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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)

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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)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Jul 2024

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At a glance

  • Drugs Zelpultide alfa (Primary)
  • Indications Bronchopulmonary dysplasia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Airway Therapeutics

    • Most Recent Events

    • 03 Jul 2024 Status changed from active, no longer recruiting to completed.
    • 22 May 2024 Results determining the safety and tolerability profile of intervention with zelpultide alfa as compared to standard-of-care plus air-sham in preterm neonates at risk for the development of BPD, presented at the 120th International Conference of the American Thoracic Society
    • 05 Jun 2023 According to an Airway Therapeutics media release, last of 12 patients recruited into the fourth and final cohort of the study has been treated. The fourth cohort began recruitment March 28, 2023, following a Data Safety Monitoring Committee (DSMC) report finding no safety concerns at the conclusion of the trial's dose escalation portion, and included the extremely preterm neonates born as early as weeks 23 and 24.

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