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/NCT06022354</url>
    </required_header>
    <id_info>
      <org_study_id>SIM0278-101</org_study_id>
      <nct_id>NCT06022354</nct_id>
    </id_info>
    <brief_title>To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 in Chinese Healthy Subjects</brief_title>
    <official_title>A Single-center, Randomized, Double-blind, Sponsor Open, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 After Single and Multiple Subcutaneous Injections in Chinese Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jiangsu Simcere Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jiangsu Simcere Pharmaceutical 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>
        This is a Phase 1, randomized, double-blind, placebo-controlled trial of SIM0278 in healthy&#xD;
        subjects. The study will be conducted in 2 parts. Part 1 is single ascending dose study. Part&#xD;
        2 is multiple ascending dose study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will assess the safety, tolerability, and pharmacokinetics（PK） after a single or&#xD;
        multiple administration of SIM0278 or placebo via subcutaneous injection in healthy subjects&#xD;
        (male or female) where PK, pharmacodynamics (PD) and biomarkers will be assessed.&#xD;
        Approximately 68 subjects (up to 84) will be enrolled in the whole study. The ratio of active&#xD;
        drug to placebo in each dose level will be 3:1. In part1, approximately 44 subjects (up to&#xD;
        52) will be enrolled for the single dose escalation. Six dose levels are planned in part 1.&#xD;
        In part2, approximately 24 (up to 32) subjects will be enrolled for the multiple dose&#xD;
        escalation. Three dose levels are planned in part 2.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 23, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) of subcutaneous injections of SIM0278 in healthy subjects after single dose (Part 1) or multiple dose (Part 2) administration</measure>
      <time_frame>Part 1:up to 29 days after the first dose of treatment; Part 2:up to 85 days after the first dose of treatment</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Peak plasma concentration(Cmax) of SIM0278 in serum</measure>
      <time_frame>Time Frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment</time_frame>
      <description>Cmax was measured for SIM0278 administered by subcutaneous injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to reach maximum concentration (Tmax) of SIM0278 in serum</measure>
      <time_frame>Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment</time_frame>
      <description>Tmax was measured for SIM0278 administered by subcutaneous injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the curve (AUC) of SIM0278in serum</measure>
      <time_frame>Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment</time_frame>
      <description>AUC was measured for SIM0278 administered by subcutaneous injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half life (T1/2) of SIM0278 in serum</measure>
      <time_frame>Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment</time_frame>
      <description>T1/2 was measured for SIM0278 administered by subcutaneous injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total body clearance (CL/F) of SIM0278 in serum</measure>
      <time_frame>Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment</time_frame>
      <description>CL/F was measured for SIM0278 administered by subcutaneous injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total volume of distribution（Vd） at the terminal phase of SIM0278 in serum</measure>
      <time_frame>Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment</time_frame>
      <description>Vd was measured for SIM0278 administered by subcutaneous injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of antidrug antibodies (ADA)</measure>
      <time_frame>Part 1:up to 29 days after the first dose of treatment; Part 2:up to 85 days after the first dose of treatment</time_frame>
      <description>The presence of ADAs to SIM0278 will be listed and summarized by treatment group</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Fold Change from Baseline in Regulatory T cells (Tregs)</measure>
      <time_frame>Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Fold Change from Baseline in Conventional CD4+ T Cells</measure>
      <time_frame>Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Fold Change from Baseline in Conventional CD8+ T Cells</measure>
      <time_frame>Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Fold Change from Baseline in Natural Killer (NK) Cells</measure>
      <time_frame>Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Change from Baseline in Treg Activation Markers: Cytokine Levels, Proliferation and Immunosuppressive Markers Expression</measure>
      <time_frame>Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>The correlation between SIM0278 dose/exposure and biomarkers or safety endpoints (if applicable) in healthy subjects</measure>
      <time_frame>Part 1:up to 29 days after the first dose of treatment; Part 2:up to 71 days after the first dose of treatment</time_frame>
    </other_outcome>
    <number_of_arms>11</number_of_arms>
