<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/NCT04480957</url>
  </required_header>
  <id_info>
    <org_study_id>ARCT-021-01</org_study_id>
    <nct_id>NCT04480957</nct_id>
  </id_info>
  <brief_title>Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects</brief_title>
  <official_title>A Phase 1/2 Randomised, Double Blinded, Placebo Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Immunogenicity of ARCT-021 in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arcturus Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arcturus Therapeutics, Inc.</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>
      Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in&#xD;
      healthy adult volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized, double blinded (study site staff, subjects and Sponsor), placebo controlled,&#xD;
      adaptive, ascending dose study evaluating administration of ARCT-021 in healthy adult&#xD;
      subjects. 0.9% sterile saline will serve as a placebo control. Study drug (ARCT-021 or&#xD;
      control) will be administered as an intramuscular (IM) injection. The study comprises two&#xD;
      parts. In the Phase 1 part escalating dose levels given as a single injection to younger&#xD;
      adults (21 to 55 years) will be evaluated sequentially. Two dose levels will be further&#xD;
      evaluated in the Phase 2 part of the study in two expansion cohorts in younger adults (21 to&#xD;
      55 years) and in two elderly subject (56 to 80 years) cohorts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Actual">January 29, 2021</completion_date>
  <primary_completion_date type="Actual">January 29, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Incidence, severity and dose-relationship of AEs</measure>
    <time_frame>56 days</time_frame>
    <description>Safety and tolerability of ARCT-021 assessed by determining the incidence, severity and dose-relationship of AEs by dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody</measure>
    <time_frame>Up to 56 days</time_frame>
    <description>SARS-CoV-2-specific serum neutralizing antibody levels, expressed as GMT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean titre for SARS-CoV-2-specific serum neutralizing antibody levels</measure>
    <time_frame>Up to 56 days</time_frame>
    <description>SARS-CoV-2-specific serum neutralizing antibody levels, expressed as mean titer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean fold rise in titre for SARS-CoV-2-spike protein specific neutralizing antibody levels</measure>
    <time_frame>Up to 56 days</time_frame>
    <description>GMFR in titre for SARS-CoV-2-spike protein specific neutralizing antibodies from before vaccination to each subsequent time point</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Increase in SARS-CoV-2--spike protein-specific binding antibody levels</measure>
    <time_frame>Up to 56 days</time_frame>
    <description>GMFR in SARS-CoV-2--spike protein-specific binding antibody levels from before vaccination to each subsequent time point</description>
  </other_outcome>
  <other_outcome>
    <measure>Geometric mean SARS-CoV-2--spike protein-specific binding antibody titre</measure>
    <time_frame>Up to 56 days</time_frame>
    <description>GMT for SARS-CoV-2--spike protein-specific binding antibody levels</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean SARS-CoV-2--spike protein-specific binding antibody titre</measure>
    <time_frame>Up to 56 days</time_frame>
    <description>Mean titer for SARS-CoV-2--spike protein-specific binding antibody levels</description>
  </other_outcome>
  <other_outcome>
    <measure>SARS-CoV-2-specific serum neutralizing antibody seroconversion rate</measure>
    <time_frame>56 days</time_frame>
    <description>Proportion of participants that are seronegative before vaccination achieving a titer of greater than or equal to 20 for SARS-CoV-2-specific serum neutralizing antibodies</description>
  </other_outcome>
  <other_outcome>
    <measure>SARS-CoV-2-specific serum neutralizing antibody seroconversion rate (seropositive baseline)</measure>
    <time_frame>56 days</time_frame>
    <description>Proportion of participants that are seropositive before vaccination achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralizing antibody levels</description>
  </other_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>Escalation Cohort dose 1 of ARCT-021, 21 - 55 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escalation Cohort dose 1 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Escalation Cohort dose 2 of ARCT-021, 21 -55 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escalation Cohort dose 2 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Escalation Cohort dose 3 of ARCT-021, 21 - 55 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escalation Cohort dose 3 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Escalation Cohort dose 4 of ARCT-021, 21 - 55 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escalation Cohort dose 4 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion cohort dose regimen 1, 21 - 55 years.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion cohort dose regimen 2, 21 - 55 years.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion cohort dose regimen 1, 56 - 80 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion cohort dose regimen 2, 56 - 80 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ARCT-021 Dose 1</intervention_name>
    <description>ARCT-021 Dose 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP)</description>
