Back to resultsTo Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
STSA-1002 Injection Placebo
STSA-1002 Injection
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome
Eligibility Criteria
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.
Sites / Locations
- China-Japan Friendship Hospital
- Jinan Central Hospital
- Zibo Municipal Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo group
Low dose group
High dose group
Arm Description
Patients in this group will receive basal treatment and placebo.
Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002.
Patients in this group will receive basal treatment and High-dose STSA-1002.
Outcomes
Primary Outcome Measures
Clinical remission time
Secondary Outcome Measures
Full Information
NCT ID
NCT06038916
First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT06038916
Brief Title
To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients in this group will receive basal treatment and placebo.
Arm Title
Low dose group
Arm Type
Experimental
Arm Description
Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002.
Arm Title
High dose group
Arm Type
Experimental
Arm Description
Patients in this group will receive basal treatment and High-dose STSA-1002.
Intervention Type
Drug
Intervention Name(s)
STSA-1002 Injection Placebo
Intervention Description
Intravenous infusion
Intervention Type
Drug
Intervention Name(s)
STSA-1002 Injection
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
Clinical remission time
Time Frame
Baseline to Day30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luocheng Xu
Phone
13971452177
Email
xuluocheng@staidson.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Cao, Ph.D
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Cao
Phone
13911318339
Email
caobin_ben@163.com
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang
Phone
13370582931
Email
wangxinconnie@163.com
Facility Name
Zibo Municipal Hospital
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijun Suo
Phone
17660292282
Email
suolij@sina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
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