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New inhaled drug hopes to heal lungs in ventilator patients

NCT ID NCT07558538

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • ShanghaiZhongshan

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.