Clinical Trial 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

NCT07558538 | Not Yet Recruiting Early Phase 1

• 1 other identifier: B2026-113R
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ARDS (Moderate or Severe); ARDS (Acute Respiratory Distress Syndrome)

Keywords

ARDS (Acute Respiratory Distress Syndrome); rh-KGF2

Outcome Measures

Primary Outcomes (6)

• Incidence of adverse events (AE) and incidence of adverse drug reactions (ADR);

  At Baseline, Day 1, Day 2, Day 3, Day 5, Day 7, Day 14 and Day 28.

• Incidence of serious adverse events (SAE)

  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

  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

  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

  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

  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)

  at Day 3 and Day 7

• PaO₂/FiO₂ ratio (PFR) and its change from baseline

  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

  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).

  at Day 7

• Change from baseline in Radiographic Assessment of Lung Edema (RALE) score;

  at Day 3, Day 7, Day 14, and Day 28

Study Arms (6)

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

Interventions

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.

10 mg rhKGF-2; 15 mg rhKGF-2; 5 mg rhKGF-2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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, 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.
• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

ShanghaiZhongshan

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Acute Lung Injury

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Yuanlin Song

  Shanghai Zhongshan Hospital

  STUDY DIRECTOR

• Jing Bi

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Wei

CONTACT

+86 18872984075; yiwei4075@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 30, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Sharing will begin within 6 months after article publication.
• Access Criteria: IPD and supporting information will be avaible to researchers upon reasonable request (e.g. with a practical and meaningful research proposal).

Locations

CN (1)