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/NCT05977101</url>
    </required_header>
    <id_info>
      <org_study_id>2021-121</org_study_id>
      <nct_id>NCT05977101</nct_id>
    </id_info>
    <brief_title>The Safety and Tolerability of MY-586 COVID-19 Neutralizing Antibody Nasal Spray in Healthy Subjects</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-parallel Controlled Clinical Study to Evaluate the Safety and Tolerability of MY-586 SARS-CoV-2 Neutralizing Antibody Nasal Spray in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Second Affiliated Hospital of Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Second Affiliated Hospital of Chongqing Medical University</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 is a randomized, double-blind, placebo-parallel intervention clinical study that will&#xD;
        include approximately 72 healthy subjects based on inclusion and exclusion criteria. Patients&#xD;
        who met the inclusion and exclusion criteria were randomly assigned to one of three different&#xD;
        cohorts. Subjects in each cohort were randomly assigned in a ratio of 5:1 to two parallel&#xD;
        dosing groups, one of which served as the control group. Each cohort was given either an&#xD;
        experimental drug or a placebo nasal spray at different doses and intervals, and blood was&#xD;
        collected on an empty stomach before the first dose, and left nasal swabs and throat swabs&#xD;
        were collected for immunotoxicity and drug concentration testing. 14 days after the last&#xD;
        dose, subjects will return to the study Center for blood samples, left nasal swabs, and&#xD;
        throat swabs to be collected for drug concentration, immunotoxicity, and safety laboratory&#xD;
        indicators (routine blood and biochemistry). To evaluate the safety and tolerability of&#xD;
        MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray in healthy subjects, and to evaluate its&#xD;
        serum concentrations and nasal and pharyngeal swab concentrations by comparing the test&#xD;
        results of different cotillaries.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        As of December 5, 2021, more than 266 million COVID-19 cases and 5.26 million deaths have&#xD;
        been reported worldwide, according to Worldometer Real-time statistics. On 27 November 2021,&#xD;
        a highly mutated new variant of COVID-19 (named Omicron by the WHO) was discovered in South&#xD;
        Africa. Although the introduction of vaccines has played a huge role in the prevention and&#xD;
        control of COVID-19, the neutralizing antibodies stimulated by different vaccines differ&#xD;
        greatly, and the antibody maintains a high titer in the human body for a short time (3-6&#xD;
        months at most), so the global demand for safe and effective prevention of COVID-19 remains&#xD;
        unmet.&#xD;
  &#xD;
        The novel coronavirus neutralizing antibody can directly bind to the envelope of the novel&#xD;
        coronavirus to rapidly block the virus infection, which has been fully verified as a safe and&#xD;
        effective treatment. But so far, there are no approved antibodies at home or abroad to&#xD;
        prevent infection with the novel coronavirus, In addition, there is a lack of broad-spectrum&#xD;
        monoclonal neutralizing antibodies with high efficiency against mutant strains (currently,&#xD;
        all the approved neutralizing antibodies in the world are used in combination with two&#xD;
        antibodies), which can be used as reference for the administration of neutralizing antibodies&#xD;
        for the prevention of a wide range of people (intravenous infusion as the prophylactic&#xD;
        administration will lead to low compliance of the administration population).&#xD;
  &#xD;
        MY-586, a SARS-CoV-2 Neutralizing Antibody, was screened from peripheral blood lymphocytes of&#xD;
        patients recovering from COVID-19, and 209 strains of SARS-CoV-2-specific antibody were&#xD;
        isolated from them, among which MY-586 was a super antibody with strong and effective&#xD;
        neutralizing effect on the novel coronavirus and the circulating strains of UK, India, South&#xD;
        Africa and India Delta.&#xD;
  &#xD;
        Currently, the evaluation of the preclinical efficacy and safety of MY-586 SARS-CoV-2&#xD;
        Neutralizing Antibody and the production of CMC to support clinical trials are nearing&#xD;
        completion. All the data showed that MY-586 SARS-CoV-2 Neutralizing Antibody had excellent&#xD;
        efficacy, safety and druggability. In particular, MY-586 SARS-CoV-2 Neutralizing Antibody is&#xD;
        administered by nasal spray. Although there are no approved nasal spray neutralizing antibody&#xD;
        drugs on the market at home and abroad, the investigators have successfully solved the&#xD;
        drugging of MY-586 SARS-CoV-2 Neutralizing Antibody by nasal spray and the development of&#xD;
        nasal spray device. The nasal spray type MY-586 SARS-CoV-2 Neutralizing Antibody is easy to&#xD;
        carry, easy to administer, and has strong accessibility and compliance for the population. It&#xD;
        can be used as a new and widely used safe and effective preventive measure besides vaccines.&#xD;
        Therefore, the rapid clinical research and development of MY-586 SARS-CoV-2 Neutralizing&#xD;
        Antibody will provide a more effective guarantee for social safety and effective prevention&#xD;
