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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
Preterm neonates born between Gestational Age (GA): 25 0/7 weeks to 28 6/7 weeks in the initial dose escalation cohorts
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 belowSelect...
My baby was born prematurely, between 23 and 29 weeks of pregnancy.
Select...
My baby was born between 25 and 29 weeks of pregnancy.
Select...
I am currently on a breathing machine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 36 pma
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36 pma
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).
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was born prematurely, between 23 and 29 weeks of pregnancy.I have major birth defects affecting my heart and lungs.You have a current order that says not to resuscitate (bring back to life).The birth mother has a serious illness or has been exposed to something that may weaken the immune system, such as HIV or chemotherapy.My newborn received a surfactant dose and can get the first AT-100 or air-sham dose within 96 hours of birth.My birth mother has an active Hepatitis B, C, or E infection.I currently have air leaks in my lungs.I was re-intubated after my Curosurf® dose but meet other required conditions.My birth mother has a history of drug or alcohol abuse, excluding marijuana.My baby might receive a special lung treatment soon or just had one.I had COVID-19 symptoms and a positive test around my child's birth.My birth mother has an active CMV infection.I am not allergic to any ingredients in the trial medication.My baby was born between 25 and 29 weeks of pregnancy.My birth weight was either below 400g or above 1,800g.You received AT-100 or a fake treatment before it was approved to move to the next level of dosage.I am currently on a breathing machine.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b open-label AT-100
- Group 2: Phase 1b open-label air-sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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