<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/NCT04429529</url>
  </required_header>
  <id_info>
    <org_study_id>SCT-001</org_study_id>
    <nct_id>NCT04429529</nct_id>
  </id_info>
  <brief_title>Safety of TY027, a Treatment for COVID-19, in Humans</brief_title>
  <official_title>Phase 1 First-in-Human, Time Lagged, Randomised, Placebo Controlled, Double Blind, Single Ascending Dose Study of TY027 in Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tychan Pte Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tychan Pte Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The emergence and rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019&#xD;
      across 188 countries globally has become a major public health crisis. COVID-19 was declared&#xD;
      a pandemic by the World Health Organisation (WHO) on the 11th March 2020. To date, more than&#xD;
      14,000,000 cases and 600,000 deaths have been reported. COVID-19 is an acute respiratory&#xD;
      disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like&#xD;
      SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through&#xD;
      respiratory droplets or close contact. Fomite transmission has also been implicated as a&#xD;
      transmission route. Common respiratory symptoms such as fever, sore throat, cough and&#xD;
      shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases&#xD;
      progress to severe disease resulting in an estimated 2 - 5% mortality reported. With the&#xD;
      unrelenting increase in cases being reported worldwide, there is thus an urgent need for&#xD;
      therapeutics to be developed and used to disrupt the ongoing pandemic.&#xD;
&#xD;
      To date, there is no specific proven antiviral treatment for COVID-19. Supportive care is&#xD;
      recommended for symptom relief and for severe cases, organ support is critical for optimal&#xD;
      outcome. Numerous vaccine candidates against SARS-CoV-2 are under development and a couple&#xD;
      have entered Phase 1 clinical trials. Remdesivir, a nucleotide analog, developed by Gilead&#xD;
      Sciences as a treatment for Ebola virus disease is currently being repurposed and undergoing&#xD;
      multiple clinical trials to evaluate safety and efficacy in COVID-19 patients. In a&#xD;
      preliminary study, convalescent plasma containing neutralizing antibodies against SARS-CoV-2&#xD;
      has also been experimentally administered in critically ill COVID-19 patients with promising&#xD;
      results. Donor plasma used was rich in virus specific IgG and IgM antibodies as determined by&#xD;
      ELISA. Within days of convalescent plasma treatment, patients showed decrease in viral load&#xD;
      (via qRT-PCR), as well as improved clinical status being observed. Tychan's TY027 will be the&#xD;
      first biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical&#xD;
      trials. It is anticipated that a SARS-COV-2 specific monoclonal antibody therapeutic&#xD;
      administered to acutely infected patients could reduce disease severity as well as prevent&#xD;
      transmission by reducing viral load and viral shedding. It could also be used as prophylaxis&#xD;
      against COVID-19 amongst high risk contacts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1 First-in-Human, Time Lagged, Randomised, Placebo Controlled, Double Blind,&#xD;
      Single Ascending Dose Study of TY027 in Healthy Adult Volunteers.&#xD;
&#xD;
      Safety, tolerability and PK of TY027 will be assessed. The dose escalation will include 32&#xD;
      healthy volunteers across five (5) dose cohorts:&#xD;
&#xD;
        -  0.5 mg/kg, N = 2 TY027 + 2 Placebos&#xD;
&#xD;
        -  5 mg/kg, N = 5 TY027 + 2 Placebos&#xD;
&#xD;
        -  10 mg/kg, N = 5 TY027 + 2 Placebos&#xD;
&#xD;
        -  20 mg/kg, N = 5 TY027 + 2 Placebos&#xD;
&#xD;
        -  30 mg/kg, N = 5 TY027 + 2 Placebos&#xD;
&#xD;
      Subjects will be required to be inpatient at the trial site for approximately 24 hours.&#xD;
&#xD;
      A minimum of 20-hour interval from the first two (2) subjects dosing (1 treatment and 1&#xD;
      placebo concurrently) must take place before the third subject can be dosed within the&#xD;
      cohort. No such time interval will be required for dosing of subsequent subjects (fourth&#xD;
      subject onwards) within the same dose cohort.&#xD;
&#xD;
      After 24 hours, subjects will be discharged from the trial site and to return for scheduled&#xD;
      follow-up visits. Subjects will be followed for up to approximately Day 84 with serum samples&#xD;
      taken at specified times as per outlines in Table 1.&#xD;
&#xD;
      Dose escalations will be guided by a safety review of clinical signs, adverse events (AEs),&#xD;
      laboratory tests (excluding lipase) and immune gene expression data of the prior dose cohort&#xD;
      (up to 72 hours post-dose). Subsequent post-trial monitoring through weekly telephone calls&#xD;
      will continue from Day 85 onwards for another three (3) more months.&#xD;
&#xD;
      Decisions not to dose escalate past any proposed dose level due to safety findings will not&#xD;
      constitute a protocol violation.&#xD;
&#xD;
      Safety summaries (up to Day 3 post-dose) will be generated for each dose cohort and delivered&#xD;
      to the Dose Escalation Review Committee (DERC) for review.&#xD;
&#xD;
      Interim analysis will be performed after Day 14 post-dose for each dose cohort and delivered&#xD;