        of COVID-19.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 17, 2021</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <phase>N/A</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>vital signs</measure>
      <time_frame>14 days before the trial,1 days before the trial, after each dose</time_frame>
      <description>Including pulse, blood pressure, temperature</description>
    </primary_outcome>
    <primary_outcome>
      <measure>laboratory tests</measure>
      <time_frame>Including blood routine, blood biochemistry, routine urine pregnancy test (female) limited</time_frame>
      <description>Including blood routine, blood biochemistry, routine urine pregnancy test (female) limited</description>
    </primary_outcome>
    <primary_outcome>
      <measure>12-lead electrocardiogram</measure>
      <time_frame>14 days before the trial,1 days before the trial, after each dose</time_frame>
      <description>Including ECG QT Interval、PR Interval</description>
    </primary_outcome>
    <primary_outcome>
      <measure>adverse events</measure>
      <time_frame>Up to 1 year</time_frame>
      <description>Adverse reactions were recorded by questionnaire. Observe any adverse events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Drug concentration index</measure>
      <time_frame>15 minutes after each dose</time_frame>
      <description>Drug concentration of serum, nasal swab and pharyngeal swab</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunotoxicity detection indicators</measure>
      <time_frame>15 minutes after each dose</time_frame>
      <description>Serum autoantibody titer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cytokines</measure>
      <time_frame>15 minutes after each dose</time_frame>
      <description>Serum Cytokines titer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lymphocyte subsets</measure>
      <time_frame>15 minutes after each dose</time_frame>
      <description>Serum lymphocyte subsets</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>SARS-CoV-2</condition>
    <condition>Prevention</condition>
    <arm_group>
      <arm_group_label>MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Specifications: 5mg/mL, 5mL/ bottle; Provided by Chongqing Mingdao Haoyue Biotechnology Co., LTD</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Specifications: 0mg/mL, 5mL/ bottle; Provided by Chongqing Mingdao Haoyue Biotechnology Co., LTD</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray</intervention_name>
      <description>Patients who met the inclusion and exclusion criteria were randomly assigned to one of three different cohorts. Subjects in each cohort were randomly assigned in a ratio of 5:1 to two parallel dosing groups, one of which served as the control group. Each cohort was given either an experimental drug or a placebo nasal spray at different doses and intervals, and blood was collected on an empty stomach before the first dose, and left nasal swabs and throat swabs were collected for immunotoxicity and drug concentration testing.</description>
      <arm_group_label>MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo Comparator: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient</intervention_name>
      <description>Patients who met the inclusion and exclusion criteria were randomly assigned to one of three different cohorts. Subjects in each cohort were randomly assigned in a ratio of 5:1 to two parallel dosing groups, one of which served as the control group. Each cohort was given either an experimental drug or a placebo nasal spray at different doses and intervals, and blood was collected on an empty stomach before the first dose, and left nasal swabs and throat swabs were collected for immunotoxicity and drug concentration testing.</description>
      <arm_group_label>MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects fully understand the purpose, nature, method and possible adverse reactions&#xD;
               of the experiment, voluntarily participate in the experiment, and sign informed&#xD;
               consent before the experiment begins;&#xD;
  &#xD;
            2. Healthy subjects aged 18-65 years (including the critical value) with an appropriate&#xD;
               sex ratio between men and women;&#xD;
  &#xD;
            3. Body Mass index (BMI) = weight (kg)/height 2 (m2), with a BMI in the range of 19.0 to&#xD;
               30.0 (including the cutoff). Male subjects should weigh at least 50.0kg and female&#xD;
               subjects should weigh at least 45.0kg;&#xD;
  &#xD;
            4. The subjects had no birth plan for 3 months from the date of signing the informed&#xD;
               consent to the end of the study, and agreed to voluntarily take effective and&#xD;
               appropriate contraceptive measures with their partners during this period;&#xD;
  &#xD;
            5. Negative nucleic acid test of novel coronavirus;&#xD;
  &#xD;
            6. Subjects can communicate well with researchers and understand and comply with the&#xD;
               requirements of this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Allergic to any ingredient in this product and auxiliary materials; Or allergic (such&#xD;
               as allergic to two or more drugs, food);&#xD;
  &#xD;
            2. Patients with symptoms of acute upper respiratory tract infection within 1 week before&#xD;
               administration;&#xD;
  &#xD;
            3. Patients with acute episodes of chronic rhinitis or anatomical abnormalities affecting&#xD;
