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/NCT06022536</url>
    </required_header>
    <id_info>
      <org_study_id>SYSS-SSS40-UND-I-01</org_study_id>
      <nct_id>NCT06022536</nct_id>
    </id_info>
    <brief_title>A Clinical Study of SSS40 in Healthy Chinese Volunteers</brief_title>
    <official_title>SSS40 A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study of Single-dose, Dose-escalation Safety, Tolerability, Pharmacokinetics, and Immunogenicity in Healthy Chinese Subjects.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Affiliated Hospital of Qingdao University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Affiliated Hospital of Qingdao University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-center, randomized, double-blind, single-administration, escalating-dose,&#xD;
        placebo-controlled, phase I clinical trial to evaluate the safety, tolerability,&#xD;
        pharmacokinetics, and immunogenicity of SSS40 in healthy subjects in China.&#xD;
  &#xD;
        A total of 8 subcutaneous dose groups were planned, including 1mg, 3mg, 10mg, 20mg, 30mg,&#xD;
        45mg, 60mg, 80mg. Starting from the 10mg group, a sentinel approach was adopted, whereby 2&#xD;
        subjects were first enrolled in the group, and randomized to the sentinel group in a 1:1&#xD;
        ratio (test drug:placebo), with the sentinels blinded, and then the remaining subjects in the&#xD;
        group were randomized according to a 1:1 ratio (test drug:placebo), and the sentinel group&#xD;
        was blinded. After completion of the 72-h safety assessment in the sentinel group, the&#xD;
        remaining subjects in the group were randomized to receive the drug according to the test&#xD;
        drug group and the placebo group.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">July 12, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 26, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>Single-dose , dose escalation, placebo-controlled study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</measure>
      <time_frame>up to 57 days</time_frame>
      <description>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Peak Plasma Concentration (Cmax)</measure>
      <time_frame>up to 57 days</time_frame>
      <description>Evaluation of Peak Plasma Concentration (Cmax)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the plasma concentration versus time curve (AUC)0-t</measure>
      <time_frame>up to 57 days</time_frame>
      <description>Evaluation of Area under the plasma concentration versus time curve (AUC)0-t</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the plasma concentration versus time curve (AUC)0-∞</measure>
      <time_frame>up to 57 days</time_frame>
      <description>Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">69</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>1mg dose group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The 1mg dose group is a low dose group and only safety and tolerability will be evaluated, pharmacokinetics and immunogenicity will not be evaluated, therefore one subject is planned to be enrolled.1mg SSS40 was injected subcutaneously on day1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3mg dose group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Four subjects were included in the 3mg dose group (trial group: 3:1 placebo group).3mg SSS40/Placebo was injected subcutaneously on day1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>10mg、20mg、30mg、 45mg、60mg or 80mg dose group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sentinel dosing was used starting with the 10 mg group, with two subjects first enrolled and randomized 1:1 (test drug:placebo) for sentinel dosing, with sentinels participating in blinding, and then after the sentinel group had completed the 72-h safety assessment, the rest of the subjects in the group were randomized to receive dosing according to the test drug group versus the placebo group.10mg、20mg、30mg、 45mg、60mg or 80mg SSS40/Placebo was injected subcutaneously on day1.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SSS40</intervention_name>
      <description>Subjects injected with SSS40</description>
      <arm_group_label>10mg、20mg、30mg、 45mg、60mg or 80mg dose group</arm_group_label>
      <arm_group_label>1mg dose group</arm_group_label>
      <arm_group_label>3mg dose group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Subjects injected with Placebo</description>
      <arm_group_label>10mg、20mg、30mg、 45mg、60mg or 80mg dose group</arm_group_label>
      <arm_group_label>3mg dose group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Signed an informed consent form prior to the trial, volunteered to participate in the&#xD;
               trial, and was willing and able to follow the study protocol for medications, tests,&#xD;
               visits, and other related procedures;&#xD;
  &#xD;
            -  At the time of signing the informed consent form, the age of 18-45 years old&#xD;
               (including both sides of the border), the proportion of female subjects is not less&#xD;
               than 1/3 of the sample in the group;&#xD;
  &#xD;
            -  Men weighing not less than 50kg and women weighing not less than 45kg, with BMI within&#xD;
               the range of 19.0~26.0 (both sides included) [BMI=Weight (kg)/Height (m2)]；&#xD;
  &#xD;
            -  Those who have no abnormalities or whose abnormalities are not clinically significant&#xD;
               after assessment of vital signs, physical examination, routine blood, urine, blood&#xD;
               biochemistry, coagulation, pregnancy test (women of childbearing age), 12-lead&#xD;
               electrocardiogram (ECG), abdominal B-ultrasound, and thyroid function at the time of&#xD;
               screening;&#xD;
  &#xD;
            -  Subjects and their spouses or partners do not plan to have children or donate&#xD;
               sperm/eggs and are willing to use reliable contraception or are not of childbearing&#xD;
               potential from the time of initiation of study drug use (14 days prior to study drug&#xD;
               use for females) through 6 months post-dose. The female subject is not lactating and&#xD;
               has a negative pregnancy test.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior history of allergies or sensitivities；&#xD;
  &#xD;
            -  Diseases or factors with abnormal clinical manifestations, including, but not limited&#xD;
               to, neurological, cardiovascular, hematologic, hepatic cardiovascular, hematologic,&#xD;
               hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune, skeletal&#xD;
               system diseases or other factors. other factors；&#xD;
  &#xD;
            -  History of bone or joint disease, including but not limited to osteoarthritis,&#xD;
               avascular necrosis, destructive joint disease, pathologic fractures, osteonecrosis,&#xD;
               rheumatoid arthritis, lupus erythematosus or arthritis, pathologic fractures,&#xD;
               osteonecrosis, rheumatoid arthritis, neuropathic arthritis, lupus erythematosus, or&#xD;
               Inflammatory Joint Diseases；&#xD;
  &#xD;
            -  History of joint-related events, including but not limited to joint trauma, total&#xD;
               joint replacement, meniscus or knee ligament injury (with or without surgical repair),&#xD;
               joint infection, joint dislocation total joint replacement, meniscus or knee ligament&#xD;
               injuries (with or without surgical repair), joint infections, joint dislocations etc.&#xD;
  &#xD;
            -  Those with a history of clinically significant peripheral neuropathy, sensory&#xD;
               abnormalities, and dullness of sensation；&#xD;
  &#xD;
            -  Those with a history of autonomic neuropathy or diabetic neuropathy；&#xD;
  &#xD;
            -  Those who have undergone surgery within 3 months prior to screening or are scheduled&#xD;
               for surgery during the trial period；&#xD;
  &#xD;
            -  Use of any prescription drugs, over-the-counter drugs, and supplements within 2 weeks&#xD;
               prior to screening；&#xD;
  &#xD;
            -  Average daily smoking ≥5 cigarettes or equivalent in the 3 months prior to screening；&#xD;
  &#xD;
            -  Average weekly alcohol consumption in the 3 months prior to screening of more than 14&#xD;
               Alcohol Units (1 Alcohol Unit is equivalent to. 360 ml of beer or 45 ml of 40% alcohol&#xD;
               by volume spirits or 150 ml of red wine) or a positive breath alcohol result Positive；&#xD;
  &#xD;
            -  Those vaccinated within 4 weeks prior to screening or scheduled to be vaccinated&#xD;
               during the study or within 4 weeks of the end of the trial；&#xD;
  &#xD;
            -  Those who have participated in a clinical trial of any drug and used the test drug&#xD;
               within 3 months prior to screening；&#xD;
  &#xD;
            -  Participated in blood donation or large blood loss (≥200 ml) within 3 months before&#xD;
               screening；&#xD;
  &#xD;
            -  Those with known factors that significantly interfere with normal venous blood&#xD;
               collection, such as a history of needle or blood fainting；&#xD;
  &#xD;
            -  Those with a positive urine drug screening test；&#xD;
  &#xD;
            -  Persons with a known history of substance abuse and/or drug intake.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yu Cao, doctor</last_name>
      <phone>86-18661809090</phone>
      <email>caoyu1767@126.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Affiliated Hospital of Qingdao University</investigator_affiliation>
      <investigator_full_name>Cao Yu</investigator_full_name>
      <investigator_title>Director of Clinical Trials Center of Affiliated Hospital of Qingdao University</investigator_title>
    </responsible_party>
    <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/NCT06022536
  org study id: SYSS-SSS40-UND-I-01
  nct id: NCT06022536
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-center, randomized, double-blind, single-administration, escalating-dose,
        placebo-controlled, phase I clinical trial to evaluate the safety, tolerability,
        pharmacokinetics, and immunogenicity of SSS40 in healthy subjects in China.
