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

Phase 1

Completed

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Procedure: Air-sham; Biological: AT-100

• Registration Number: NCT04662151
• Lead Sponsor: Airway Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-10
• Study Start: 2021-09-01
• Primary Completion: 2023-08-14
• Study Completion: 2024-05-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1b open-label air-sham	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).
Phase 1b open-label AT-100	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).

Primary Outcome Measures

Name	Time	Method
Incidence of BPD or death	Week 36 PMA
Number of participants with treatment-related adverse events	Adverse events will be followed up to Day 28 of life	Incidence and severity of adverse events between the two treatment groups will be compared

Trial Locations

Locations (1)

Airway Therapeutics Investigational Site; 🇪🇸 Málaga, Spain