               drug absorption in the nose;&#xD;
  &#xD;
            4. Patients with a history of asthma;&#xD;
  &#xD;
            5. Asplenia or functional asplenia caused by any condition;&#xD;
  &#xD;
            6. Diseases or factors with clinical abnormalities that need to be excluded, including&#xD;
               but not limited to diseases of the nervous system, cardiovascular system, kidney,&#xD;
               liver, gastrointestinal system, respiratory system, metabolism, bone system and other&#xD;
               systems;&#xD;
  &#xD;
            7. Vital signs, physical examination, laboratory examination (such as white blood cell&#xD;
               count less than 3.0*109/L, platelet count less than 75*109/L, TB &gt; 1.5*ULN, ALT &gt;&#xD;
               1*ULN, AST &gt; 1*ULN) and electrocardiogram examination of any items abnormal and judged&#xD;
               by the investigator to be clinically significant;&#xD;
  &#xD;
            8. Use of any prescription or over-the-counter drugs within 14 days before&#xD;
               administration;&#xD;
  &#xD;
            9. Patients who had received immunosuppressive therapy, cytotoxic therapy or inhaled&#xD;
               corticosteroid therapy within 6 months before administration;&#xD;
  &#xD;
           10. A history of drug abuse or use of any drug in the 6 months prior to drug&#xD;
               administration;&#xD;
  &#xD;
           11. Pregnant and lactating women;&#xD;
  &#xD;
           12. The subject has not taken effective and appropriate contraceptive measures within 30&#xD;
               days before the drug administration;&#xD;
  &#xD;
           13. The subjects had sperm and egg donation plans within 3 months after the first drug&#xD;
               administration to the end of the study;&#xD;
  &#xD;
           14. Blood donation or massive blood loss (≥200mL), receiving blood transfusion or using&#xD;
               blood products within 3 months prior to drug administration; Or plan to donate blood&#xD;
               or blood components during the trial;&#xD;
  &#xD;
           15. Have participated in other drug clinical trials or device clinical trials, and have&#xD;
               taken test drugs or used test devices within 3 months before drug administration;&#xD;
  &#xD;
           16. Subjects may not be able to comply with the protocol to complete the study for other&#xD;
               reasons or the investigator may decide that it is not suitable for participants.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dazhi Zhang, M.D.</last_name>
      <role>Study Chair</role>
      <affiliation>The Second Affiliated Hospital of Chongqing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dazhi Zhang, M.D.</last_name>
      <phone>+8613452382818</phone>
      <email>300595@hospital.cqmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Chongqing Medical University</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dazhi Zhang, M.D.</last_name>
        <email>300595@hospital.cqmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>December 2022</verification_date>
    <study_first_submitted>December 27, 2022</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>MY-586 SARS-CoV-2 Neutralizing Antibody</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies</mesh_term>
      <mesh_term>Immunoglobulins</mesh_term>
      <mesh_term>Antibodies, Blocking</mesh_term>
    </intervention_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/NCT05977101
  org study id: 2021-121
  nct id: NCT05977101
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, double-blind, placebo-parallel intervention clinical study that will
        include approximately 72 healthy subjects based on inclusion and exclusion criteria. Patients
        who met the inclusion and exclusion criteria were randomly assigned to one of three different
        cohorts. Subjects in each cohort were randomly assigned in a ratio of 5:1 to two parallel
        dosing groups, one of which served as the control group. Each cohort was given either an
        experimental drug or a placebo nasal spray at different doses and intervals, and blood was
        collected on an empty stomach before the first dose, and left nasal swabs and throat swabs
        were collected for immunotoxicity and drug concentration testing. 14 days after the last
        dose, subjects will return to the study Center for blood samples, left nasal swabs, and
        throat swabs to be collected for drug concentration, immunotoxicity, and safety laboratory
        indicators (routine blood and biochemistry). To evaluate the safety and tolerability of
        MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray in healthy subjects, and to evaluate its
        serum concentrations and nasal and pharyngeal swab concentrations by comparing the test
        results of different cotillaries.
  As of December 5, 2021, more than 266 million COVID-19 cases and 5.26 million deaths have
        been reported worldwide, according to Worldometer Real-time statistics. On 27 November 2021,
        a highly mutated new variant of COVID-19 (named Omicron by the WHO) was discovered in South
        Africa. Although the introduction of vaccines has played a huge role in the prevention and
        control of COVID-19, the neutralizing antibodies stimulated by different vaccines differ
        greatly, and the antibody maintains a high titer in the human body for a short time (3-6
        months at most), so the global demand for safe and effective prevention of COVID-19 remains
        unmet.
