NCT04662151|CompletedPhase 1DMCFDA Drug

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

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)

Airway Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

AT-100/001

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredDec 2020

StartedSep 2021

CompletionMay 2024

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Sep 2021

Typical duration for phase_1

Geographic Reach

2 countries

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

December 4, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed

9 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2023

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2024

Completed

Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

December 4, 2020

Last Update Submit

July 2, 2024

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary DysplasiaPretermNeonateMechanical ventilationRespiratory supportrecombinant human Surfactant Protein-D (rhSP-D)intratrachealair-sham

Outcome Measures

Primary Outcomes (2)

Number of participants with treatment-related adverse events
Incidence and severity of adverse events between the two treatment groups will be compared
Adverse events will be followed up to Day 28 of life
Incidence of BPD or death
Week 36 PMA

Study Arms (2)

Phase 1b open-label AT-100

EXPERIMENTAL

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).

Biological: AT-100

Phase 1b open-label air-sham

SHAM COMPARATOR

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).

Procedure: Air-sham

Interventions

AT-100BIOLOGICAL

reconstituted AT-100 for intratracheal administration

Also known as: (rhSP-D)

Phase 1b open-label AT-100

Air-shamPROCEDURE

room air for intratracheal administration

Phase 1b open-label air-sham

Eligibility Criteria

Age0 Minutes - 96 Hours

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Preterm neonates born between Gestional Age (GA):
/7 weeks to 28 6/7 weeks in the initial dose escalation cohorts.
/7 weeks to 28 6/7 weeks in the latter cohort.
Intubated and on mechanical ventilation.
Receiving at least 1 dose of standard-of-care-indicated surfactant treatment (Curosurf®) after birth, and able to receive the first dose of AT-100 or air-sham within 96 hours of birth given at any time point after 15 minutes following any of the subject's Curosurf® dose(s).
Parent or legal guardian is able to provide informed consent.

You may not qualify if:

Weight at time of birth \< 400 g or \> 1,800 g.
Major apparent congenital abnormalities impacting cardio and pulmonary function.
Active DNR (Do Not Resuscitate) order in place.
Known pulmonary air leaks (e.g. pneumothorax and pneumomediastinum) at the time of AT-100 or air-sham administration.
History of allergy or sensitivity to any surfactant or any component of the Investigational Product (AT-100).
AT-100 or air-sham dosing was set to occur before Data Safety Monitoring Committee recommendation to proceed to the next dose-escalation cohort.
Use of minimally invasive surfactant techniques (e.g., LISA, MIST) or INSURE or if, in the opinion of the care team, the infant is very likely too be extubated shortly after receiving Curosurf®.
Birth mother:
Has known active Hepatitis B, C, or E diagnosis.
Has a 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.
Has known active Sexually Transmitted Infection (STI).
Has known Cytomegalovirus (CMV) active infection.
Has known history or evidence of alcohol or drug abuse, wit the exception of marijuana/marijuana-based products/THC, based on a positive maternal or infant drug screen as evidenced by the institution's standard-of-care practice.
Concurrent enrollment in an investigational drug, device, or treatment modulation trial that utilizes treatments outside of standard-of-care.
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.
+1 more criteria

Contact the study team to confirm eligibility.