New inhaled drug hopes to heal lungs in ventilator patients
NCT ID NCT07558538
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a single inhaled dose of a lab-made protein (Rh-KGF-2) in 24 adults with moderate to severe ARDS who are on ventilators. The goal is to see if the drug is safe and tolerable, and to find the right dose. Participants are split into three dose groups, with most getting the drug and a few receiving standard care alone. The study lasts 28 days and tracks side effects, oxygen levels, and lung recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant human keratinocyte growth factor-2 (Rh-KGF-2) inhaled powder
- What this could lead to
- If it works, this could point toward a new treatment to help repair lung damage in ARDS patients on ventilators.
- What could go wrong
- This is a very early, small trial (24 people) testing only a single dose. It primarily checks safety, not effectiveness, and the drug may cause airway spasms or other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged ≥18 years and \<80 years, male or female. 2. Definite diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition. 3. Patients with PaO₂/FiO₂ \< 200 mmHg and receiving invasive mechanical ventilation via endotracheal intubation. 4. Diagnosis of ARDS confirmed no more than 72 hours prior to enrollment. 5. No plan for parenthood within 1 year and agree to take effective contraceptive measures during the study period. Female participants of childbearing potential must have a negative serum pregnancy test. 6. The subject fully understands the purpose of the study, as well as the nature, methods, and potential reactions of the investigational drug. The subject voluntarily signs the informed consent form to participate in the study and agrees to comply with the requirements of the study protocol. If the subject is unable to provide consent or has limited capacity to consent, consent must be obtained from the subject's legal guardian. \- Exclusion Criteria: 1. Use of inhaled pulmonary vasodilators (e.g., nitric oxide or prostaglandins). 2. Current receipt or planned receipt of extracorporeal membrane oxygenation (ECMO) during the study period. 3. Expected survival \< 3 months due to causes other than respiratory failure. 4. Cerebrovascular or cardiovascular events within 3 months prior to study drug administration, including unstable angina, congestive heart failure, myocardial infarction within the past 12 months, hemodynamic instability, known left ventricular ejection fraction (LVEF) \< 40%, or clinically significant arrhythmia or conduction abnormality. 5. Inability to tolerate single-use bronchoscopic imaging catheter examination, including but not limited to the following: active massive hemoptysis; severe hypertension and arrhythmia; myocardial infarction or unstable angina within 4-6 weeks prior to screening; severe cardiac dysfunction; uncorrectable bleeding tendency (platelet count \< 60 × 10⁹/L), such as severe coagulation disorders, uremia, or severe pulmonary hypertension; severe superior vena cava syndrome; suspected aortic aneurysm; multiple pulmonary bullae. 6. History of severe allergic reaction, or known allergy or hypersensitivity to any component of the investigational product. 7. Breastfeeding or pregnant women. 8. Participation in any drug clinical trial within 3 months prior to enrollment. 9. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ShanghaiZhongshan
RECRUITINGShanghai, Shanghai Municipality, 200000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a different ventilator mode help ARDS patients breathe on their own faster?
- Can a smarter ventilator setting spare damaged lungs on ECMO?
- Can varying breath size protect lungs on a ventilator?
- Can matching drugs to biology beat ARDS?
- Immune cell infusion aims to free ARDS patients from ventilators
- New ventilation strategy aims to reduce lung damage in severe pneumonia