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Study to Test if Zelpultide Alfa Helps Prevent Lung Disease in High-Risk Premature Babies

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as bronchopulmonary dysplasia (BPD), which affects the lungs of very premature babies. The trial is investigating a treatment called zelpultide alfa, also known by its code name AT-100. This treatment is a type of protein that is similar to a natural substance found in the lungs, called recombinant human surfactant protein-D. The study aims to find out if adding zelpultide alfa to the usual care can help protect the lungs and prevent lung injury in these high-risk infants.

The purpose of the study is to compare the effectiveness of zelpultide alfa combined with the standard care against the standard care plus a placebo, which is a treatment that looks like the real one but has no active ingredients. The trial will involve very premature babies who are at high risk of developing BPD. These babies will receive either the new treatment or the placebo, in addition to the usual care they would normally receive. The study will monitor the babies to see if the new treatment helps reduce the occurrence of severe BPD or death by the time they reach 36 weeks of age, which is a common milestone for assessing lung health in premature infants.

Throughout the study, researchers will also look at other factors, such as the number of days the babies can breathe without the help of a ventilator and the overall survival rate by the 36-week mark. The trial is designed to provide valuable information on whether zelpultide alfa can offer additional protection for the lungs of these vulnerable infants, potentially leading to better outcomes and fewer complications related to BPD.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The study involves very premature babies born between 23 weeks and 27 weeks and 6 days of gestation.

    The baby must have received at least one dose of the usual treatment for lung support after birth.

    The baby must be on a breathing machine as part of the usual care.

  2. Step 2

    Initial treatment

    The baby will receive the first dose of zelpultide alfa or a placebo (a harmless substance) at least 15 minutes after the usual lung treatment but within 96 hours of birth and within 48 hours from starting the breathing machine.

    If the baby was taken off the breathing machine and then put back on, they can still receive the treatment if they meet the criteria.

  3. Step 3

    Treatment administration

    Zelpultide alfa is given through a method called endotracheopulmonary instillation, which means it is delivered directly into the lungs.

    The treatment is a solution that is administered in room air.

  4. Step 4

    Monitoring and follow-up

    The baby's health will be monitored to see if they develop a lung condition called bronchopulmonary dysplasia (BPD) or if there are any other health concerns.

    The main goal is to see if zelpultide alfa helps prevent BPD or reduces the risk of death by the time the baby reaches 36 weeks of corrected age.

  5. Step 5

    Study duration

    The study is expected to continue until March 2027.

    The recruitment of participants is estimated to start in October 2024.

Who can join the trial?

5 criteria

  • The baby must be born between **23 weeks and 27 weeks and 6 days** of pregnancy.
  • The baby must have received at least one dose of a special treatment called **pulmonary surfactant**, which helps the lungs work better, after birth.
  • The baby must be using a breathing machine, known as **invasive mechanical ventilation**, as part of their standard care.
  • The baby must be able to receive the first dose of the study medication, **zelpultide alfa**, or a pretend treatment, called **air-sham**, at least 15 minutes after the surfactant treatment but within 96 hours of birth and within 48 hours from starting the breathing machine. If the baby was taken off the breathing machine and then put back on after receiving the surfactant, they can still participate if they meet all the criteria.
  • The baby's parent(s) or legal guardian(s) must sign a form giving their permission for the baby to participate in the study and allowing the use of personal information.

Who cannot join the trial?

4 criteria

  • Neonates who are not born prematurely cannot participate.
  • Neonates who are not at high risk for developing bronchopulmonary dysplasia (BPD) cannot participate. BPD is a lung condition that can affect newborns, especially those born early.
  • Neonates who are not within the specified age range for the study cannot participate.
  • Neonates who do not meet the study's health and safety requirements cannot participate.
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Investigated drugs

Zelpultide Alfa is a medication being studied to see if it can help prevent a lung condition called bronchopulmonary dysplasia (BPD) in premature babies who are at high risk. The trial is testing whether adding Zelpultide Alfa to the usual care that these babies receive can reduce the chances of developing severe forms of BPD or dying from the condition.

What is already known about the treatment

Zelpultide Alfa – Zelpultide Alfa is administered intravenously, typically in a hospital setting, to preterm neonates at high risk for developing bronchopulmonary dysplasia (BPD). It is currently being studied in a Phase 3 clinical trial to assess its effectiveness in preventing BPD compared to standard care. The main therapeutic indication for Zelpultide Alfa is to reduce the incidence of severe BPD and related mortality in premature infants. At the molecular level, it works by modulating inflammatory pathways that contribute to lung damage in preterm infants. Zelpultide Alfa is classified as a biologic agent, specifically designed to target and mitigate inflammatory responses in the lungs.

Investigated diseases

  • Prematurity in Neonates

    This condition occurs when a baby is born before the 37th week of pregnancy. Premature infants often have underdeveloped organs, which can lead to various health challenges. They may experience difficulties with breathing, feeding, and maintaining body temperature. The risk of infections and other complications is higher in these infants due to their immature immune systems. As they grow, they may face developmental delays and require specialized medical care. The progression of health issues in premature neonates can vary widely depending on the degree of prematurity and individual health factors.

  • Bronchopulmonary Dysplasia

    This is a chronic lung condition that affects newborns, primarily those who are born prematurely and require oxygen therapy. It is characterized by inflammation and scarring in the lungs. The condition develops as a result of damage to the lungs caused by mechanical ventilation and long-term use of oxygen. Infants with bronchopulmonary dysplasia may experience difficulty breathing and require prolonged respiratory support. Over time, the condition can lead to long-term respiratory problems and may affect growth and development. The severity of the disease can range from mild to severe, impacting the infant's overall health and quality of life.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IVTrial ID2024-513420-41-00Protocol codeZEL-003Estimated enrolment276 patientsSponsorAirway Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).