ARDS (Moderate or Severe)Early Phase 1NCT07558538
A Single Dose, Dose Escalation Clinical Trial on the Safety, Tolerability and Efficacy of Lyophilized Powder for Inhalation of Recombinant Human Keratinocyte Growth Factor-2 (Rh-KGF-2) in The Treatment of Patients With Acute Respiratory Distress Syndrome
A Early Phase 1 study testing Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder) in people with ARDS (Moderate or Severe) and ARDS (Acute Respiratory Distress Syndrome), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study is a randomized, blank-controlled, open-label, single-dose, dose-escalation clinical study of rhKGF-2 in patients with ARDS. The trial is designed with three dose groups (5 mg, 10 mg, and 15 mg), which will be escalated sequentially from the lowest dose group to the highest dose group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS (Moderate or Severe), ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2026to 30 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years and <80 years, male or female.
- Definite diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition.
- Patients with PaO₂/FiO₂ < 200 mmHg and receiving invasive mechanical ventilation via endotracheal intubation.
- Diagnosis of ARDS confirmed no more than 72 hours prior to enrollment.
- 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.
- 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.
- -
Who cannot join
- Use of inhaled pulmonary vasodilators (e.g., nitric oxide or prostaglandins).
- Current receipt or planned receipt of extracorporeal membrane oxygenation (ECMO) during the study period.
- Expected survival < 3 months due to causes other than respiratory failure.
- 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.
- 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.
- History of severe allergic reaction, or known allergy or hypersensitivity to any component of the investigational product.
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- Breastfeeding or pregnant women.
- Participation in any drug clinical trial within 3 months prior to enrollment.
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
ShanghaiZhongshan
Shanghai, Shanghai Municipality, 200000
Yi Wei, +86 18872984075, yiwei4075@163.com
About this study
This study is a randomized, blank-controlled, open-label, single-dose, dose-escalation clinical study of rhKGF-2 in patients with ARDS.
The trial is designed with three dose groups (5 mg, 10 mg, and 15 mg), which will be escalated sequentially from the lowest dose group to the highest dose group. Each dose group will enroll 8 subjects, randomized in a 6:2 ratio according to the order of enrollment, to receive either the corresponding dose of rhKGF-2 (6 subjects) or serve as a blank control (2 subjects). Each subject will receive a single dose, administered once via a disposable bronchoscopic catheter.
All subjects will receive the trial intervention on top of standard ARDS treatment (see Concomitant Medications for details). Following the completion of drug administration, subjects will enter a 28-day follow-up period. Outcome measures include adverse events (AE), vital signs, laboratory parameters, oxygenation index (PFR), chest imaging changes, etc., to evaluate the safety, tolerability, and efficacy of the treatment.
- Being tested
- Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder)
- Keywords
- ARDS (Acute Respiratory Distress Syndrome), rh-KGF2
- Medical subject headings
- Lymphoma, Follicular, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder)Drug
The investigational drug will be reconstituted with water for injection to a concentration of 1 mg/mL, and then administered via a single-use bronchoscopic imaging catheter.
| Study group | Role | What they receive |
|---|---|---|
| 5 mg rhKGF-2 | Experimental | Not described Receives: Drug: Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder) |
| Blank Control for 5 mg Cohort | No intervention | Not described |
| 10 mg rhKGF-2 | Experimental | Not described Receives: Drug: Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder) |
| Blank Control for 10 mg Cohort | No intervention | Not described |
| 15 mg rhKGF-2 | Experimental | Not described Receives: Drug: Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder) |
| Blank Control for 15 mg Cohort | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AE) and incidence of adverse drug reactions (ADR);
Measured: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
Incidence of serious adverse events (SAE)
Measured: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
Various laboratory test parameters：White blood cell (WBC) count
Unit of measure: 3.5 - 9.5 × 10^9/L
Measured: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
Various Laboratory test parameters: Serum creatinine (Cr) level
Unit of measure: 44 -115 μmol/L
Measured: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
Various laboratory test parameters: Total Bilirubin
Unit of measure: 3.4-20.4 umol /L
Measured: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
Incidence of airway spasm (increased airway resistance) caused by local drug stimulation
Measured: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
Secondary outcomes (11)
Improvement rate of oxygenation indexPaO₂/FiO₂ ratio (PFR)
Measured: at Day 3 and Day 7
PaO₂/FiO₂ ratio (PFR) and its change from baseline
Measured: at Day 3, Day 5, and Day 7
Number of days from baseline to first PaO₂/FiO₂ ratio (PFR) > 300 mmHg or liberation from mechanical ventilation for at least 12 consecutive hours
Measured: From baseline to first PFR > 300 mmHg or liberation from mechanical ventilation for at least 12 consecutive hours
Change from baseline in the Murray Lung Injury Score(LIS).
Score (scale range: 0-4; higher scores indicate more severe lung injury)
Measured: at Day 7
Change from baseline in Radiographic Assessment of Lung Edema (RALE) score;
Score (scale range: 0-48; higher scores indicate a worse outcome);
Measured: at Day 3, Day 7, Day 14, and Day 28
Proportion of patients with improvement in ARDS severity grade
Measured: at Day 7 and Day 14
Proportion of patients with progression in ARDS severity grade
Measured: at Day 7 and Day 14
All-cause mortality
Measured: at Day 28
Systemic evaluation measures: Ventilator-free days at Day 28
Ventilator-free days at Day 28 (unit: days; higher scores indicate a better outcome).
