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Tests treatment safety and results for ARDS (Moderate or Severe)
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
What this study is testing
What is Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder)?
Recombinant Human Keratinocyte Growth Factor-2 for Inhalation (Lyophilized Powder) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for ards (moderate or severe).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
You likely can't join if
- 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...
- Inability to tolerate single-use bronchoscopic imaging catheter examination, including but not limited to the following: active massive hemoptysis...
- History of severe allergic reaction, or known allergy or hypersensitivity to any component of the investigational product.
See the full eligibility criteria
- 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...
- 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...
- 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...
- History of severe allergic reaction, or known allergy or hypersensitivity to any component of the investigational product.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.