Brief Title
Phase 1b/2 Study on AT-100 Intervention (rhSP-D) in Preterm Neonates at High Risk for Development of Bronchopulmonary Dysplasia (BPD)
Official Title
A Phase 1b/2, Randomized, Open-Label, Dose-Determined Study Evaluating the Safety, Tolerability, and Efficacy Profile of Intervention With AT-100 (rhSP-D) in Preterm Neonates at High Risk for the Development of Bronchopulmonary Dysplasia (BPD)
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 standard neonatal care alone.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Phase 1b: Determining the highest-tolerated & safety-tested AT-100 dose
Secondary Outcome
BPD or death
Condition
Bronchopulmonary Dysplasia
Intervention
AT-100
Study Arms / Comparison Groups
Phase 1b Open-Label AT-100 dose escalation
Description: Once daily AT-100 via intratracheal administration for up to 7 doses.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
270
Start Date
January 2021
Completion Date
December 2024
Primary Completion Date
February 2023
Eligibility Criteria
Inclusion Criteria 1. Preterm neonates born between 23 0/7 weeks to 28 6/7 weeks. 2. Intubated and on mechanical ventilation. 3. Receiving at least 1 dose of standard-of-care-indicated surfactant treatment (Curosurf®) within 24 hours of birth. 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). 5. History of allergy or sensitivity to any surfactant or any component of the Investigational Product (AT-100). 6. Birth mother has or had: 1. Known positive Hepatitis A, B, C, D or E diagnosis. 2. 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. Known Sexually Transmitted Infection (STI). 4. Known Cytomegalovirus (CMV) active infection. 5. History or evidence of alcohol or drug abuse. 7. Concurrent enrollment in an investigational drug, device, or treatment modulation trial. 8. 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. 9. Symptomatic and confirmed COVID-19 infection of the mother and/or neonate.
Gender
All
Ages
N/A - 24 Hours
Accepts Healthy Volunteers
No
Contacts
Paul S. Kingma, MD, PhD, 470-486-4688, [email protected]
Administrative Informations
NCT ID
NCT04662151
Organization ID
AT-100/001
Responsible Party
Sponsor
Study Sponsor
Airway Therapeutics, Inc.
Study Sponsor
Paul S. Kingma, MD, PhD, Study Director, Airway Therapeutics, Inc.
Verification Date
January 2021