    <arm_group_label>Escalation Cohort dose 1 of ARCT-021, 21 - 55 years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ARCT-021 Dose 2</intervention_name>
    <description>ARCT-021 Dose 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021</description>
    <arm_group_label>Escalation Cohort dose 2 of ARCT-021, 21 -55 years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ARCT-021 Dose 3</intervention_name>
    <description>ARCT-021 Dose 3 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021</description>
    <arm_group_label>Escalation Cohort dose 3 of ARCT-021, 21 - 55 years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ARCT-021 Dose 4</intervention_name>
    <description>ARCT-021 Dose 4 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021</description>
    <arm_group_label>Escalation Cohort dose 4 of ARCT-021, 21 - 55 years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ARCT-021 Dose Regimen 1</intervention_name>
    <description>ARCT-021 dose regimen 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021</description>
    <arm_group_label>Expansion cohort dose regimen 1, 21 - 55 years.</arm_group_label>
    <arm_group_label>Expansion cohort dose regimen 1, 56 - 80 years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ARCT-021 Dose Regimen 2</intervention_name>
    <description>ARCT-021 dose regimen 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021</description>
    <arm_group_label>Expansion cohort dose regimen 2, 21 - 55 years.</arm_group_label>
    <arm_group_label>Expansion cohort dose regimen 2, 56 - 80 years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sterile 0.9% saline</description>
    <arm_group_label>Escalation Cohort dose 1 of ARCT-021, 21 - 55 years</arm_group_label>
    <arm_group_label>Escalation Cohort dose 2 of ARCT-021, 21 -55 years</arm_group_label>
    <arm_group_label>Escalation Cohort dose 3 of ARCT-021, 21 - 55 years</arm_group_label>
    <arm_group_label>Escalation Cohort dose 4 of ARCT-021, 21 - 55 years</arm_group_label>
    <arm_group_label>Expansion cohort dose regimen 1, 21 - 55 years.</arm_group_label>
    <arm_group_label>Expansion cohort dose regimen 1, 56 - 80 years</arm_group_label>
    <arm_group_label>Expansion cohort dose regimen 2, 21 - 55 years.</arm_group_label>
    <arm_group_label>Expansion cohort dose regimen 2, 56 - 80 years</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males or females aged 21 to 80 at the time of informed consent.&#xD;
&#xD;
          2. Body Mass Index 18-35 kg/m2, inclusive, at screening&#xD;
&#xD;
          3. Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight&#xD;
             training, intense aerobics classes etc.) and alcohol for at least 72 hours prior to&#xD;
             study visits&#xD;
&#xD;
          4. Temperature is less than 99.3 degrees Fahrenheit (37.4 degrees Celsius) at screening&#xD;
             AND at the pre-dose evaluation on Day 1&#xD;
&#xD;
          5. Willing and able to comply with protocol-defined procedures and complete all study&#xD;
             visits&#xD;
&#xD;
          6. Males must be surgically sterile or willing to use adequate contraception; females&#xD;
             must be post-menopausal, surgically sterile or willing to use adequate contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or breast feeding&#xD;
&#xD;
          2. Clinically significant abnormalities in medical history&#xD;
&#xD;
          3. Out of range screening laboratory results&#xD;
&#xD;
          4. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C&#xD;
             or chronic hepatitis B&#xD;
&#xD;
          5. Uncontrolled hypertension (BP &gt; 160/100 mm Hg)&#xD;
&#xD;
          6. Uncontrolled diabetes&#xD;
&#xD;
          7. Any history of autoimmune disease&#xD;
&#xD;
          8. Immunodeficiency of any cause&#xD;
&#xD;
          9. History of Chronic liver disease&#xD;
&#xD;
         10. Treatment with another investigational drug, biological agent, or device within one&#xD;
             month of screening, or 5 half-lives of investigational drug, whichever is longer&#xD;
&#xD;
         11. Recent (within 1 year) history of, or current drug or alcohol abuse&#xD;
&#xD;
         12. Has any blood dyscrasias or significant disorder of coagulation&#xD;
&#xD;
         13. Has an acute illness, as determined by the investigator, with or without fever&#xD;
             [temperature &gt;38.0 degrees Celsius (100.4 degrees Fahrenheit)] within 72 hours prior&#xD;
             to each vaccination&#xD;
&#xD;
         14. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or&#xD;
             carcinoma in situ of the cervix that has been successfully treated.&#xD;
&#xD;
         15. Received or plans to receive another vaccine within 4 weeks before study vaccination&#xD;
             or at any time during the study.&#xD;
&#xD;
         16. Receipt of any other SARS CoV-2 or other experimental coronavirus vaccine at any time&#xD;
             prior to study or planned during the study&#xD;
&#xD;
         17. Have any other conditions, which, in the opinion of the Investigator or Sponsor would&#xD;
             make the subject unsuitable for inclusion, or could interfere with the subject&#xD;
             participating in or completing the Study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jenny Low Guek Hong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SingHealth Investigational Medicine Unit (IMU)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>August 12, 2021</last_update_submitted>
  <last_update_submitted_qc>August 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04480957
org study id: ARCT-021-01
nct id: NCT04480957
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in
      healthy adult volunteers.
