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Trial record 2 of 878 for:    AT-100

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

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ClinicalTrials.gov Identifier: NCT04662151
Recruitment Status : Not yet recruiting
First Posted : December 10, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Airway Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 4, 2020
First Posted Date  ICMJE December 10, 2020
Last Update Posted Date April 1, 2021
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2021)
Safety and tolerability of AT-100 [ Time Frame: From time of initial AT-100 dosing until end of the study participation up to 36 Weeks Postmenstrual Age (PMA) ]
Dose escalation of AT-100 up to the highest tolerated and safety tested dose level in order to assess safety and tolerability.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • Phase 1b: Determining the highest-tolerated & safety-tested AT-100 dose [ Time Frame: From time of initial AT-100 dosing until end of the dosing period, up to 7 days ]
    Dose escalation of AT-100 up to the maximum feasible dose in order to assess safety and tolerability
  • Phase 2: Reduction in time on mechanical ventilation [ Time Frame: From birth to 36 Weeks Postmenstrual Age (PMA) ]
    Days on mechanical ventilation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2021)
  • BPD or death [ Time Frame: At 36 Weeks PMA ]
    Incidence of BPD or death.
  • Time on mechanical ventilation [ Time Frame: From birth to 36 Weeks PMA ]
    Time (days) on mechanical ventilation.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • BPD or death [ Time Frame: At 36 Weeks PMA ]
    Incidence of BPD or death.
  • Long term reduction in time on mechanical ventilation [ Time Frame: From birth to 1 year Corrected Age (CA) ]
    Days on mechanical ventilation.
  • Long term reduction in time on respiratory support [ Time Frame: From birth to 1 year Corrected Age (CA) ]
    Days on respiratory oxygen support.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1b Study on AT-100 Intervention (rhSP-D) in Preterm Neonates at High Risk for Development of Bronchopulmonary Dysplasia (BPD)
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Bronchopulmonary Dysplasia
Intervention  ICMJE
  • Biological: AT-100
    reconstituted AT-100 for intratracheal administration
    Other Name: (rhSP-D)
  • Procedure: Air-sham
    room air for intratracheal administration
Study Arms  ICMJE
  • Experimental: Phase 1b open-label AT-100
    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).
    Intervention: Biological: AT-100
  • Sham Comparator: Phase 1b open-label air-sham
    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: Procedure: Air-sham
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2021)
36
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2020)
270
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 24 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Neil P. Mills, BS 470-486-4688 mills@airwaytherapeutics.com
Contact: Paul S. Kingma, MD, PhD 513-770-9630 kingma@airwaytherapeutics.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04662151
Other Study ID Numbers  ICMJE AT-100/001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Airway Therapeutics, Inc.
Study Sponsor  ICMJE Airway Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul S. Kingma, MD, PhD Airway Therapeutics, Inc.
Study Chair: Marc O. Salzberg, MD Airway Therapeutics, Inc.
Principal Investigator: Brenda L Poindexter, MD, MS Emory University
PRS Account Airway Therapeutics, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP