xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06038916</url>
    </required_header>
    <id_info>
      <org_study_id>STSA-1002-04</org_study_id>
      <nct_id>NCT06038916</nct_id>
    </id_info>
    <brief_title>To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Staidson (Beijing) Biopharmaceuticals Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Staidson (Beijing) Biopharmaceuticals Co., Ltd</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute&#xD;
        respiratory distress syndrome.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical remission time</measure>
      <time_frame>Baseline to Day30</time_frame>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Acute Respiratory Distress Syndrome</condition>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients in this group will receive basal treatment and placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low dose group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High dose group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in this group will receive basal treatment and High-dose STSA-1002.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>STSA-1002 Injection Placebo</intervention_name>
      <description>Intravenous infusion</description>
      <arm_group_label>Low dose group</arm_group_label>
      <arm_group_label>Placebo group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>STSA-1002 Injection</intervention_name>
      <description>Intravenous infusion</description>
      <arm_group_label>High dose group</arm_group_label>
      <arm_group_label>Low dose group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years old≤Age≤85 years old;&#xD;
  &#xD;
            -  In 14 days since the onset of respiratory infective symptoms (in 12 days for&#xD;
               non-invasive mechanical ventilation patients);&#xD;
  &#xD;
            -  The nearest PaO2/FiO2≤200mmHg;&#xD;
  &#xD;
            -  Low peripheral blood lymphocyte count;&#xD;
  &#xD;
            -  Patients (including patients' partners) did not plan to have children during the trial&#xD;
               period and for 4 months after the end of the last dose and agreed to use appropriate&#xD;
               and effective contraceptive methods;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use ECMO before first administration;&#xD;
  &#xD;
            -  The time between first administration and invasive mechanical ventilation was more&#xD;
               than 48h;&#xD;
  &#xD;
            -  Survival is expected to be no more than 24 hours or a cardiac arrest has occurred 4&#xD;
               weeks before screening;&#xD;
  &#xD;
            -  Vital organs failure, including the liver, kidneys and heart;&#xD;
  &#xD;
            -  Immunosuppressed state;&#xD;
  &#xD;
            -  Serious underlying disease.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bin Cao, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>China-Japan Friendship Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Luocheng Xu</last_name>
      <phone>13971452177</phone>
      <email>xuluocheng@staidson.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>China-Japan Friendship Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100029</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Bin Cao</last_name>
        <phone>13911318339</phone>
        <email>caobin_ben@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jinan Central Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250013</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xin Wang</last_name>
        <phone>13370582931</phone>
        <email>wangxinconnie@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Zibo Municipal Hospital</name>
        <address>
          <city>Zibo</city>
          <state>Shandong</state>
          <zip>255000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Lijun Suo</last_name>
        <phone>17660292282</phone>
        <email>suolij@sina.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Distress Syndrome</mesh_term>
      <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
      <mesh_term>Acute Lung Injury</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06038916
  org study id: STSA-1002-04
  nct id: NCT06038916
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute
        respiratory distress syndrome.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Clinical remission time
  time frame: Baseline to Day30
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: Patients in this group will receive basal treatment and placebo.
  arm group label: Low dose group
  arm group type: Experimental
  description: Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002.
  arm group label: High dose group
  arm group type: Experimental
  description: Patients in this group will receive basal treatment and High-dose STSA-1002.
  intervention type: Drug
  intervention name: STSA-1002 Injection Placebo
  description: Intravenous infusion
  arm group label: Low dose group
  arm group label: Placebo group
  intervention type: Drug
  intervention name: STSA-1002 Injection
  description: Intravenous infusion
  arm group label: High dose group
  arm group label: Low dose group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Bin Cao, Ph.D
  role: Principal Investigator
  affiliation: China-Japan Friendship Hospital
  last name: Luocheng Xu
  phone: 13971452177
  email: xuluocheng@staidson.com
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Respiratory Distress Syndrome
  mesh term: Respiratory Distress Syndrome, Newborn
  mesh term: Acute Lung Injury
  mesh term: Syndrome
  sharing ipd: No