      to the Data Safety Monitoring Board (DSMB) for review.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Actual">January 20, 2021</completion_date>
  <primary_completion_date type="Actual">November 19, 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>
    <intervention_model_description>Participants are assigned to either treatment or placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>84 Days</time_frame>
    <description>To assess the safety and tolerability of an intravenous (IV) infusion of TY027 when administered to healthy adult volunteers. This will be assessed at various time points by clinical laboratory tests, vital signs and adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Concentration (Cmax) - Pharmacokinetic Assessment</measure>
    <time_frame>84 Days</time_frame>
    <description>Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the maximum concentration (Cmax) of TY027 in human serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment</measure>
    <time_frame>84 Days</time_frame>
    <description>Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the time to maximum concentration (Tmax) of TY027 in human serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment</measure>
    <time_frame>84 Days</time_frame>
    <description>Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the area under the curve extrapolated to infinity (AUC0-∞) of TY027.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment</measure>
    <time_frame>84 Days</time_frame>
    <description>Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the AUC calculated from time of administration to the last measurable concentration (AUC0-last) of TY027.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-Life (t1/2) - Pharmacokinetic Assessment</measure>
    <time_frame>84 Days</time_frame>
    <description>Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the half-life (t1/2) of TY027 in human serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution (Vd) - Pharmacokinetic Assessment</measure>
    <time_frame>84 Days</time_frame>
    <description>Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the volume of distribution (Vd) of TY027 in human serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance [CL] - Pharmacokinetic Assessment</measure>
    <time_frame>84 Days</time_frame>
    <description>Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate clearance [CL] of TY027 in human serum.</description>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Coronavirus Disease-2019 (COVID-19)</condition>
  <arm_group>
    <arm_group_label>TY027 0.5 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will be administered with 0.5 mg/kg of TY027 via IV infusion over a period of 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 0.5 mg/kg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TY027 5mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will be administered with 5 mg/kg of TY027 via IV infusion over a period of 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 5 mg/kg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TY027 10 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will be administered with 10 mg/kg of TY027 via IV infusion over a period of 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 10 mg/kg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TY027 20 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will be administered with 20 mg/kg of TY027 via IV infusion over a period of 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 20 mg/kg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TY027 30 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will be administered with 30 mg/kg of TY027 via IV infusion over a period of 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 30 mg/kg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TY027</intervention_name>
    <description>TY027 Injection, (100 mg/5 mL/Vial), SARS-CoV-2 Monoclonal Antibody (mAb)</description>
    <arm_group_label>TY027 0.5 mg/kg</arm_group_label>
    <arm_group_label>TY027 10 mg/kg</arm_group_label>
    <arm_group_label>TY027 20 mg/kg</arm_group_label>
    <arm_group_label>TY027 30 mg/kg</arm_group_label>
    <arm_group_label>TY027 5mg/kg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>0.9% Saline</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo 0.5 mg/kg</arm_group_label>
    <arm_group_label>Placebo 10 mg/kg</arm_group_label>
    <arm_group_label>Placebo 20 mg/kg</arm_group_label>
    <arm_group_label>Placebo 30 mg/kg</arm_group_label>
    <arm_group_label>Placebo 5 mg/kg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adult volunteers, aged 21 to 50 years old, men or women&#xD;
&#xD;
          2. Subjects negative for human immunodeficiency virus (HIV antibody screen), Hepatitis B&#xD;
             virus surface Antigen (HBsAg) and Hepatitis C virus (HCV antibody screen)&#xD;
&#xD;
          3. Subjects who are willing to comply with the requirements of the study protocol, attend&#xD;
             scheduled visits and make themselves available for the duration of the study with&#xD;
             access to a consistent means of telephone contact, which may be, but not limited to,&#xD;
             at home or at work via landline or mobile&#xD;
&#xD;
          4. Subjects who give written informed consent approved by the Ethical Review Board&#xD;
