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

Brief Title

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

Official Title

A Phase 1b, Randomized, Open-Label, 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

Safety and tolerability of AT-100

Secondary Outcome

 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

April 2021

Completion Date

February 2022

Primary Completion Date

December 2021

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]

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

March 2021