<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/NCT04483375</url>
  </required_header>
  <id_info>
    <org_study_id>SCTA01-X101</org_study_id>
    <nct_id>NCT04483375</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of SCTA01, an Anti-SARS-CoV-2 Monoclonal Antibody, in Healthy Chinese Subjects</brief_title>
  <official_title>A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics of SCTA01 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sinocelltech Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sinocelltech 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>
      The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of&#xD;
      SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, First-in-Human, Randomized, Double-blinded, Placebo-Controlled, Single&#xD;
      Ascending Dose Study of SCTA01(Anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese&#xD;
      Subjects.&#xD;
&#xD;
      Dose escalation will be guided by a safety review of clinical signs and symptoms, adverse&#xD;
      events (AEs), and laboratory results of the prior dose cohort.&#xD;
&#xD;
      An Interim analysis will be performed after Day 28 post-dose for the last dose cohort for&#xD;
      review.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2020</start_date>
  <completion_date type="Actual">November 17, 2020</completion_date>
  <primary_completion_date type="Actual">November 17, 2020</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose-limiting toxicity(DLT)</measure>
    <time_frame>7 days</time_frame>
    <description>DLT will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal Tolerable Dose(MTD)</measure>
    <time_frame>12 weeks</time_frame>
    <description>MTD will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-t</measure>
    <time_frame>12 weeks</time_frame>
    <description>Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-t)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞</measure>
    <time_frame>12 weeks</time_frame>
    <description>Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2</measure>
    <time_frame>12 weeks</time_frame>
    <description>Elimination Phase Half-life(t1/2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>12 weeks</time_frame>
    <description>Time to the Maximum Concentration(Tmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-drug antibody(ADA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Positive rate of anti-SCT A01 antibody</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Adverse events as assessed by DAIDS v2.1, including clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Coronavirus Disease 2019(COVID-19)</condition>
  <arm_group>
    <arm_group_label>anti-SARS-CoV-2 monoclonal antibody(SCTA01)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCTA01: single dose on Day0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo: single dose on Day0</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SCTA01</intervention_name>
    <description>recombinant humanized anti-SARS-CoV-2 monoclonal antibody</description>
    <arm_group_label>anti-SARS-CoV-2 monoclonal antibody(SCTA01)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
          -  Males or females. Aged ≥ 18 years old&#xD;
&#xD;
          -  Body mass index (BMI) between 18.0 and 26.0 kg/m2&#xD;
&#xD;
          -  Normal or abnormal but non-clinical significant physical examination, vital signs,&#xD;
             12-ECG and chest CT, etc&#xD;
&#xD;
          -  No plan of pregnancy and being willing to use effective contraceptive measures&#xD;
             (including partner) from informed consent to 6 months after administration of&#xD;
             SCTA01/placebo (abstinence，sterilization operation，contraceptive barrier，acyeterion ,&#xD;
             etc.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a history of severe allergy, such as severe allergic reactions, urticaria,&#xD;
             angioedema;&#xD;
&#xD;
          -  Having one of the following evidence on SARS-CoV-2 infection(previous tests were&#xD;
             accepted)：&#xD;
&#xD;
               -  SARS-CoV-2 positive: reverse transcription-polymerase chain reaction (RT-PCR)&#xD;
                  and/or next generation sequencing (NGS)&#xD;
&#xD;
               -  Previous viral gene sequencing showed high homology with the known SARS-CoV-2&#xD;
&#xD;
               -  Positive specific antibody IgM or IgG against serum SARS-CoV-2&#xD;
&#xD;
          -  Having a history of severe allergies, such as severe allergic reactions, urticaria,&#xD;
             angioedema;&#xD;
&#xD;
          -  Having active infection or fever before to enrollment(≥ 37.3℃)&#xD;
&#xD;
          -  Having primary disease in main organs, such as heart, lung, kidney, liver, nervous&#xD;
             system, gastrointestinal system dysfunction, history of thrombocytopenia or abnormal&#xD;
             bleeding&#xD;
&#xD;
          -  Suffering from autoimmune diseases or a history of autoimmune diseases (such as&#xD;
