NCT07413094

Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS

A Multicenter, Parallel, Randomized, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of YD0743 Injection in the Treatment of Sepsis-Associated Acute Respiratory Distress Syndrome

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 309 (estimated)
• Sponsor: Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if YD0743 works to treat sepsis-associated acute respiratory distress syndrome (ARDS) in adult patients admitted to the Intensive Care Unit. It will also learn about the safety of drug YD0743. The main questions it aims to answer are: Does YD0743 injection shorten the ventilator-using days in sepsis-associated ARDS patients? What medical problems do participants have when accepting YD0743 treatment? Researchers will compare YD0743 to a placebo (a look-alike substance that contains no active drug) to see if YD0743 works to treat sepsis-associated ARDS. Participants will: Accepting YD0743 injection at least for 7 days. Visit the clinic in person at the Day 28 to receive the follow-up check (D1 is defined as the first day starting the YD0743 or placebo treatment) .

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	YD0743	Administered as a 24-hour continuous infusion via micro-infusion pump.
DRUG	YD0743 Placebo	Administered as a 24-hour continuous infusion via micro-infusion pump.

Timeline

• Start date: 2026-02-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: China