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

• Status: Recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

Criteria

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.