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Protein Replacement Therapy

AT-100 for Bronchopulmonary Dysplasia

Phase 1
Waitlist Available
Led By Brenda L Poindexter, MD, MS
Research Sponsored by Airway Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Preterm neonates born between Gestational Age (GA): 23 0/7 weeks to 28 6/7 weeks in the latter cohort
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 36 pma
Awards & highlights

Study Summary

This trial will test if a new drug can reduce the occurrence of a lung disease in premature babies.

Who is the study for?
This trial is for preterm neonates born between 23 and 28 weeks of gestation, intubated and on mechanical ventilation. They must have received a standard surfactant treatment and can get the first dose of AT-100 or air-sham within 96 hours of birth. Neonates with major congenital issues, active infections like COVID-19 or CMV, drug abuse in mothers (except marijuana), or those very likely to be extubated soon after surfactant treatment are excluded.Check my eligibility
What is being tested?
The study tests if AT-100 can prevent Bronchopulmonary Dysplasia in premature babies compared to an air-sham procedure. Babies will receive either the investigational drug AT-100 or a sham air treatment shortly after birth while they're on mechanical ventilation.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to immune response due to the nature of AT-100 as a therapeutic protein, respiratory complications given the condition being treated, and general risks associated with interventions in preterm neonates.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My baby was born prematurely, between 23 and 29 weeks of pregnancy.
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My newborn received a surfactant dose and can get the first AT-100 or air-sham dose within 96 hours of birth.
Select...
My baby was born between 25 and 29 weeks of pregnancy.
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I am currently on a breathing machine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36 pma
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 pma for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of BPD or death
Number of participants with treatment-related adverse events
Secondary outcome measures
BPD or death
Time on mechanical ventilation

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 1b open-label AT-100Experimental Treatment1 Intervention
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).
Group II: Phase 1b open-label air-shamPlacebo Group1 Intervention
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).

Find a Location

Who is running the clinical trial?

Airway Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
Paul S. Kingma, MD, PhDStudy DirectorAirway Therapeutics, Inc.
Brenda L Poindexter, MD, MSPrincipal InvestigatorEmory University

Media Library

AT-100 (Protein Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04662151 — Phase 1
Bronchopulmonary Dysplasia Research Study Groups: Phase 1b open-label AT-100, Phase 1b open-label air-sham
Bronchopulmonary Dysplasia Clinical Trial 2023: AT-100 Highlights & Side Effects. Trial Name: NCT04662151 — Phase 1
AT-100 (Protein Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04662151 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor open to participants of 45 years or older?

"According to the entry requirements, only those between 0 Minutes and 96 Hours old are eligible. Additionally, there exists 71 clinical trials for minors and 108 studies tailored towards elderly patients."

Answered by AI

How many locations have been designated for the performance of this trial?

"Currently, 12 sites are distributing the medication and participating in this trial. While Nashville, Boston, and Los Angeles are three of these locations, there are also 9 additional ones available. To minimize travel burdens while taking part in this study it is encouraged to select a centre close by."

Answered by AI

Has AT-100 obtained clearance from the FDA?

"AT-100's safety rating is 1, as it has only been through the initial stages of clinical trials and therefore lacks substantial data to back its efficacy or security."

Answered by AI

Is this research team actively seeking participants?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, started on September 1st 2021, is still actively recruiting participants. The 36 required patients should be sourced from 12 separate medical centres."

Answered by AI

What constitutes the criteria to become an eligible participant in this clinical trial?

"Qualified participants must be afflicted with Bronchopulmonary Dysplasia and range between 0 Minutes to 96 Hours of age. This trial is attempting to enroll a total of 36 patients."

Answered by AI

How many patients have been accepted into this research experiment?

"Affirmative. According to clinicaltrials.gov, recruitment for this medical study is ongoing; it was first posted on September 1st 2021 and last edited on October 20th 2022 with the goal of enrolling 36 volunteers across 12 different sites."

Answered by AI
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~10 spots leftby Mar 2025