Measured: at Day 28
Systemic evaluation measures: Non-ICU hospital stay days at Day 28
Non-ICU hospital stay days at Day 28 (unit: days; higher scores indicate a better outcome as applicable).
Measured: at Day 28.
Systemic evaluation measures: Non-hospitalization days at Day 28
Non-hospitalization days at Day 28 (unit: days; higher scores indicate a better outcome).
Measured: at Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start14 May 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Moderate or Severe)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Yuanlin, Shanghai Zhongshan Hospital
- Investigators
- Yuanlin Song, Study director, Shanghai Zhongshan HospitalJing Bi, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558538
- Sponsor's protocol ID
- B2026-113R
- Status last verified
- May 2026
- First submitted
- 12 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Dose Escalation Clinical Trial on the Safety, Tolerability and Efficacy of Lyophilized Powder for Inhalation of Recombinant Human Keratinocyte Growth Factor-2 (Rh-KGF-2) in The Treatment of Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07558538
- Acronym / sponsor ID
- B2026-113R
- Keywords
- ARDS (Acute Respiratory Distress Syndrome), rh-KGF2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 14 May 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, blank-controlled, open-label, single-dose, dose-escalation clinical study of rhKGF-2 in patients with ARDS.
The trial is designed with three dose groups (5 mg, 10 mg, and 15 mg), which will be escalated sequentially from the lowest dose group to the highest dose group. Each dose group will enroll 8 subjects, randomized in a 6:2 ratio according to the order of enrollment, to receive either the corresponding dose of rhKGF-2 (6 subjects) or serve as a blank control (2 subjects). Each subject will receive a single dose, administered once via a disposable bronchoscopic catheter.
All subjects will receive the trial intervention on top of standard ARDS treatment (see Concomitant Medications for details). Following the completion of drug administration, subjects will enter a 28-day follow-up period. Outcome measures include adverse events (AE), vital signs, laboratory parameters, oxygenation index (PFR), chest imaging changes, etc., to evaluate the safety, tolerability, and efficacy of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 5 mg rhKGF-2 | Experimental | Drug: Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder) |
| Blank Control for 5 mg Cohort | No intervention | – |
| 10 mg rhKGF-2 | Experimental | Drug: Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder) |
| Blank Control for 10 mg Cohort | No intervention | – |
| 15 mg rhKGF-2 | Experimental | Drug: Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder) |
| Blank Control for 15 mg Cohort | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18 years and <80 years, male or female.
- Definite diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition.
- Patients with PaO₂/FiO₂ < 200 mmHg and receiving invasive mechanical ventilation via endotracheal intubation.
- Diagnosis of ARDS confirmed no more than 72 hours prior to enrollment.
- 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.
Key exclusion criteria (9 listed)
- Use of inhaled pulmonary vasodilators (e.g., nitric oxide or prostaglandins).
- Current receipt or planned receipt of extracorporeal membrane oxygenation (ECMO) during the study period.
- Expected survival < 3 months due to causes other than respiratory failure.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder)The investigational drug will be reconstituted with water for injection to a concentration of 1 mg/mL, and then administered via a single-use bronchoscopic imaging catheter. | Drug | 10 mg rhKGF-2, 15 mg rhKGF-2, 5 mg rhKGF-2 |
Primary outcome
Incidence of adverse events (AE) and incidence of adverse drug reactions (ADR);
Time frame: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
Incidence of serious adverse events (SAE)
Time frame: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
Various laboratory test parameters：White blood cell (WBC) count
Time frame: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
Unit of measure: 3.5 - 9.5 × 10^9/L
Various Laboratory test parameters: Serum creatinine (Cr) level
Time frame: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
Unit of measure: 44 -115 μmol/L
Various laboratory test parameters: Total Bilirubin
Time frame: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
Unit of measure: 3.4-20.4 umol /L
Incidence of airway spasm (increased airway resistance) caused by local drug stimulation
Time frame: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.
11 secondary outcomes
Improvement rate of oxygenation indexPaO₂/FiO₂ ratio (PFR)
Time frame: at Day 3 and Day 7
PaO₂/FiO₂ ratio (PFR) and its change from baseline
Time frame: at Day 3, Day 5, and Day 7
Number of days from baseline to first PaO₂/FiO₂ ratio (PFR) > 300 mmHg or liberation from mechanical ventilation for at least 12 consecutive hours
Time frame: From baseline to first PFR > 300 mmHg or liberation from mechanical ventilation for at least 12 consecutive hours
Change from baseline in the Murray Lung Injury Score(LIS).
Time frame: at Day 7
Change from baseline in Radiographic Assessment of Lung Edema (RALE) score;
Time frame: at Day 3, Day 7, Day 14, and Day 28
Proportion of patients with improvement in ARDS severity grade
Time frame: at Day 7 and Day 14
Proportion of patients with progression in ARDS severity grade
Time frame: at Day 7 and Day 14
All-cause mortality
Time frame: at Day 28
Systemic evaluation measures: Ventilator-free days at Day 28
Time frame: at Day 28
Systemic evaluation measures: Non-ICU hospital stay days at Day 28
Time frame: at Day 28.
Systemic evaluation measures: Non-hospitalization days at Day 28
Time frame: at Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuanlin Song study director
Shanghai Zhongshan Hospital
Jing Bi principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder) in people with ARDS (Moderate or Severe) and ARDS (Acute Respiratory Distress Syndrome), run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Wei (+86 18872984075, yiwei4075@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AE) and incidence of adverse drug reactions (ADR); (time frame: At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.