SepsisPhase 2NCT07413094
Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS
A Phase 2 study testing YD0743 in people with Sepsis, run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis
- What is being tested?
- YD0743
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 309 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, 100730
Bin Du, Doctor, 13601366216, dubin98@gmail.com
About this study
Official title: 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?
Read more
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
- Being tested
- YD0743, YD0743 Placebo
- Keywords
- Acute respiratory distress syndrome
- Medical subject headings
- Sepsis, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YD0743Drug
Administered as a 24-hour continuous infusion via micro-infusion pump.
YD0743 PlaceboDrug
Administered as a 24-hour continuous infusion via micro-infusion pump.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose YD0743 group | Experimental | Each participant will receive low-dose YD0743 for 7-14 days. Receives: Drug: YD0743 |
| High-dose YD0743 group | Experimental | Each participant will receive high-dose YD0743 for 7-14 days. Receives: Drug: YD0743 |
| YD0743 Placebo group | Placebo comparator | Each participant will receive YD0743 Placebo for 7-14 days. Receives: Drug: YD0743 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Ventilator-Free Days
Number of Ventilator-Free Days within 28 Days
Measured: Within 28 days after initiation of treatment
Secondary outcomes (6)
Change from Baseline and Change Rate in Oxygenation Index (PaO₂/FiO₂ Ratio)
Measured: 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)
Measured: 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
Measured: Within 28 days after initiation of treatment
Number of ICU Days and Total Hospital Days
Measured: 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.
Measured: 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.
Measured: Within 28 days after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start2 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin Du, Dr., Principal investigator, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413094
- Sponsor's protocol ID
- PY-YD0743-II-01
- Status last verified
- Feb 2026
- First submitted
- 4 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07413094
- Acronym / sponsor ID
- PY-YD0743-II-01
- Conditions
- Sepsis
- Keywords
- Acute respiratory distress syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose YD0743 group | Experimental | Drug: YD0743Each participant will receive low-dose YD0743 for 7-14 days. |
| High-dose YD0743 group | Experimental | Drug: YD0743Each participant will receive high-dose YD0743 for 7-14 days. |
| YD0743 Placebo group | Placebo comparator | Drug: YD0743 PlaceboEach participant will receive YD0743 Placebo for 7-14 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YD0743Administered as a 24-hour continuous infusion via micro-infusion pump. | Drug | High-dose YD0743 group, Low-dose YD0743 group |
| YD0743 PlaceboAdministered as a 24-hour continuous infusion via micro-infusion pump. | Drug | YD0743 Placebo group |
Primary outcome
Number of Ventilator-Free Days
Time frame: Within 28 days after initiation of treatment
Number of Ventilator-Free Days within 28 Days
6 secondary outcomes
Change from Baseline and Change Rate in Oxygenation Index (PaO₂/FiO₂ Ratio)
Time frame: 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
Time frame: At Day 3, Day 5, Day 8, Day 15 post first dose, or within 24 hours after end of treatment
Mortality Rate
Time frame: Within 28 days after initiation of treatment
Number of ICU Days and Total Hospital Days
Time frame: Within 28 days after initiation of treatment
Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score
Time frame: 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)
Time frame: Within 28 days after initiation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bin Du, Dr. principal investigator
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YD0743 in people with Sepsis, run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WenJing Zhang (021-64311017, zhang_wenjing1@hllife.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Ventilator-Free Days (time frame: Within 28 days after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.