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/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 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]

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