    <enrollment type="Anticipated">84</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Part 1 : cohort 1: SIM0278 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1 : cohort 2: SIM0278 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1 : cohort 3: SIM0278 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1 : cohort 4: SIM0278 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1 : cohort 5: SIM0278 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1 : cohort 6: SIM0278 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1 : cohort 7: SIM0278 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2 : cohort 1: SIM0278 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2 : cohort 2: SIM0278 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2 : cohort 3: SIM0278 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2 : cohort 4: SIM0278 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SIM0278 Injection/Placebo</intervention_name>
      <description>SIM0278 Injection/Placebo</description>
      <arm_group_label>Part 1 : cohort 1: SIM0278 or placebo</arm_group_label>
      <arm_group_label>Part 1 : cohort 2: SIM0278 or placebo</arm_group_label>
      <arm_group_label>Part 1 : cohort 3: SIM0278 or placebo</arm_group_label>
      <arm_group_label>Part 1 : cohort 4: SIM0278 or placebo</arm_group_label>
      <arm_group_label>Part 1 : cohort 5: SIM0278 or placebo</arm_group_label>
      <arm_group_label>Part 1 : cohort 6: SIM0278 or placebo</arm_group_label>
      <arm_group_label>Part 1 : cohort 7: SIM0278 or placebo</arm_group_label>
      <arm_group_label>Part 2 : cohort 1: SIM0278 or placebo</arm_group_label>
      <arm_group_label>Part 2 : cohort 2: SIM0278 or placebo</arm_group_label>
      <arm_group_label>Part 2 : cohort 3: SIM0278 or placebo</arm_group_label>
      <arm_group_label>Part 2 : cohort 4: SIM0278 or placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject must be 18 to 55 years of age (inclusive), at the time of signing the informed&#xD;
               consent.&#xD;
  &#xD;
            2. Body Mass Index (BMI) ≥ 18 and ≤ 28 kg/m2 and weight at least 45 kg at screening.&#xD;
  &#xD;
            3. A condition of general good health, as determined by the investigator or medically&#xD;
               qualified designee based on a medical evaluation including medical history, physical&#xD;
               examination, vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) and&#xD;
               chest X-ray.&#xD;
  &#xD;
            4. A female subject is eligible to participate if she is not pregnant, not breastfeeding,&#xD;
               and at least one of the following conditions applies:&#xD;
  &#xD;
                 -  Not a woman of childbearing potential (WOCBP) as defined in, OR&#xD;
  &#xD;
                 -  A WOCBP who agrees to follow the contraceptive guidance in from screening through&#xD;
                    at least 90 days after the last dose of study drug; a WOCBP must have a negative&#xD;
                    beta-human chorionic gonadotropin (β-hCG) test at screening and baseline prior to&#xD;
                    administration of investigational product.&#xD;
  &#xD;
            5. A male subject must agree to use contraception as detailed in this protocol from&#xD;
               screening through at least 90 days after the last dose of study drug. Sperm donation&#xD;
               is also restricted during the time-frame that males must practice highly effective&#xD;
               method of contraception. This criterion may be waived for male subjects who have had a&#xD;
               vasectomy more than (&gt;) 90 days prior to screening.&#xD;
  &#xD;
            6. Must voluntarily sign and date each informed consent approved by an Independent Ethics&#xD;
               Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any&#xD;
               screening or study-specific procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of significant sensitivity to any drug or previous severe adverse reaction to&#xD;
               subcutaneous medication.&#xD;
  &#xD;
            2. Subject has a history of any clinically significant cardiac, respiratory (including&#xD;
               asthma, bronchospasm), renal, hepatic, gastrointestinal, psychiatric, neurologic,&#xD;
               hematologic or rheumatic disease, or psychiatric disease or disorder, current acute or&#xD;
               chronic infections, or other abnormality that may affect safety, or potentially&#xD;
               influence the study results, judged by the investigator.&#xD;
  &#xD;
            3. Chronic or active infection(s) requiring treatment with intravenous anti-infectives&#xD;
               within 4 weeks prior to the dose of study drug, or oral anti-infectives within 2 weeks&#xD;
               prior to Day 1, or positive test for novel coronavirus antigen or nucleic acid within&#xD;
               4 weeks prior to first dose&#xD;
  &#xD;
            4. Evidence or history of malignancy other than a successfully treated non-metastatic&#xD;
               cutaneous squamous cell or basal cell carcinoma.&#xD;
  &#xD;
            5. History of chronic or active hepatitis, or current positive result, including&#xD;
               hepatitis B or hepatitis C infection, as evidenced by a positive test for hepatitis B&#xD;
               surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).&#xD;
  &#xD;