  
        The novel coronavirus neutralizing antibody can directly bind to the envelope of the novel
        coronavirus to rapidly block the virus infection, which has been fully verified as a safe and
        effective treatment. But so far, there are no approved antibodies at home or abroad to
        prevent infection with the novel coronavirus, In addition, there is a lack of broad-spectrum
        monoclonal neutralizing antibodies with high efficiency against mutant strains (currently,
        all the approved neutralizing antibodies in the world are used in combination with two
        antibodies), which can be used as reference for the administration of neutralizing antibodies
        for the prevention of a wide range of people (intravenous infusion as the prophylactic
        administration will lead to low compliance of the administration population).
  
        MY-586, a SARS-CoV-2 Neutralizing Antibody, was screened from peripheral blood lymphocytes of
        patients recovering from COVID-19, and 209 strains of SARS-CoV-2-specific antibody were
        isolated from them, among which MY-586 was a super antibody with strong and effective
        neutralizing effect on the novel coronavirus and the circulating strains of UK, India, South
        Africa and India Delta.
  
        Currently, the evaluation of the preclinical efficacy and safety of MY-586 SARS-CoV-2
        Neutralizing Antibody and the production of CMC to support clinical trials are nearing
        completion. All the data showed that MY-586 SARS-CoV-2 Neutralizing Antibody had excellent
        efficacy, safety and druggability. In particular, MY-586 SARS-CoV-2 Neutralizing Antibody is
        administered by nasal spray. Although there are no approved nasal spray neutralizing antibody
        drugs on the market at home and abroad, the investigators have successfully solved the
        drugging of MY-586 SARS-CoV-2 Neutralizing Antibody by nasal spray and the development of
        nasal spray device. The nasal spray type MY-586 SARS-CoV-2 Neutralizing Antibody is easy to
        carry, easy to administer, and has strong accessibility and compliance for the population. It
        can be used as a new and widely used safe and effective preventive measure besides vaccines.
        Therefore, the rapid clinical research and development of MY-586 SARS-CoV-2 Neutralizing
        Antibody will provide a more effective guarantee for social safety and effective prevention
        of COVID-19.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: vital signs
  time frame: 14 days before the trial,1 days before the trial, after each dose
  description: Including pulse, blood pressure, temperature
  measure: laboratory tests
  time frame: Including blood routine, blood biochemistry, routine urine pregnancy test (female) limited
  description: Including blood routine, blood biochemistry, routine urine pregnancy test (female) limited
  measure: 12-lead electrocardiogram
  time frame: 14 days before the trial,1 days before the trial, after each dose
  description: Including ECG QT Interval、PR Interval
  measure: adverse events
  time frame: Up to 1 year
  description: Adverse reactions were recorded by questionnaire. Observe any adverse events
  measure: Drug concentration index
  time frame: 15 minutes after each dose
  description: Drug concentration of serum, nasal swab and pharyngeal swab
  measure: Immunotoxicity detection indicators
  time frame: 15 minutes after each dose
  description: Serum autoantibody titer
  measure: Cytokines
  time frame: 15 minutes after each dose
  description: Serum Cytokines titer
  measure: lymphocyte subsets
  time frame: 15 minutes after each dose
  description: Serum lymphocyte subsets
  arm group label: MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray
  arm group type: Experimental
  description: Specifications: 5mg/mL, 5mL/ bottle; Provided by Chongqing Mingdao Haoyue Biotechnology Co., LTD
  arm group label: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient
  arm group type: Placebo Comparator
  description: Specifications: 0mg/mL, 5mL/ bottle; Provided by Chongqing Mingdao Haoyue Biotechnology Co., LTD
  intervention type: Biological
  intervention name: MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray
  description: Patients who met the inclusion and exclusion criteria were randomly assigned to one of three different cohorts. Subjects in each cohort were randomly assigned in a ratio of 5:1 to two parallel dosing groups, one of which served as the control group. Each cohort was given either an experimental drug or a placebo nasal spray at different doses and intervals, and blood was collected on an empty stomach before the first dose, and left nasal swabs and throat swabs were collected for immunotoxicity and drug concentration testing.
  arm group label: MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray
  intervention type: Other
  intervention name: Placebo Comparator: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient
  description: Patients who met the inclusion and exclusion criteria were randomly assigned to one of three different cohorts. Subjects in each cohort were randomly assigned in a ratio of 5:1 to two parallel dosing groups, one of which served as the control group. Each cohort was given either an experimental drug or a placebo nasal spray at different doses and intervals, and blood was collected on an empty stomach before the first dose, and left nasal swabs and throat swabs were collected for immunotoxicity and drug concentration testing.
  arm group label: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dazhi Zhang, M.D.
  role: Study Chair
  affiliation: The Second Affiliated Hospital of Chongqing Medical University
  last name: Dazhi Zhang, M.D.
  phone: +8613452382818
  email: 300595@hospital.cqmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Antibodies
  mesh term: Immunoglobulins
  mesh term: Antibodies, Blocking
  sharing ipd: No