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/NCT06009094</url>
    </required_header>
    <id_info>
      <org_study_id>YQ-M-23-02</org_study_id>
      <nct_id>NCT06009094</nct_id>
    </id_info>
    <brief_title>Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis</brief_title>
    <official_title>Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jiangsu vcare pharmaceutical technology co., LTD</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jiangsu vcare pharmaceutical technology co., LTD</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 study is a single center, randomized, double-blind, Vehicle controlled,, single and&#xD;
        multiple dose clinical study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Peak Plasma Concentration (Cmax）</measure>
      <time_frame>Day2,Day 4,Day17,Day31</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in EASI（Eczema area and severity index） from baseline</measure>
      <time_frame>Week 2,Week 4</time_frame>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Atopic Dermatitis</condition>
    <arm_group>
      <arm_group_label>VC005 Low Dose groups</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>VC005 median-A Dose groups</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>VC005 median-B Dose groups</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>VC005 high Dose groups</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>VC005 Placebo groups</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VC005</intervention_name>
      <description>VC005 group with Local topical application</description>
      <arm_group_label>VC005 Low Dose groups</arm_group_label>
      <arm_group_label>VC005 high Dose groups</arm_group_label>
      <arm_group_label>VC005 median-A Dose groups</arm_group_label>
      <arm_group_label>VC005 median-B Dose groups</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VC005 Placebo</intervention_name>
      <description>VC005 Placebo group with Local topical application</description>
      <arm_group_label>VC005 Placebo groups</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          healthy subject's study:&#xD;
  &#xD;
            1. Healthy male or female subjects, aged 18-45 years (including critical values);&#xD;
  &#xD;
            2. Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male&#xD;
               weight ≥ 50kg and female weight ≥ 45kg;&#xD;
  &#xD;
            3. All women and men with fertility potential must be willing to use at least one&#xD;
               efficient method of contraception from the signing of the informed consent form until&#xD;
               3 months after the last administration of the study drug, as detailed in Appendix 5;&#xD;
  &#xD;
            4. Voluntarily participate in the experiment and sign an informed consent form;&#xD;
  &#xD;
            5. Subjects who are able to communicate well with the researcher and are willing and able&#xD;
               to comply with all planned visits, treatment plans, laboratory tests, and other&#xD;
               research procedures&#xD;
  &#xD;
          patient's study:&#xD;
  &#xD;
            1. When informed consent is given, the age range is between 18 and 75 years (including&#xD;
               the boundary value), regardless of gender;&#xD;
  &#xD;
            2. Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male&#xD;
               weight ≥ 50kg and female weight ≥ 45kg;&#xD;
  &#xD;
            3. Before administration, the diagnosis of mild to moderate atopic dermatitis should be&#xD;
               met:&#xD;
  &#xD;
               Overall Investigator Assessment (IGA) score of 2 to 3 points; Atopic dermatitis: total&#xD;
               area of skin lesions 3% ≤ body surface area≤ 20%&#xD;
  &#xD;
            4. Voluntarily sign an informed consent form (with a date), indicating that the subject&#xD;
               has been informed of all relevant parts of the study;&#xD;
  &#xD;
            5. All women and men with the possibility of childbirth must be willing to use at least&#xD;
               one efficient method of contraception from the signing of the informed consent form&#xD;
               until 3 months after the last administration of the study drug, as detailed in&#xD;
               Appendix 5;&#xD;
  &#xD;
            6. Subjects who are willing and able to comply with planned visits and treatment plans,&#xD;
               laboratory tests, and other research procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          healthy subject's study:&#xD;
  &#xD;
            1. Suspected of being allergic to the study drug or any component of the study drug, or&#xD;
               having an allergic constitution;&#xD;
  &#xD;
            2. Those who have received the vaccine within 2 weeks before administration or plan to&#xD;
               receive the vaccine during the study period;&#xD;
  &#xD;
            3. Screening for individuals who have undergone any surgery within the previous 6 months;&#xD;
  &#xD;
            4. Those who participated in blood donation within the first 3 months of screening and&#xD;
               had a blood donation volume of ≥ 400 mL, or received blood transfusion (excluding&#xD;
               female physiological blood loss);&#xD;