  
        A total of 8 subcutaneous dose groups were planned, including 1mg, 3mg, 10mg, 20mg, 30mg,
        45mg, 60mg, 80mg. Starting from the 10mg group, a sentinel approach was adopted, whereby 2
        subjects were first enrolled in the group, and randomized to the sentinel group in a 1:1
        ratio (test drug:placebo), with the sentinels blinded, and then the remaining subjects in the
        group were randomized according to a 1:1 ratio (test drug:placebo), and the sentinel group
        was blinded. After completion of the 72-h safety assessment in the sentinel group, the
        remaining subjects in the group were randomized to receive the drug according to the test
        drug group and the placebo group.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: Single-dose , dose escalation, placebo-controlled study
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
  time frame: up to 57 days
  description: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
  measure: Peak Plasma Concentration (Cmax)
  time frame: up to 57 days
  description: Evaluation of Peak Plasma Concentration (Cmax)
  measure: Area under the plasma concentration versus time curve (AUC)0-t
  time frame: up to 57 days
  description: Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
  measure: Area under the plasma concentration versus time curve (AUC)0-∞
  time frame: up to 57 days
  description: Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
  arm group label: 1mg dose group
  arm group type: Experimental
  description: The 1mg dose group is a low dose group and only safety and tolerability will be evaluated, pharmacokinetics and immunogenicity will not be evaluated, therefore one subject is planned to be enrolled.1mg SSS40 was injected subcutaneously on day1.
  arm group label: 3mg dose group
  arm group type: Experimental
  description: Four subjects were included in the 3mg dose group (trial group: 3:1 placebo group).3mg SSS40/Placebo was injected subcutaneously on day1.
  arm group label: 10mg、20mg、30mg、 45mg、60mg or 80mg dose group
  arm group type: Experimental
  description: Sentinel dosing was used starting with the 10 mg group, with two subjects first enrolled and randomized 1:1 (test drug:placebo) for sentinel dosing, with sentinels participating in blinding, and then after the sentinel group had completed the 72-h safety assessment, the rest of the subjects in the group were randomized to receive dosing according to the test drug group versus the placebo group.10mg、20mg、30mg、 45mg、60mg or 80mg SSS40/Placebo was injected subcutaneously on day1.
  intervention type: Drug
  intervention name: SSS40
  description: Subjects injected with SSS40
  arm group label: 10mg、20mg、30mg、 45mg、60mg or 80mg dose group
  arm group label: 1mg dose group
  arm group label: 3mg dose group
  intervention type: Drug
  intervention name: Placebo
  description: Subjects injected with Placebo
  arm group label: 10mg、20mg、30mg、 45mg、60mg or 80mg dose group
  arm group label: 3mg dose group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yu Cao, doctor
  phone: 86-18661809090
  email: caoyu1767@126.com
  responsible party type: Principal Investigator
  investigator affiliation: The Affiliated Hospital of Qingdao University
  investigator full name: Cao Yu
  investigator title: Director of Clinical Trials Center of Affiliated Hospital of Qingdao University
  sharing ipd: No