<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/NCT04445038</url>
  </required_header>
  <id_info>
    <org_study_id>SSGJ-610-HH-I-01</org_study_id>
    <nct_id>NCT04445038</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Injection</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Parallel Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-5 Humanized&#xD;
      Monoclonal Antibody injection in Healthy Subjects. There are 6 Groups as follows: 0.03mg/kg&#xD;
      (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2&#xD;
      subjects were included in the S1 group (both received study drugs); 10 subjects were included&#xD;
      in each of the S2 ~ S6 groups (of which 8 received study drugs and 2 received placebo).&#xD;
      Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance,&#xD;
      efficacy and immunogenicity for healthy subjects will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized, double-blind, placebo-controlled parallel trial of safety,&#xD;
      tolerability and pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody by&#xD;
      single subcutaneous injection with six different doses in healthy subjects. There are 6&#xD;
      groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5)&#xD;
      and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both received study drugs);&#xD;
      10 subjects were included in each of the S2 ~ S6 groups (of which 8 received study drugs and&#xD;
      2 received placebo). In each group, two subjects were sentinels (1 received the study drug&#xD;
      and 1 placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug&#xD;
      safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</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>Cmax</measure>
    <time_frame>up to 84 days</time_frame>
    <description>Maximum Plasma Concentration of 610</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>up to 84 days</time_frame>
    <description>Time to Maximum Plasma Concentration of 610</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>up to 84 days</time_frame>
    <description>Area Under the Curve of 610</description>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2</measure>
    <time_frame>up to 84 days</time_frame>
    <description>Half life of 610 in blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F</measure>
    <time_frame>up to 84 days</time_frame>
    <description>Plasma clearance of 610</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vd/F</measure>
    <time_frame>up to 84 days</time_frame>
    <description>Apparent Volume of Distribution of 610</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AE</measure>
    <time_frame>up to 84 days</time_frame>
    <description>To monitor adverse events (AEs) per the NCI CTCAE 5.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>up to 84 days</time_frame>
    <description>Percentage of ADA positive and determination of ADA titer as well as Nab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EOS</measure>
    <time_frame>up to 84 days</time_frame>
    <description>Compare the changes of EOS levels with the baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>add-on Maintenance Treatment of Patients With Severe Eosinophilic Asthma</condition>
  <arm_group>
    <arm_group_label>610 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered with 0.03mg/kg, 0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 5.0mg/kg, 7.5mg/kg of 610 by subcutaneous injection. Subjects will be followed for 84 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controll group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be administered with 0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 5.0mg/kg, 7.5mg/kg placebo once by subcutaneous injection. Subjects will be followed for 84 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>610</intervention_name>
    <description>Recombinant anti-IL-5 Humanized Monoclonal Antibody</description>
    <arm_group_label>610 group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>controll group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese healthy participants, male or female, aged 18 to 55 (including both ends)&#xD;
&#xD;
          -  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;
          -  Male participants and their partners or female participants must agree to take one or&#xD;
             more non-drug contraceptives (such as complete abstinence, contraceptive rings,&#xD;
             partner ligation, etc.) , and there is no sperm donation or egg donation plan&#xD;
&#xD;
          -  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;
          -  Participants could communicate well with the researchers and compliance with the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who are allergic to the study drug and any of its excipients. Subjects who have&#xD;
             a history of allergy to monoclonal antibodies, and with allergies (multiple drugs and&#xD;
             food allergies)&#xD;
&#xD;
          -  Subjects who have or are currently suffering from any serious clinical diseases such&#xD;
             as circulatory system, endocrine system, nervous system, digestive system, respiratory&#xD;
             system, urogenital system, hematology, immunology, psychiatry and metabolic&#xD;
             abnormalities or any other that can interfere with the study results&#xD;
&#xD;
          -  Those who have undergone surgery within the 3 months prior to the trial that will&#xD;
             affect the absorption, distribution, metabolism, and excretion of the drug; or those&#xD;
             who have undergone surgery within 4 weeks prior to the trial, or plan to undergo&#xD;
             surgery during the study&#xD;
&#xD;
          -  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;
          -  Alcoholics or frequent drinkers within 6 months before the trial, drinking more than&#xD;
             14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits with 40% alcohol&#xD;
             content or 150 mL wine), or couldn't prohibit alcohol during the trial or alcohol&#xD;
             breath test results greater than 0.0 mg / 100 mL&#xD;
