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.
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.
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.
Parallel
Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder)
DrugThe 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.
6
Treatment groupsSee each treatment group below.
Incidence of adverse events (AE) and incidence of adverse drug reactions (ADR);
Incidence of serious adverse events (SAE)
Various laboratory test parameters：White blood cell (WBC) count
Unit of measure: 3.5 - 9.5 × 10\^9/L
Various Laboratory test parameters: Serum creatinine (Cr) level
Unit of measure: 44 -115 μmol/L
Improvement rate of oxygenation indexPaO₂/FiO₂ ratio (PFR)
PaO₂/FiO₂ ratio (PFR) and its change from baseline
Number of days from baseline to first PaO₂/FiO₂ ratio (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)
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