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

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) .

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Drug: YD0743; Drug: YD0743 Placebo

• Study Type: Interventional
• Enrollment (Estimated): 309
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: WenJing Zhang; Phone Number: 021-64311017; Email: zhang_wenjing1@hllife.com.cn

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
    • Contact: Bin Du, Doctor; Phone Number: 13601366216; Email: dubin98@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, aged between 18 and 75 years (inclusive).
• Diagnosis of sepsis.
• Diagnosis of Acute Respiratory Distress Syndrome (ARDS) suspected or confirmed to be caused by sepsis.
• Time from ARDS diagnosis to signing the informed consent form (ICF) does not exceed 48 hours.
• The subject (or their legally authorized representative) has fully understood the study's purpose, nature, procedures, and potential adverse events, voluntarily agrees to participate, and provides written informed consent.

Exclusion Criteria:

• Known allergy or hypersensitivity to the active ingredient or any excipients of the investigational product; or a history of allergic disorders.
• Expected survival time is less than 48 hours at the time of screening.
• Sepsis with extensive burns as the primary cause.
• Currently diagnosed with active malignancy; or malignancy with distant metastasis; or cancer patients with cachexia; or patients with severe organ dysfunction or visceral hemorrhage due to tumor obstruction, space-occupying effect, or compression, for whom surgical intervention is difficult or has not yet been performed.
• Currently receiving or requiring Extracorporeal Membrane Oxygenation (ECMO) therapy.
• Presence of chronic severe organ failure or immunodeficiency/immunosuppression.
• Thrombocytopenia at screening, active/uncontrolled bleeding, or patients whom the investigator considers to have a current or prior high risk of bleeding.
• Diagnosis of neutropenia.
• Positive for Hepatitis B surface antigen (HBsAg) with HBV-DNA > 1000 copies/mL or 200 IU/mL; positive for Hepatitis C virus antibody (HCV-Ab); positive for Human Immunodeficiency Virus antibody (HIV-Ab); or positive for Treponema pallidum antibody.
• Participation in other drug or medical device clinical trials within 3 months prior to this study, or current participation in another clinical trial.
• Pregnant or breastfeeding women, or women planning to become pregnant within the next 6 months.
• Patients whose underlying primary disease cannot be effectively treated.
• Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dose YD0743 group; Each participant will receive low-dose YD0743 for 7-14 days.	Drug: YD0743; Administered as a 24-hour continuous infusion via micro-infusion pump.
Experimental: High-dose YD0743 group; Each participant will receive high-dose YD0743 for 7-14 days.	Drug: YD0743; Administered as a 24-hour continuous infusion via micro-infusion pump.
Placebo Comparator: YD0743 Placebo group; Each participant will receive YD0743 Placebo for 7-14 days.	Drug: YD0743 Placebo; Administered as a 24-hour continuous infusion via micro-infusion pump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Ventilator-Free Days	Number of Ventilator-Free Days within 28 Days	Within 28 days after initiation of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline and Change Rate in Oxygenation Index (PaO₂/FiO₂ Ratio)		At Day 3, Day 5, Day 8, Day 15 post first dose, or within 24 hours after the end of treatment
Change from Baseline in Driving Pressure and Static Lung Compliance in participants receiving invasive mechanical ventilation	Formulas for Driving Pressure and Static Lung Compliance: Driving Pressure (ΔP) = Plateau Pressure(Pplat) - Positive End-Expiratory Pressure (PEEP) Static Lung Compliance = Tidal Volume/(Pplat - PEEP)	At Day 3, Day 5, Day 8, Day 15 post first dose, or within 24 hours after end of treatment
Mortality Rate	ICU Mortality Rate, In-Hospital Mortality Rate, 28-Day All-Cause Mortality Rate, and Survival Time of participants who died within 28 days	Within 28 days after initiation of treatment
Number of ICU Days and Total Hospital Days		Within 28 days after initiation of treatment
Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score	The SOFA score is a scale ranging from 0 to 24 points, with higher scores indicating worse organ function/a worse outcome.	At Day 3, Day 5, Day 8, Day 15, Day 28 post first dose, or within 24 hours after end of treatment;
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	Within 28 days after initiation of treatment

Collaborators and Investigators

• Sponsor: Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
• Investigators: Principal Investigator: Bin Du, Dr., Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Acute respiratory distress syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Lung Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Distress Syndrome; Sepsis
• Other Study ID Numbers: PY-YD0743-II-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No