Phase 1b/2 Study on AT-100 Intervention (rhSP-D) in Preterm Neonates at High Risk for Development of Bronchopulmonary Dysplasia (BPD)

Brief Title

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

Official Title

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)

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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Number of adverse events experienced by participants

Secondary Outcome

 Incidence of BPD or death

Condition

Bronchopulmonary Dysplasia

Intervention

AT-100

Study Arms / Comparison Groups

 Phase 1b open-label AT-100

Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

36

Start Date

September 1, 2021

Completion Date

March 2023

Primary Completion Date

March 2023

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - 96 Hours

Accepts Healthy Volunteers

No

Contacts

Marc O. Salzberg, MD, 470-486-4688, [email protected]

Location Countries

Spain

Location Countries

Spain

NCT ID

NCT04662151

Organization ID

AT-100/001

Responsible Party

Sponsor

Study Sponsor

Airway Therapeutics, Inc.

Study Sponsor

Marc O. Salzberg, MD, Study Chair, Airway Therapeutics, Inc.

Verification Date

April 2022