            6. History of tuberculosis (TB), or active or latent TB on the basis of positive medical&#xD;
               history.&#xD;
  &#xD;
            7. History of or positive screening test for human immunodeficiency virus (HIV)&#xD;
               infection; any genetic, congenital, or acquired immunodeficiency syndrome, or any&#xD;
               chronic recurring infections (including mucocutaneous candidiasis).&#xD;
  &#xD;
            8. Systolic blood pressure (BP) ≥ 140 mmHg or ≤ 90 mmHg, or diastolic BP≥ 90 mmHg or ≤50&#xD;
               mm Hg, or HR &gt; 100 bpm, at Screening or baseline，and abnormal clinically significant&#xD;
               should be judged by the investigator&#xD;
  &#xD;
            9. Subjects with ANY of the following abnormalities in clinical laboratory tests at&#xD;
               screening:&#xD;
  &#xD;
                 -  Neutrophil or lymphocyte counts below the normal range; Eosinophil count above&#xD;
                    the normal range.&#xD;
  &#xD;
                 -  Estimated glomerular filtration rate (GFR) by Chronic Kidney Disease Epidemiology&#xD;
                    Collaboration equation (CKD-EPI) calculation ≤90 mL/min/1.73 m2 at screening.&#xD;
  &#xD;
                 -  Aspartate aminotransferase (AST)、Alanine transaminase (ALT) &gt;1.5 x upper limit of&#xD;
                    normal (ULN)&#xD;
  &#xD;
                 -  Total bilirubin &gt;1.2 x ULN&#xD;
  &#xD;
                 -  Other clinically significant abnormalities of laboratory assessments, as judged&#xD;
                    by the Investigator and/or sponsor Medical Monitor, that could affect the safety&#xD;
                    of the subject, or the interpretation of the data from the study.&#xD;
  &#xD;
           10. 12-lead ECG demonstrating QTcF≥450 msec（male）or QTcF≥470 msec（female） at Screening.&#xD;
               Subject who have II or III degree atrioventricular block or other clinically&#xD;
               significant electrocardiogram abnormalitieshas, in the opinion of the investigator,&#xD;
               are unsuitable subjects in the study.&#xD;
  &#xD;
           11. Use of prescription or non-prescription drugs (including recreational drugs and herbal&#xD;
               medications) within 14 days or 5 half-lives (whichever is longer) prior to Day 1&#xD;
               and/or within the duration of the study.&#xD;
  &#xD;
           12. Treatment with biologic agents (such as monoclonal antibodies including marketed&#xD;
               drugs) within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.&#xD;
  &#xD;
           13. Prior administration of any IL-2 based product.&#xD;
  &#xD;
           14. Exposure to immune-modulating medications (including topical or systemic use of&#xD;
               corticosteroids) within 4 weeks prior to Day 1.&#xD;
  &#xD;
           15. Receipt of any investigational product within 3 months or 5 half-lives (whichever is&#xD;
               longer) prior to Day 1.&#xD;
  &#xD;
           16. Will have live vaccine or attenuated live vaccine shots within the 12 weeks prior to&#xD;
               Day 1, or planning to receive these vaccines at any time during study period or within&#xD;
               8 weeks after last dose.&#xD;
  &#xD;
           17. Current or history of regular alcohol abuse（14 units of alcohol per week: 1 unit = 285&#xD;
               mL of beer, or 25 mL of spirits, or 100 mL of wine）within 6 months prior to day 1. OR&#xD;
               Positive screen for alcohol breath test during screening period.&#xD;
  &#xD;
           18. Take more than 10 cigarettes/day within the last 3 months prior to day 1, and/or&#xD;
               unwilling to stop using any tobacco products during the study duration.&#xD;
  &#xD;
           19. History of substance abuse, or a positive urine drug screen within 5 years prior to&#xD;
               Screening, or urine drug screening result is positive.&#xD;
  &#xD;
           20. Donation or loss of 400 mL or more blood volume (including plasmapheresis) or receipt&#xD;
               of a transfusion of any blood product within 8 weeks prior to Day 1.&#xD;
  &#xD;
           21. Consideration by the investigator, for any reason, that the subject is an unsuitable&#xD;
               candidate to enroll this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Affiliated Hospital of Qingdao University</name>
        <address>
          <city>Qingdao</city>
          <state>China, Shandong</state>
          <zip>266001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yu Cao, Doctor</last_name>
        <phone>+86-532-82911767</phone>
        <email>caoyu1767@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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/NCT06022354
  org study id: SIM0278-101
  nct id: NCT06022354
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a Phase 1, randomized, double-blind, placebo-controlled trial of SIM0278 in healthy
        subjects. The study will be conducted in 2 parts. Part 1 is single ascending dose study. Part
        2 is multiple ascending dose study.
  The study will assess the safety, tolerability, and pharmacokinetics（PK） after a single or
        multiple administration of SIM0278 or placebo via subcutaneous injection in healthy subjects
        (male or female) where PK, pharmacodynamics (PD) and biomarkers will be assessed.
