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/NCT05966701</url>
    </required_header>
    <id_info>
      <org_study_id>SSGJ-613-HH-I-02</org_study_id>
      <nct_id>NCT05966701</nct_id>
    </id_info>
    <brief_title>The MAD Study of SSGJ-613 in Healthy Subjects</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalation Phase I Clinical Study of Humanized Monoclonal Antibody Injection (SSGJ-613) in Healthy Adult Chinese Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sunshine Guojian Pharmaceutical (Shanghai) 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 tolerability of SSGJ-613 after multiple subcutaneous injections in&#xD;
        healthy subjects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purposes of this study are to evaluate the safety and tolerability, PK characteristics&#xD;
        and immunogenicity of SSGJ-613 after multiple subcutaneous injections in healthy subjects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">March 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 10, 2024</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.</measure>
      <time_frame>Up to Day 174</time_frame>
      <description>The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc..</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SSGJ-613 Concentration in Serum</measure>
      <time_frame>Up to Day 174</time_frame>
      <description>The concentration of SSGJ-613 in Serum.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Arthritis, Gouty</condition>
    <arm_group>
      <arm_group_label>SSGJ-613</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SSGJ-613，SC</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo, SC</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SSGJ-613</intervention_name>
      <description>SSGJ-613 subcutaneous injection.</description>
      <arm_group_label>SSGJ-613</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo subcutaneous injection.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Chinese healthy participants, male or female, aged 18 to 45 (including both ends)&#xD;
  &#xD;
            2. The body mass index (BMI) is in the range of 19.0~28.0 kg•m-2 (including both ends),&#xD;
               and the weight of men is generally not less than 50kg, while the women is generally&#xD;
               not less than 45kg&#xD;
  &#xD;
            3. Participants should fully understand the purpose, nature, methods and possible adverse&#xD;
               reactions of the trial, volunteer to participate in the trial and sign the informed&#xD;
               consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Those who are allergic to the study drug and any of its excipients. Subjects who have&#xD;
               a history of allergy to monoclonal antibodies&#xD;
  &#xD;
            2. Subjects who have or are currently suffering from any serious clinical diseases before&#xD;
               screening,&#xD;
  &#xD;
            3. Abnormal vital signs or abnormal ECGor physical examination are clinically significant&#xD;
  &#xD;
            4. Clinical laboratory examinations found to be abnormal and have clinical significance&#xD;
  &#xD;
            5. Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb),&#xD;
               anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)&#xD;
  &#xD;
            6. Alcoholics or frequent drinkers within 3 months before the trial, drinking more than&#xD;
               14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits or 150 mL wine), or&#xD;
               those who have a positive alcohol breath test (screening period or baseline period) or&#xD;
               couldn't prohibit alcohol during the trial&#xD;
  &#xD;
            7. Drug abusers or those who have used soft drugs (such as marijuana) within 3 months or&#xD;
               took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial,&#xD;
               or have positive drug abuse screening&#xD;
  &#xD;
            8. Has taken any prescription medicine, non-prescription medicine, Chinese patent&#xD;
               medicine within 2 weeks before administration&#xD;
  &#xD;
            9. Has known or suspected pregnancy or lactation&#xD;
  &#xD;
           10. Subjects who are unsuited to the study for any reason, judged by the investigators&#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_official>
      <last_name>Qinghong Zhou, BS</last_name>
      <role>Study Director</role>
      <affiliation>Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Qian Chen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Xuhui District Central Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qinghong Zhou, BS</last_name>
      <phone>+86 18911301578</phone>
      <email>zhouqinghong@3sbio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai Xuhui District Central Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200031</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qian Chen, PhD</last_name>
        <phone>021-54030254</phone>
        <email>qchen@shxh-centerlab.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 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>Arthritis, Gouty</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/NCT05966701
  org study id: SSGJ-613-HH-I-02
  nct id: NCT05966701
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the safety and tolerability of SSGJ-613 after multiple subcutaneous injections in
        healthy subjects.
  The purposes of this study are to evaluate the safety and tolerability, PK characteristics
        and immunogenicity of SSGJ-613 after multiple subcutaneous injections in healthy subjects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
  time frame: Up to Day 174
  description: The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc..
  measure: SSGJ-613 Concentration in Serum
  time frame: Up to Day 174
  description: The concentration of SSGJ-613 in Serum.
  arm group label: SSGJ-613
  arm group type: Experimental
  description: SSGJ-613，SC
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo, SC
  intervention type: Drug
  intervention name: SSGJ-613
  description: SSGJ-613 subcutaneous injection.
  arm group label: SSGJ-613
  intervention type: Drug
  intervention name: Placebo
  description: Placebo subcutaneous injection.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Qinghong Zhou, BS
  role: Study Director
  affiliation: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
  last name: Qian Chen, PhD
  role: Principal Investigator
  affiliation: Shanghai Xuhui District Central Hospital
  last name: Qinghong Zhou, BS
  phone: +86 18911301578
  email: zhouqinghong@3sbio.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Arthritis, Gouty
  sharing ipd: No