Trial Profile
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:
Active, no longer recruiting
Phase of Trial:
Phase I
Latest Information Update: 08 Sep 2023
Price :
$35
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At a glance
- Drugs Zelpultide alfa (Primary)
- Indications Bronchopulmonary dysplasia
- Focus Adverse reactions; Therapeutic Use
- Sponsors Airway Therapeutics
- 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.
- 05 Jun 2023 According to an Airway Therapeutics media release, Interim analysis has been completed and full results are expected by October 2023.
- 05 Jun 2023 According to an Airway Therapeutics media release, company announced today it successfully completed enrollment in its Phase 1b trial of zelpultide alfa. A total of 37 infants were enrolled at 20 hospitals in the U.S. and Spain.