             governing the site&#xD;
&#xD;
          5. Satisfactory baseline medical assessment as assessed by physical examination and a&#xD;
             stable health status. Normal laboratory values must be within normal range of the&#xD;
             assessing site or show minor variations that are deemed not clinically significant as&#xD;
             judged by the Investigator and acceptable for study entry. A stable health status is&#xD;
             defined as the absence of a health event satisfying the definition of a serious&#xD;
             adverse event&#xD;
&#xD;
          6. Accessible vein in the forearm for blood collection&#xD;
&#xD;
          7. Female subjects of childbearing potential may be enrolled in the study if they have&#xD;
             negative urine pregnancy tests on the day of screening and day of admission&#xD;
&#xD;
          8. Female subjects of non-childbearing potential due to surgical sterilization&#xD;
             (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Post-&#xD;
             menopause subjects must have had at least 12 months of natural (spontaneous)&#xD;
             amenorrhea&#xD;
&#xD;
          9. Both male (if he has a partner of childbearing potential) and female subjects (of&#xD;
             childbearing potential) must agree to use adequate and reliable contraceptive measures&#xD;
             (e.g. spermicides, condoms, contraceptive pills, etc.) or practice abstinence&#xD;
             throughout the duration of the study (up to 84 days post-dosing)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject previously diagnosed with COVID-19 or had been issued with a quarantine order&#xD;
             by the Ministry of Health&#xD;
&#xD;
          2. Presence of acute infection in the preceding 14 days, or presence of a temperature ≥&#xD;
             38.0 ˚C (oral or tympanic temperature assessment), or acute symptoms of any severity&#xD;
             on the scheduled date of admission&#xD;
&#xD;
          3. History of severe drug and / or food allergies and / or known allergies to the trial&#xD;
             product or its components&#xD;
&#xD;
          4. Female subject who is pregnant or breast-feeding&#xD;
&#xD;
          5. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,&#xD;
             neuropsychiatric, or immunosuppressive disorders&#xD;
&#xD;
          6. Evidence of clinically significant anaemia (HB &lt; 10 g/dL) or any other significant&#xD;
             active haematological disease, or having donated &gt; 450 mL of blood within the past&#xD;
             three (3) months&#xD;
&#xD;
          7. Participation or planned participation in a study involving the administration of an&#xD;
             investigational compound within the past four (4) months or during this study period&#xD;
&#xD;
          8. Receipt of immunoglobulins and/or any blood products within nine (9) months of study&#xD;
             enrolment or planned administration of any of these products during the study period&#xD;
&#xD;
          9. Administration of any licensed vaccine within 30 days before the first study vaccine&#xD;
             dose.&#xD;
&#xD;
         10. History of any reaction to monoclonal antibodies&#xD;
&#xD;
         11. Any condition that, in the opinion of the Investigator, would complicate or compromise&#xD;
             the study or well-being of the subject&#xD;
&#xD;
         12. Both male (if he has a partner of childbearing potential) and female subjects (of&#xD;
             childbearing potential) who are unwilling to use adequate contraception or practice&#xD;
             abstinence throughout the duration of the study (up to 84 days post-dosing)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jenny Low, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>SingHealth Investigational Medicine Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SingHealth Investigational Medicine Unit</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus Disease-2019</keyword>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Monoclonal Antibody</keyword>
  <keyword>Infectious diseases</keyword>
  <keyword>Phase 1 first in human study</keyword>
  <keyword>Singapore</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04429529
org study id: SCT-001
nct id: NCT04429529
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The emergence and rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019
      across 188 countries globally has become a major public health crisis. COVID-19 was declared
      a pandemic by the World Health Organisation (WHO) on the 11th March 2020. To date, more than
      14,000,000 cases and 600,000 deaths have been reported. COVID-19 is an acute respiratory
      disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like
      SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through
      respiratory droplets or close contact. Fomite transmission has also been implicated as a
      transmission route. Common respiratory symptoms such as fever, sore throat, cough and
      shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases
      progress to severe disease resulting in an estimated 2 - 5% mortality reported. With the
      unrelenting increase in cases being reported worldwide, there is thus an urgent need for
      therapeutics to be developed and used to disrupt the ongoing pandemic.