        Approximately 68 subjects (up to 84) will be enrolled in the whole study. The ratio of active
        drug to placebo in each dose level will be 3:1. In part1, approximately 44 subjects (up to
        52) will be enrolled for the single dose escalation. Six dose levels are planned in part 1.
        In part2, approximately 24 (up to 32) subjects will be enrolled for the multiple dose
        escalation. Three dose levels are planned in part 2.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) of subcutaneous injections of SIM0278 in healthy subjects after single dose (Part 1) or multiple dose (Part 2) administration
  time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 85 days after the first dose of treatment
  measure: Peak plasma concentration(Cmax) of SIM0278 in serum
  time frame: Time Frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
  description: Cmax was measured for SIM0278 administered by subcutaneous injection
  measure: Time to reach maximum concentration (Tmax) of SIM0278 in serum
  time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
  description: Tmax was measured for SIM0278 administered by subcutaneous injection
  measure: Area under the curve (AUC) of SIM0278in serum
  time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
  description: AUC was measured for SIM0278 administered by subcutaneous injection
  measure: Half life (T1/2) of SIM0278 in serum
  time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
  description: T1/2 was measured for SIM0278 administered by subcutaneous injection
  measure: Total body clearance (CL/F) of SIM0278 in serum
  time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
  description: CL/F was measured for SIM0278 administered by subcutaneous injection
  measure: Total volume of distribution（Vd） at the terminal phase of SIM0278 in serum
  time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
  description: Vd was measured for SIM0278 administered by subcutaneous injection
  measure: Incidence of antidrug antibodies (ADA)
  time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 85 days after the first dose of treatment
  description: The presence of ADAs to SIM0278 will be listed and summarized by treatment group
  measure: Fold Change from Baseline in Regulatory T cells (Tregs)
  time frame: Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment
  measure: Fold Change from Baseline in Conventional CD4+ T Cells
  time frame: Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment
  measure: Fold Change from Baseline in Conventional CD8+ T Cells
  time frame: Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment
  measure: Fold Change from Baseline in Natural Killer (NK) Cells
  time frame: Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment
  measure: Change from Baseline in Treg Activation Markers: Cytokine Levels, Proliferation and Immunosuppressive Markers Expression
  time frame: Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment
  measure: The correlation between SIM0278 dose/exposure and biomarkers or safety endpoints (if applicable) in healthy subjects
  time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 71 days after the first dose of treatment
  arm group label: Part 1 : cohort 1: SIM0278 or placebo
  arm group type: Experimental
  arm group label: Part 1 : cohort 2: SIM0278 or placebo
  arm group type: Experimental
  arm group label: Part 1 : cohort 3: SIM0278 or placebo
  arm group type: Experimental
  arm group label: Part 1 : cohort 4: SIM0278 or placebo
  arm group type: Experimental
  arm group label: Part 1 : cohort 5: SIM0278 or placebo
  arm group type: Experimental
  arm group label: Part 1 : cohort 6: SIM0278 or placebo
  arm group type: Experimental
  arm group label: Part 1 : cohort 7: SIM0278 or placebo
  arm group type: Experimental
  arm group label: Part 2 : cohort 1: SIM0278 or placebo
  arm group type: Experimental
  arm group label: Part 2 : cohort 2: SIM0278 or placebo
  arm group type: Experimental
  arm group label: Part 2 : cohort 3: SIM0278 or placebo
  arm group type: Experimental
  arm group label: Part 2 : cohort 4: SIM0278 or placebo
  arm group type: Experimental
  intervention type: Drug
  intervention name: SIM0278 Injection/Placebo
  description: SIM0278 Injection/Placebo
  arm group label: Part 1 : cohort 1: SIM0278 or placebo
  arm group label: Part 1 : cohort 2: SIM0278 or placebo
  arm group label: Part 1 : cohort 3: SIM0278 or placebo
  arm group label: Part 1 : cohort 4: SIM0278 or placebo
  arm group label: Part 1 : cohort 5: SIM0278 or placebo
  arm group label: Part 1 : cohort 6: SIM0278 or placebo
  arm group label: Part 1 : cohort 7: SIM0278 or placebo
  arm group label: Part 2 : cohort 1: SIM0278 or placebo
  arm group label: Part 2 : cohort 2: SIM0278 or placebo
  arm group label: Part 2 : cohort 3: SIM0278 or placebo
  arm group label: Part 2 : cohort 4: SIM0278 or placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No