Purpose

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.

Condition

Eligibility

Eligible Ages
Between 0 Minutes and 96 Hours
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Phase 1b portion is a randomized, dual-armed, dose escalation study to establish the safest & most tolerated AT-100 dose tested as compared to air-sham alone.
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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).
  • Biological: AT-100
    reconstituted AT-100 for intratracheal administration
    Other names:
    • (rhSP-D)
Sham Comparator
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).
  • Procedure: Air-sham
    room air for intratracheal administration

Recruiting Locations

Airway Therapeutics Investigational Site
Tucson, Arizona 85724

Airway Therapeutics Investigational Site
Los Angeles, California 90017

Airway Therapeutics Investigational Site
Orange, California 92868

Airway Therapeutics Investigational Site
Atlanta, Georgia 30308

Airway Therapeutics Investigational Site
Boston, Massachusetts 02215

Airway Therapeutics Investigational Site
Durham, North Carolina 27705

Airway Therapeutics Investigational Site
Nashville, Tennessee 37232

Airway Therapeutics Investigational Site
Norfolk, Virginia 23507

More Details

NCT ID
NCT04662151
Status
Recruiting
Sponsor
Airway Therapeutics, Inc.

Study Contact

Neil P. Mills, BS
470-486-4688
mills@airwaytherapeutics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.