Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS

NCT07413094 | Recruiting Phase 2 DMC

• 1 other identifier: PY-YD0743-II-01
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Ventilator-Free Days

  Number of Ventilator-Free Days within 28 Days

  Within 28 days after initiation of treatment

Secondary Outcomes (6)

• 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

  At Day 3, Day 5, Day 8, Day 15 post first dose, or within 24 hours after end of treatment

• Mortality Rate

  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

  At Day 3, Day 5, Day 8, Day 15, Day 28 post first dose, or within 24 hours after end of treatment;

Study Arms (3)

Low-dose YD0743 group

EXPERIMENTAL

Each participant will receive low-dose YD0743 for 7-14 days.

Drug: YD0743

High-dose YD0743 group

EXPERIMENTAL

Each participant will receive high-dose YD0743 for 7-14 days.

Drug: YD0743

YD0743 Placebo group

PLACEBO COMPARATOR

Each participant will receive YD0743 Placebo for 7-14 days.

Drug: YD0743 Placebo

Interventions

YD0743 DRUG

Administered as a 24-hour continuous infusion via micro-infusion pump.

High-dose YD0743 group; Low-dose YD0743 group

YD0743 Placebo DRUG

Administered as a 24-hour continuous infusion via micro-infusion pump.

YD0743 Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.: lead

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Sepsis; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Bin Du, Dr.

  Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WenJing Zhang

CONTACT

021-64311017; zhang_wenjing1@hllife.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: February 17, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)