Phase 1b Study on AT-100 Intervention (rhSP-D) in Preterm Neonates at High Risk for Development of Bronchopulmonary Dysplasia (BPD)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 270
Summary
- Conditions
- Bronchopulmonary Dysplasia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Younger than 24 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04662151
- Collaborators
- Not Provided
- Investigators
- 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