A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)
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
- Bronchopulmonary Dysplasia
Eligibility
- Eligible Ages
- Between 0 Minutes and 96 Hours
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Arm | Description | Assigned 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). |
|
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). |
|
Recruiting Locations
Airway Therapeutics Investigational Site
Tucson, Arizona 85724
Tucson, Arizona 85724
Airway Therapeutics Investigational Site
Little Rock, Arkansas 72202
Little Rock, Arkansas 72202
Airway Therapeutics Investigational Site
Los Angeles, California 90017
Los Angeles, California 90017
Airway Therapeutics Investigational Site
Miami, Florida 33143
Miami, Florida 33143
Airway Therapeutics Investigational Site
Atlanta, Georgia 30308
Atlanta, Georgia 30308
Airway Therapeutics Investigational Site
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Airway Therapeutics Investigational Site
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Airway Therapeutics Investigational Site
Durham, North Carolina 27705
Durham, North Carolina 27705
Airway Therapeutics Investigational Site
Norfolk, Virginia 23507
Norfolk, Virginia 23507
More Details
- NCT ID
- NCT04662151
- Status
- Recruiting
- Sponsor
- Airway Therapeutics, Inc.