             systemic lupus erythematosus, thyroid Inflammation, vasculitis, etc.)&#xD;
&#xD;
          -  Within 7 days prior to the first dose of SCTA01/placebo, subject has received any&#xD;
             prescription drugs, non-prescription drugs, Chinese herbal medicines and health&#xD;
             products&#xD;
&#xD;
          -  Within 3 months prior to the first dose of SCTA01/placebo, subjects who participated&#xD;
             in other clinical study, or remaining in the elimination period of the drug (within 5&#xD;
             half-lives) before treatment&#xD;
&#xD;
          -  Within 30 days prior to the first dose of SCTA01/placebo, subjects who have received&#xD;
             vaccine&#xD;
&#xD;
          -  Within 3 months prior to the first dose of SCTA01/placebo, subjects who have received&#xD;
             blood product treatment or blood donation and hemorrhage ≥400mL, or subjects who has a&#xD;
             blood donation plan within 3 months after treatment&#xD;
&#xD;
          -  Within 6 months prior to the first dose of SCTA01/placebo, subjects who have received&#xD;
             major surgery, or has surgery plan during clinical trail&#xD;
&#xD;
          -  Pregnant or lactating women or positive β-HCG, has plan of pregnancy from informed&#xD;
             consent signed to 6 months after administration of SCTA01/placebo&#xD;
&#xD;
          -  Positive of anti-HIV, TP-Ab, anti-HCV, anti-HBV&#xD;
&#xD;
          -  Having a history of epilepsy&#xD;
&#xD;
          -  Having a history of malignancies&#xD;
&#xD;
          -  Within 3 months prior to screening, sujects who have drunk more than 14 standard units&#xD;
             (1 standard unit contains 14g alcohol, such as 360mL beer, 45mL spirits with 40%&#xD;
             alcohol or 150mL wine), or positive of alcohol breath test&#xD;
&#xD;
          -  Within 3 months prior to screening, subjects who smoked more than 5 cigarettes per&#xD;
             day, do not accept smoking cessation during the study&#xD;
&#xD;
          -  Having a history of drug addiction and drug abuse; or who have a positive urine test&#xD;
             result for drug abuse; or cannot guarantee that they will not abuse drugs during the&#xD;
             study&#xD;
&#xD;
          -  Subjects who are not able to follow the plan to complete the study&#xD;
&#xD;
          -  Subjects who are not considered suitable for the study by investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xinghe Wang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Shijitan Hospital, Capital Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing SHIJITAN Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>March 21, 2021</last_update_submitted>
  <last_update_submitted_qc>March 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </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/NCT04483375
org study id: SCTA01-X101
nct id: NCT04483375
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of
      SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.
This is a Phase 1, First-in-Human, Randomized, Double-blinded, Placebo-Controlled, Single
      Ascending Dose Study of SCTA01(Anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese
      Subjects.

      Dose escalation will be guided by a safety review of clinical signs and symptoms, adverse
      events (AEs), and laboratory results of the prior dose cohort.

      An Interim analysis will be performed after Day 28 post-dose for the last dose cohort for
      review.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Dose-limiting toxicity(DLT)
time frame: 7 days
description: DLT will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs
measure: Maximal Tolerable Dose(MTD)
time frame: 12 weeks
description: MTD will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs.
measure: AUC0-t
time frame: 12 weeks
description: Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-t)
measure: AUC0-∞
time frame: 12 weeks
description: Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞)
measure: t1/2
time frame: 12 weeks
description: Elimination Phase Half-life(t1/2)
measure: Tmax
time frame: 12 weeks
description: Time to the Maximum Concentration(Tmax)
measure: Anti-drug antibody(ADA)
time frame: 12 weeks
description: Positive rate of anti-SCT A01 antibody
measure: Adverse events
time frame: 12 weeks
description: Adverse events as assessed by DAIDS v2.1, including clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs
arm group label: anti-SARS-CoV-2 monoclonal antibody(SCTA01)
arm group type: Experimental
description: SCTA01: single dose on Day0
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo: single dose on Day0
intervention type: Biological
intervention name: SCTA01
description: recombinant humanized anti-SARS-CoV-2 monoclonal antibody
arm group label: anti-SARS-CoV-2 monoclonal antibody(SCTA01)
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Xinghe Wang, MD,PhD
role: Principal Investigator
affiliation: Beijing Shijitan Hospital, Capital Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)