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

NCT04662151 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-07-03

No results posted yet for this study

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.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

BIOLOGICAL

AT-100

reconstituted AT-100 for intratracheal administration

PROCEDURE

Air-sham

room air for intratracheal administration

Sponsors & Collaborators

  • Airway Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Marc O. Salzberg, MD · Airway Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Minutes
Max Age
96 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-08-14
Completion
2024-05-29
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04662151 on ClinicalTrials.gov