      To date, there is no specific proven antiviral treatment for COVID-19. Supportive care is
      recommended for symptom relief and for severe cases, organ support is critical for optimal
      outcome. Numerous vaccine candidates against SARS-CoV-2 are under development and a couple
      have entered Phase 1 clinical trials. Remdesivir, a nucleotide analog, developed by Gilead
      Sciences as a treatment for Ebola virus disease is currently being repurposed and undergoing
      multiple clinical trials to evaluate safety and efficacy in COVID-19 patients. In a
      preliminary study, convalescent plasma containing neutralizing antibodies against SARS-CoV-2
      has also been experimentally administered in critically ill COVID-19 patients with promising
      results. Donor plasma used was rich in virus specific IgG and IgM antibodies as determined by
      ELISA. Within days of convalescent plasma treatment, patients showed decrease in viral load
      (via qRT-PCR), as well as improved clinical status being observed. Tychan's TY027 will be the
      first biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical
      trials. It is anticipated that a SARS-COV-2 specific monoclonal antibody therapeutic
      administered to acutely infected patients could reduce disease severity as well as prevent
      transmission by reducing viral load and viral shedding. It could also be used as prophylaxis
      against COVID-19 amongst high risk contacts.
This is a Phase 1 First-in-Human, Time Lagged, Randomised, Placebo Controlled, Double Blind,
      Single Ascending Dose Study of TY027 in Healthy Adult Volunteers.