  &#xD;
            5. Female subjects of childbearing age had unprotected sexual intercourse with their&#xD;
               opposite sex partner within 14 days prior to screening;&#xD;
  &#xD;
            6. Screening of clinical trial participants (including excipient groups) who have&#xD;
               participated in any drug or medical device within the first 3 months;&#xD;
  &#xD;
            7. Pregnant and lactating women;&#xD;
  &#xD;
            8. Patients with difficulty in blood collection or inability to tolerate venous puncture,&#xD;
               and those with a history of needle and blood fainting;&#xD;
  &#xD;
            9. Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, and&#xD;
               cannot stop using any tobacco products from the end of screening to enrollment and&#xD;
               during the trial period;&#xD;
  &#xD;
           10. Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈&#xD;
               360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of&#xD;
               screening, or who cannot abstain from alcohol during the trial period;&#xD;
  &#xD;
           11. Other situations where the researcher determines that it is not suitable to&#xD;
               participate in the experiment.&#xD;
  &#xD;
          patient's study:&#xD;
  &#xD;
            1. Suspected of being allergic to the study drug or any component of the study drug, or&#xD;
               having an allergic constitution;&#xD;
  &#xD;
            2. Those who have received the vaccine within 2 weeks before administration or plan to&#xD;
               receive the vaccine during the study period;&#xD;
  &#xD;
            3. Screening for individuals who have undergone any surgery within the previous 6 months;&#xD;
  &#xD;
            4. Those who participated in blood donation within the first 3 months of screening and&#xD;
               had a blood donation volume of ≥ 400 mL, or received blood transfusion (excluding&#xD;
               female physiological blood loss);&#xD;
  &#xD;
            5. Screening of clinical trial participants (including excipient groups) who have&#xD;
               participated in any drug or medical device within the first 3 months;&#xD;
  &#xD;
            6. Pregnant and lactating women;&#xD;
  &#xD;
            7. Patients with difficulty in blood collection or inability to tolerate venous puncture,&#xD;
               and those with a history of needle and blood fainting;&#xD;
  &#xD;
            8. Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, and&#xD;
               cannot stop using any tobacco products from the end of screening to enrollment and&#xD;
               during the trial period;&#xD;
  &#xD;
            9. Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈&#xD;
               360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of&#xD;
               screening, or who cannot abstain from alcohol during the trial period;&#xD;
  &#xD;
           10. Other situations where the researcher determines that it is not suitable to&#xD;
               participate in the experiment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Qianjin Lu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chinese Academy of Medical Sciences Hospital of Skin Disease</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaojuan Lai</last_name>
      <phone>15358160458</phone>
      <email>lai_xiaojuan@vcarepharmatech.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 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>Dermatitis, Atopic</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Eczema</mesh_term>
    </condition_browse>
    <!-- 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/NCT06009094
  org study id: YQ-M-23-02
  nct id: NCT06009094
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a single center, randomized, double-blind, Vehicle controlled,, single and
        multiple dose clinical study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Peak Plasma Concentration (Cmax）
  time frame: Day2,Day 4,Day17,Day31
  measure: Changes in EASI（Eczema area and severity index） from baseline
  time frame: Week 2,Week 4
  arm group label: VC005 Low Dose groups
  arm group type: Experimental
  arm group label: VC005 median-A Dose groups
  arm group type: Experimental
  arm group label: VC005 median-B Dose groups
  arm group type: Experimental
  arm group label: VC005 high Dose groups
  arm group type: Experimental
  arm group label: VC005 Placebo groups
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: VC005
  description: VC005 group with Local topical application
  arm group label: VC005 Low Dose groups
  arm group label: VC005 high Dose groups
  arm group label: VC005 median-A Dose groups
  arm group label: VC005 median-B Dose groups
  intervention type: Drug
  intervention name: VC005 Placebo
  description: VC005 Placebo group with Local topical application
  arm group label: VC005 Placebo groups
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Qianjin Lu
  role: Principal Investigator
  affiliation: Chinese Academy of Medical Sciences Hospital of Skin Disease
  last name: Xiaojuan Lai
  phone: 15358160458
  email: lai_xiaojuan@vcarepharmatech.com
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Eczema