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

Phase Ib/II Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

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

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Drug: STSA-1002 Injection Placebo; Drug: STSA-1002 Injection

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233099
      • The First Affiliated Hospital of Bengbu Medical University
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China, 101199
      • Beijing Luhe Hospital Affiliated to Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
  • Guangdong
    • Shenzhen, Guangdong, China, 518036
      • Peking University Shenzhen Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530016
      • The People's Hospital Of Guangxi Zhuang Autonomous Region
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • The Second Hospital of Hebei Medical University City:Shijiazhuang
  • Henan
    • Kaifeng, Henan, China, 475000
      • Kaifeng Central Hospital
    • Kaifeng, Henan, China, 450001
      • Huaihe Hospital of Henan University
    • Luoyang, Henan, China, 471099
      • The First Affiliated Hospital of Henan University of Science and Technology
    • Xingxiang, Henan, China, 453100
      • The First Affiliated Hospital of Xinxiang Medical College
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430062
      • Zhongnan Hospital of Wuhan University
    • Wuhan, Hubei, China, 430048
      • Wuhan Jinyintan Hospital
  • Hunan
    • Xiangtan, Hunan, China, 411100
      • Xiangtan Central Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Affiliated to Southeast University
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital Of Nanchang University
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
    • Qingdao, Shandong, China, 266071
      • Qingdao Municipal Hospital
    • Zibo, Shandong, China, 255000
      • Zibo Municipal Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200001
      • Renji Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Shanxi Bethune Hospital
    • Xi'an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi 'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 611130
      • Chengdu Fifth People's Hospital
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital
    • Chengdu, Sichuan, China, 610599
      • The First Affiliated Hospital of Chengdu Medical College
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Hangzhou Red Cross Hospital
    • Wenzhou, Zhejiang, China, 325035
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

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

Description

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 for non-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 study period and within 4 months following the last dose, and agrees to use appropriate and effective contraception (e.g., birth control pills, condoms);
8. Willing to participate in the study and signs the informed consent form

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 improved within the first 48 hours prior to the initial dosing (predictable improvement in oxygenation 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 Pneumocystis jirovecii 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 severe underlying 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 3 months prior to screening;
21. Any condition that the investigator believes may increase the risk to the patient or interfere with the execution of the clinical trial;
22. Known allergy to any component of the investigational drug or its excipients, or a history of hypersensitivity (e.g., allergic to two or more drugs);
23. Any other disease or condition that, in the investigator's opinion, makes the patient 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: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Patients in this group will receive basal treatment and placebo.	Drug: STSA-1002 Injection Placebo; Intravenous infusion
Experimental: Low dose group; Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002.	Drug: STSA-1002 Injection Placebo; Intravenous infusion; Drug: STSA-1002 Injection; Intravenous infusion
Experimental: High dose group; Patients in this group will receive basal treatment and High-dose STSA-1002.	Drug: STSA-1002 Injection; Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical remission time	Baseline to Day28

Secondary Outcome Measures

Outcome Measure	Time Frame
28-day all-cause mortality rate	Day28 after first dose
Proportion of subjects achieving clinical remission on Day 14 and Day 28	Day14, Day28 after first dose
Changes in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14	Day3, Day5, Day7, Day10, Day14 after first dose
Change rates in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14	Day3, Day5, Day7, Day10, Day14 after first dose
Proportion of subjects with a decrease in the level of respiratory support by ≥1 grade on Day 28	Day28 after first dose
ICU length of stay and total hospitalization time on Day 28 (V10)	Day28 after first dose
Proportion of subjects discharged from the ICU on Day 28	Day28 after first dose
Proportion of subjects with PaO2/FiO2 > 300 mmHg on Day 28±2 (V10)	Day28 after first dose
Time without ventilator use (invasive or non-invasive) within 28 days	Day28 after first dose
Proportion of subjects alive and not receiving mechanical ventilation on Day 28	Day28 after first dose

Collaborators and Investigators

• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Investigators: Principal Investigator: Bin Cao, Ph.D, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2023
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): April 27, 2025

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: STSA-1002-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No