      Safety, tolerability and PK of TY027 will be assessed. The dose escalation will include 32
      healthy volunteers across five (5) dose cohorts:

        -  0.5 mg/kg, N = 2 TY027 + 2 Placebos

        -  5 mg/kg, N = 5 TY027 + 2 Placebos

        -  10 mg/kg, N = 5 TY027 + 2 Placebos

        -  20 mg/kg, N = 5 TY027 + 2 Placebos

        -  30 mg/kg, N = 5 TY027 + 2 Placebos

      Subjects will be required to be inpatient at the trial site for approximately 24 hours.

      A minimum of 20-hour interval from the first two (2) subjects dosing (1 treatment and 1
      placebo concurrently) must take place before the third subject can be dosed within the
      cohort. No such time interval will be required for dosing of subsequent subjects (fourth
      subject onwards) within the same dose cohort.

      After 24 hours, subjects will be discharged from the trial site and to return for scheduled
      follow-up visits. Subjects will be followed for up to approximately Day 84 with serum samples
      taken at specified times as per outlines in Table 1.

      Dose escalations will be guided by a safety review of clinical signs, adverse events (AEs),
      laboratory tests (excluding lipase) and immune gene expression data of the prior dose cohort
      (up to 72 hours post-dose). Subsequent post-trial monitoring through weekly telephone calls
      will continue from Day 85 onwards for another three (3) more months.

      Decisions not to dose escalate past any proposed dose level due to safety findings will not
      constitute a protocol violation.

      Safety summaries (up to Day 3 post-dose) will be generated for each dose cohort and delivered
      to the Dose Escalation Review Committee (DERC) for review.

      Interim analysis will be performed after Day 14 post-dose for each dose cohort and delivered
      to the Data Safety Monitoring Board (DSMB) for review.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to either treatment or placebo
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 84 Days
description: To assess the safety and tolerability of an intravenous (IV) infusion of TY027 when administered to healthy adult volunteers. This will be assessed at various time points by clinical laboratory tests, vital signs and adverse events
measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment
time frame: 84 Days
description: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the maximum concentration (Cmax) of TY027 in human serum.
measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment
time frame: 84 Days
description: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the time to maximum concentration (Tmax) of TY027 in human serum
measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment
time frame: 84 Days
description: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the area under the curve extrapolated to infinity (AUC0-∞) of TY027.
measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment
time frame: 84 Days
description: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the AUC calculated from time of administration to the last measurable concentration (AUC0-last) of TY027.
measure: Half-Life (t1/2) - Pharmacokinetic Assessment
time frame: 84 Days
description: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the half-life (t1/2) of TY027 in human serum.
measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment
time frame: 84 Days
description: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the volume of distribution (Vd) of TY027 in human serum.
measure: Clearance [CL] - Pharmacokinetic Assessment
time frame: 84 Days
description: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate clearance [CL] of TY027 in human serum.
arm group label: TY027 0.5 mg/kg
arm group type: Experimental
description: Subject will be administered with 0.5 mg/kg of TY027 via IV infusion over a period of 30 minutes.
arm group label: Placebo 0.5 mg/kg
arm group type: Placebo Comparator
description: Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes.
arm group label: TY027 5mg/kg
arm group type: Experimental
description: Subject will be administered with 5 mg/kg of TY027 via IV infusion over a period of 30 minutes.
arm group label: Placebo 5 mg/kg
arm group type: Placebo Comparator
description: Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes.
arm group label: TY027 10 mg/kg
arm group type: Experimental
description: Subject will be administered with 10 mg/kg of TY027 via IV infusion over a period of 30 minutes.
arm group label: Placebo 10 mg/kg
arm group type: Placebo Comparator
description: Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes.
arm group label: TY027 20 mg/kg
arm group type: Experimental
description: Subject will be administered with 20 mg/kg of TY027 via IV infusion over a period of 30 minutes.
arm group label: Placebo 20 mg/kg
arm group type: Placebo Comparator
description: Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes.
arm group label: TY027 30 mg/kg
arm group type: Experimental
description: Subject will be administered with 30 mg/kg of TY027 via IV infusion over a period of 30 minutes.
arm group label: Placebo 30 mg/kg
arm group type: Placebo Comparator
description: Subject will be administered with 0.9% saline via IV infusion over a period of 30 minutes.
intervention type: Biological
intervention name: TY027
description: TY027 Injection, (100 mg/5 mL/Vial), SARS-CoV-2 Monoclonal Antibody (mAb)
arm group label: TY027 0.5 mg/kg
arm group label: TY027 10 mg/kg
arm group label: TY027 20 mg/kg
arm group label: TY027 30 mg/kg
arm group label: TY027 5mg/kg
intervention type: Other
intervention name: 0.9% Saline
description: Placebo
arm group label: Placebo 0.5 mg/kg
arm group label: Placebo 10 mg/kg
arm group label: Placebo 20 mg/kg
arm group label: Placebo 30 mg/kg
arm group label: Placebo 5 mg/kg
criteria: 
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jenny Low, MBBS
role: Principal Investigator
affiliation: SingHealth Investigational Medicine Unit
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: No