NCT07208591

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

Phase Ⅲ Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Acute Respiratory Distress Syndrome (ARDS)

Interventions

Type	Name	Description
DRUG	STSA-1002 injection	basal treatment + STASA-1002 intravenous infusion
DRUG	STSA-1002 Injection Placebo	basal treatment + STSA-1002 Injection Placebo

Timeline

• Start date: 2025-10-31
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2025-10-06
• Last updated: 2026-01-02

Locations

15 sites across 1 country: China