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To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

Recruiting
18 - 85 years of age
Both
Phase 1/2

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Overview

To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.

Eligibility

Inclusion Criteria:

  • 18 years old≤Age≤85 years old;
  • In 14 days since the onset of respiratory infective symptoms (in 12 days for non-invasive mechanical ventilation patients);
  • The nearest PaO2/FiO2≤200mmHg;
  • Low peripheral blood lymphocyte count;
  • Patients (including patients' partners) did not plan to have children during the trial period and for 4 months after the end of the last dose and agreed to use appropriate and effective contraceptive methods;

Exclusion Criteria:

  • Use ECMO before first administration;
  • The time between first administration and invasive mechanical ventilation was more than 48h;
  • Survival is expected to be no more than 24 hours or a cardiac arrest has occurred 4 weeks before screening;
  • Vital organs failure, including the liver, kidneys and heart;
  • Immunosuppressed state;
  • Serious underlying disease.

Study details

Acute Respiratory Distress Syndrome

NCT06038916

Staidson (Beijing) Biopharmaceuticals Co., Ltd

26 January 2024

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