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

Last updated: July 10, 2025
Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Overall Status: Completed

Phase

1/2

Condition

Lung Injury

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Treatment

STSA-1002 Injection Placebo

STSA-1002 Injection

Clinical Study ID

NCT06038916
STSA-1002-04
  • Ages 18-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years old≤Age≤85 years old;

  2. Pathogen results indicate respiratory viral infection;

  3. Acute respiratory distress syndrome (ARDS) caused by viral pneumonia;

  4. In 14haode days since the onset of respiratory infective symptoms (in 12 days fornon-invasive mechanical ventilation patients);

  5. PaO₂/FiO₂ ≤200 mmHg based on arterial blood gas analysis prior to randomization;

  6. Most recent peripheral blood lymphocyte count ≤0.8×10^9/L prior to randomization;

  7. Patients (including patients' partners) has no plans for conception during the studyperiod and within 4 months following the last dose, and agrees to use appropriateand effective contraception (e.g., birth control pills, condoms);

  8. Willing to participate in the study and signs the informed consent form

Exclusion

Exclusion Criteria:

  1. Use of ECMO before the first administration;

  2. More than 48 hours of invasive mechanical ventilation prior to the first dose;

  3. Based on the researchers' overall assessment, the patient's condition improvedwithin the first 48 hours prior to the initial dosing (predictable improvement inoxygenation indicators observed within the next 48 hours);

  4. Expected survival period of less than 24 hours or a history of cardiac arrest within 4 weeks prior to screening;

  5. Recent history of stroke or acute coronary syndrome;

  6. Diagnosed with fungal pneumonia (Aspergillus, Mucor, Cryptococcus, or Pneumocystisjirovecii pneumonia);

  7. Suspected or known cytomegalovirus infection;

  8. Suspected or known active tuberculosis;

  9. Experienced prolonged fluid resuscitation-resistant septic shock.

  10. Severe chronic respiratory failure;

  11. Deemed by the investigator as difficult to wean from ventilation due to severeunderlying diseases;

  12. Cardiogenic pulmonary edema or congestive heart failure;

  13. Liver dysfunction;

  14. Severe renal impairment or long-term dialysis;

  15. Immunocompromised state;

  16. A Absolute neutrophil count is excessively low;

  17. Severe anemia or active bleeding;

  18. Poor compliance with standard treatment;

  19. Pregnant or breastfeeding women;

  20. Participated in a clinical trial of a new drug and received treatment within 3months prior to screening;

  21. Any condition that the investigator believes may increase the risk to the patient orinterfere with the execution of the clinical trial;

  22. Known allergy to any component of the investigational drug or its excipients, or ahistory of hypersensitivity (e.g., allergic to two or more drugs);

  23. Any other disease or condition that, in the investigator's opinion, makes thepatient unsuitable for participation in this study;

Study Design

Total Participants: 47
Treatment Group(s): 2
Primary Treatment: STSA-1002 Injection Placebo
Phase: 1/2
Study Start date:
December 09, 2023
Estimated Completion Date:
April 27, 2025

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233099
    China

    Active - Recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui 233099
    China

    Site Not Available

  • Beijing Luhe Hospital affiliated to Capital Medical University

    Beijing, Beijing 101199
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing, Beijing 100029
    China

    Site Not Available

  • The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University

    Chongqing, Chongqing 400038
    China

    Site Not Available

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong 518036
    China

    Site Not Available

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi 530016
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University City:Shijiazhuang

    Shijiazhuang, Hebei 050011
    China

    Site Not Available

  • Huaihe Hospital of Henan University

    Kaifeng, Henan 450001
    China

    Site Not Available

  • Kaifeng Central Hospital

    Kaifeng, Henan 475000
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 471099
    China

    Site Not Available

  • The First Affiliated Hospital of Xinxiang Medical College

    Xingxiang, Henan 453100
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Wuhan Jinyintan Hospital

    Wuhan, Hubei 430048
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430062
    China

    Site Not Available

  • Xiangtan Central Hospital

    Xiangtan, Hunan 411100
    China

    Site Not Available

  • Zhongda Hospital affiliated to Southeast University

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • Qingdao Municipal Hospital

    Qingdao, Shandong 266071
    China

    Site Not Available

  • Zibo Municipal Hospital

    Zibo, Shandong 255000
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200001
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030032
    China

    Site Not Available

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan 611130
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Site Not Available

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan 610599
    China

    Site Not Available

  • Hangzhou Red Cross Hospital

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325035
    China

    Site Not Available

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