NCT04662151

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Airway Therapeutics, Inc. · Industry
• Sex: All
• Age: 0 Minutes – 96 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
BIOLOGICAL	AT-100	reconstituted AT-100 for intratracheal administration
PROCEDURE	Air-sham	room air for intratracheal administration

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-08-14
• Completion: 2024-05-29
• First posted: 2020-12-10
• Last updated: 2024-07-03

Locations

19 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study