839 — Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD) · Phase 2, PHASE3 · recruiting
NCT04659122 — A Clinical Safety Study on AT-100 in Treating Adults With Severe COVID-19 Infection or Severed Community Acquired Pneumo · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04662151 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Airway Therapeutics, Inc.
Last refreshed: 3 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04662151.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing