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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

NCT07558538 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-11

No results posted yet for this study

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)

Interventions

DRUG

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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Yuanlin Song · Shanghai Zhongshan Hospital

  • Jing Bi · Shanghai Zhongshan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-14
Primary Completion
2026-11-30
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07558538 on ClinicalTrials.gov