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

Primary Purpose

Bronchopulmonary Dysplasia

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AT-100
Air-sham
Sponsored by
Airway Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring Bronchopulmonary Dysplasia, Preterm, Neonate, Mechanical ventilation, Respiratory support, recombinant human Surfactant Protein-D (rhSP-D), intratracheal, air-sham

Eligibility Criteria

0 Minutes - 96 Hours (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site
  • Airway Therapeutics Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Phase 1b open-label AT-100

Phase 1b open-label air-sham

Arm 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).

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).

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events
Incidence and severity of adverse events between the two treatment groups will be compared
Incidence of BPD or death

Secondary Outcome Measures

Full Information

First Posted
December 4, 2020
Last Updated
September 5, 2023
Sponsor
Airway Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04662151
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 14, 2023 (Actual)
Study Completion Date
May 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Airway Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Bronchopulmonary Dysplasia, Preterm, Neonate, Mechanical ventilation, Respiratory support, recombinant human Surfactant Protein-D (rhSP-D), intratracheal, air-sham

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1b open-label AT-100
Arm Type
Experimental
Arm 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).
Arm Title
Phase 1b open-label air-sham
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
AT-100
Other Intervention Name(s)
(rhSP-D)
Intervention Description
reconstituted AT-100 for intratracheal administration
Intervention Type
Procedure
Intervention Name(s)
Air-sham
Intervention Description
room air for intratracheal administration
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Description
Incidence and severity of adverse events between the two treatment groups will be compared
Time Frame
Adverse events will be followed up to Day 28 of life
Title
Incidence of BPD or death
Time Frame
Week 36 PMA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Minutes
Maximum Age & Unit of Time
96 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Preterm neonates born between Gestional Age (GA): 25 0/7 weeks to 28 6/7 weeks in the initial dose escalation cohorts. 23 0/7 weeks to 28 6/7 weeks in the latter cohort. Intubated and on mechanical ventilation. 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). Parent or legal guardian is able to provide informed consent. Exclusion Criteria: Weight at time of birth < 400 g or > 1,800 g. Major apparent congenital abnormalities impacting cardio and pulmonary function. Active DNR (Do Not Resuscitate) order in place. Known pulmonary air leaks (e.g. pneumothorax and pneumomediastinum) at the time of AT-100 or air-sham administration. History of allergy or sensitivity to any surfactant or any component of the Investigational Product (AT-100). AT-100 or air-sham dosing was set to occur before Data Safety Monitoring Committee recommendation to proceed to the next dose-escalation cohort. 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. Birth mother: Has known active Hepatitis B, C, or E diagnosis. 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. Has known active Sexually Transmitted Infection (STI). Has known Cytomegalovirus (CMV) active infection. 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. Concurrent enrollment in an investigational drug, device, or treatment modulation trial that utilizes treatments outside of standard-of-care. 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. Symptomatic and confirmed COVID-19 infection of the mother around the time of birth.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc O. Salzberg, MD
Organizational Affiliation
Airway Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Airway Therapeutics Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Airway Therapeutics Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Airway Therapeutics Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Airway Therapeutics Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Airway Therapeutics Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Airway Therapeutics Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Airway Therapeutics Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Airway Therapeutics Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Airway Therapeutics Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Airway Therapeutics Investigational Site
City
Cadiz
State/Province
Andalucia
ZIP/Postal Code
11009
Country
Spain
Facility Name
Airway Therapeutics Investigational Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08041
Country
Spain
Facility Name
Airway Therapeutics Investigational Site
City
Madrid
State/Province
Comunidad De Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Airway Therapeutics Investigational Site
City
Madrid
State/Province
Comunidad De Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Airway Therapeutics Investigational Site
City
Alicante
State/Province
Comunidad Valenciana
ZIP/Postal Code
03010
Country
Spain
Facility Name
Airway Therapeutics Investigational Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Airway Therapeutics Investigational Site
City
Santiago De Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Airway Therapeutics Investigational Site
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Airway Therapeutics Investigational Site
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Airway Therapeutics Investigational Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31727986
Citation
Thebaud B, Goss KN, Laughon M, Whitsett JA, Abman SH, Steinhorn RH, Aschner JL, Davis PG, McGrath-Morrow SA, Soll RF, Jobe AH. Bronchopulmonary dysplasia. Nat Rev Dis Primers. 2019 Nov 14;5(1):78. doi: 10.1038/s41572-019-0127-7.
Results Reference
background
PubMed Identifier
30995069
Citation
Jensen EA, Dysart K, Gantz MG, McDonald S, Bamat NA, Keszler M, Kirpalani H, Laughon MM, Poindexter BB, Duncan AF, Yoder BA, Eichenwald EC, DeMauro SB. The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach. Am J Respir Crit Care Med. 2019 Sep 15;200(6):751-759. doi: 10.1164/rccm.201812-2348OC.
Results Reference
background
PubMed Identifier
29473039
Citation
Sorensen GL. Surfactant Protein D in Respiratory and Non-Respiratory Diseases. Front Med (Lausanne). 2018 Feb 8;5:18. doi: 10.3389/fmed.2018.00018. eCollection 2018.
Results Reference
background
PubMed Identifier
20133924
Citation
Sato A, Whitsett JA, Scheule RK, Ikegami M. Surfactant protein-d inhibits lung inflammation caused by ventilation in premature newborn lambs. Am J Respir Crit Care Med. 2010 May 15;181(10):1098-105. doi: 10.1164/rccm.200912-1818OC. Epub 2010 Feb 4.
Results Reference
background
PubMed Identifier
16556693
Citation
Ikegami M, Carter K, Bishop K, Yadav A, Masterjohn E, Brondyk W, Scheule RK, Whitsett JA. Intratracheal recombinant surfactant protein d prevents endotoxin shock in the newborn preterm lamb. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1342-7. doi: 10.1164/rccm.200509-1485OC. Epub 2006 Mar 23.
Results Reference
background
Links:
URL
http://www.airwaytherapeutics.com
Description
Airway Therapeutics' corporate website

Learn more about this trial

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

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