&#xD;
          -  Those who smoked more than 5 cigarettes per day during the 3 months before screening,&#xD;
             or who cannot stop using any tobacco products during the trial&#xD;
&#xD;
          -  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 (morphine, methamphetamine , Ketamine, ecstasy,&#xD;
             marijuana)&#xD;
&#xD;
          -  Has taken any prescription medicine, non-prescription medicine, Chinese herbal&#xD;
             medicine or health products (vitamins, cod liver oil, etc.) within 14 days before&#xD;
             administration&#xD;
&#xD;
          -  Has received any monoclonal antibody drugs within 5 half-lives before administration&#xD;
&#xD;
          -  Has a history of vaccination within 4 weeks before dosing, or intend to receive&#xD;
             vaccines during the study&#xD;
&#xD;
          -  Has parasitic infection at present and within 3 months before dosing&#xD;
&#xD;
          -  Was previously enrolled in other clinical trials within 3 months&#xD;
&#xD;
          -  Blood donors or subjects who lost a lot of blood (&gt; 400 mL, except for women's&#xD;
             physiological period) or those who received blood transfusion or used blood products&#xD;
             within 3 months&#xD;
&#xD;
          -  Can't tolerate venipuncture or has a history of halo needles and halo blood&#xD;
&#xD;
          -  Has known or suspected pregnancy or lactation&#xD;
&#xD;
          -  Abnormal vital signs (SBP &lt;90 mmHg or ≥140 mmHg, DBP &lt;55 mmHg or ≥90 mmHg; heart rate&#xD;
             &lt;50 bpm or&gt; 100 bpm; body temperature (ear temperature) &lt;35.4℃ or &gt; 37.7℃) or abnormal&#xD;
             ECG (QTcB male ≥450 ms, female ≥460 ms) or physical examination, laboratory&#xD;
             examination, and abdominal ultrasound examination are clinically significant&#xD;
             (according to the judgment of clinical research doctors)&#xD;
&#xD;
          -  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>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xueying Ding, D.M.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xin Chou, B.M.</last_name>
    <phone>13701756821</phone>
    <email>13701756821@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xueying Ding, D.M.</last_name>
    <phone>13761642319</phone>
    <email>dingxueying@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai General Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xueying Ding, D.M.</last_name>
    </contact>
    <contact_backup>
      <last_name>Jigang Zhang</last_name>
      <phone>18621155781</phone>
      <email>grissomzhang@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</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>Pulmonary Eosinophilia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04445038
org study id: SSGJ-610-HH-I-01
nct id: NCT04445038
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-5 Humanized
      Monoclonal Antibody injection in Healthy Subjects. There are 6 Groups as follows: 0.03mg/kg
      (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2
      subjects were included in the S1 group (both received study drugs); 10 subjects were included
      in each of the S2 ~ S6 groups (of which 8 received study drugs and 2 received placebo).
      Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance,
      efficacy and immunogenicity for healthy subjects will be evaluated.
This study is a randomized, double-blind, placebo-controlled parallel trial of safety,
      tolerability and pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody by
      single subcutaneous injection with six different doses in healthy subjects. There are 6
      groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5)
      and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both received study drugs);
      10 subjects were included in each of the S2 ~ S6 groups (of which 8 received study drugs and
      2 received placebo). In each group, two subjects were sentinels (1 received the study drug
      and 1 placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug
      safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cmax
time frame: up to 84 days
description: Maximum Plasma Concentration of 610
measure: Tmax
time frame: up to 84 days
description: Time to Maximum Plasma Concentration of 610
measure: AUC
time frame: up to 84 days
description: Area Under the Curve of 610
measure: t1/2
time frame: up to 84 days
description: Half life of 610 in blood
measure: CL/F
time frame: up to 84 days
description: Plasma clearance of 610
measure: Vd/F
time frame: up to 84 days
description: Apparent Volume of Distribution of 610
measure: AE
time frame: up to 84 days
description: To monitor adverse events (AEs) per the NCI CTCAE 5.0.
measure: Immunogenicity
time frame: up to 84 days
description: Percentage of ADA positive and determination of ADA titer as well as Nab
measure: EOS
time frame: up to 84 days
description: Compare the changes of EOS levels with the baseline
arm group label: 610 group
arm group type: Experimental
description: Participants will be administered with 0.03mg/kg, 0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 5.0mg/kg, 7.5mg/kg of 610 by subcutaneous injection. Subjects will be followed for 84 days.
arm group label: controll group
arm group type: Placebo Comparator
description: Participants will be administered with 0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 5.0mg/kg, 7.5mg/kg placebo once by subcutaneous injection. Subjects will be followed for 84 days.
intervention type: Drug
intervention name: 610
description: Recombinant anti-IL-5 Humanized Monoclonal Antibody
arm group label: 610 group
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: controll group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xueying Ding, D.M.
role: Principal Investigator
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
last name: Xin Chou, B.M.
phone: 13701756821
email: 13701756821@163.com
last name: Xueying Ding, D.M.
phone: 13761642319
email: dingxueying@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Pulmonary Eosinophilia
sharing ipd: Undecided