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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038916
• Other study ID #: STSA-1002-04
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 9, 2023
• Est. completion date: September 2026

Study information

• Verified date: September 2023
• Source: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Contact: Luocheng Xu
• Phone: 13971452177
• Email: xuluocheng[@]staidson.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 18 years old=Age=85 years old;

• In 14 days since the onset of respiratory infective symptoms (in 12 days for non-invasive mechanical ventilation patients);

• The nearest PaO2/FiO2=200mmHg;

• Low peripheral blood lymphocyte count;

• Patients (including patients' partners) did not plan to have children during the trial period and for 4 months after the end of the last dose and agreed to use appropriate and effective contraceptive methods;

Exclusion Criteria:

• Use ECMO before first administration;

• The time between first administration and invasive mechanical ventilation was more than 48h;

• Survival is expected to be no more than 24 hours or a cardiac arrest has occurred 4 weeks before screening;

• Vital organs failure, including the liver, kidneys and heart;

• Immunosuppressed state;

• Serious underlying disease.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• STSA-1002 Injection Placebo
Intravenous infusion
• STSA-1002 Injection
Intravenous infusion

Locations

Country	Name	City	State
China	Beijing Luhe Hospital affiliated to Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Chengdu Fifth People's Hospital	Chengdu	Sichuan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital of Chengdu Medical College	Chengdu	Sichuan
China	The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University	Chongqing	Chongqing
China	Hangzhou Red Cross Hospital	Hangzhou	Zhejiang
China	Jinan Central Hospital	Jinan	Shandong
China	Huaihe Hospital of Henan University	Kaifeng	Henan
China	Zhongda Hospital affiliated to Southeast University	Nanjing	Jiangsu
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Renji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Wuhan Jinyintan Hospital	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Xiangtan Central Hospital	Xiangtan	Hunan
China	The First Affiliated Hospital of Xinxiang Medical College	Xingxiang	Henan
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	Zibo Municipal Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Staidson (Beijing) Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission time		Baseline to Day30