Randomized, double blinded (study site staff, subjects and Sponsor), placebo controlled,
      adaptive, ascending dose study evaluating administration of ARCT-021 in healthy adult
      subjects. 0.9% sterile saline will serve as a placebo control. Study drug (ARCT-021 or
      control) will be administered as an intramuscular (IM) injection. The study comprises two
      parts. In the Phase 1 part escalating dose levels given as a single injection to younger
      adults (21 to 55 years) will be evaluated sequentially. Two dose levels will be further
      evaluated in the Phase 2 part of the study in two expansion cohorts in younger adults (21 to
      55 years) and in two elderly subject (56 to 80 years) cohorts.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Incidence, severity and dose-relationship of AEs
time frame: 56 days
description: Safety and tolerability of ARCT-021 assessed by determining the incidence, severity and dose-relationship of AEs by dose
measure: Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody
time frame: Up to 56 days
description: SARS-CoV-2-specific serum neutralizing antibody levels, expressed as GMT
measure: Mean titre for SARS-CoV-2-specific serum neutralizing antibody levels
time frame: Up to 56 days
description: SARS-CoV-2-specific serum neutralizing antibody levels, expressed as mean titer
measure: Geometric mean fold rise in titre for SARS-CoV-2-spike protein specific neutralizing antibody levels
time frame: Up to 56 days
description: GMFR in titre for SARS-CoV-2-spike protein specific neutralizing antibodies from before vaccination to each subsequent time point
measure: Increase in SARS-CoV-2--spike protein-specific binding antibody levels
time frame: Up to 56 days
description: GMFR in SARS-CoV-2--spike protein-specific binding antibody levels from before vaccination to each subsequent time point
measure: Geometric mean SARS-CoV-2--spike protein-specific binding antibody titre
time frame: Up to 56 days
description: GMT for SARS-CoV-2--spike protein-specific binding antibody levels
measure: Mean SARS-CoV-2--spike protein-specific binding antibody titre
time frame: Up to 56 days
description: Mean titer for SARS-CoV-2--spike protein-specific binding antibody levels
measure: SARS-CoV-2-specific serum neutralizing antibody seroconversion rate
time frame: 56 days
description: Proportion of participants that are seronegative before vaccination achieving a titer of greater than or equal to 20 for SARS-CoV-2-specific serum neutralizing antibodies
measure: SARS-CoV-2-specific serum neutralizing antibody seroconversion rate (seropositive baseline)
time frame: 56 days
description: Proportion of participants that are seropositive before vaccination achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralizing antibody levels
arm group label: Escalation Cohort dose 1 of ARCT-021, 21 - 55 years
arm group type: Experimental
description: Escalation Cohort dose 1 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
arm group label: Escalation Cohort dose 2 of ARCT-021, 21 -55 years
arm group type: Experimental
description: Escalation Cohort dose 2 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
arm group label: Escalation Cohort dose 3 of ARCT-021, 21 - 55 years
arm group type: Experimental
description: Escalation Cohort dose 3 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
arm group label: Escalation Cohort dose 4 of ARCT-021, 21 - 55 years
arm group type: Experimental
description: Escalation Cohort dose 4 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
arm group label: Expansion cohort dose regimen 1, 21 - 55 years.
arm group type: Experimental
description: Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.
arm group label: Expansion cohort dose regimen 2, 21 - 55 years.
arm group type: Experimental
description: Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.
arm group label: Expansion cohort dose regimen 1, 56 - 80 years
arm group type: Experimental
description: Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.
arm group label: Expansion cohort dose regimen 2, 56 - 80 years
arm group type: Experimental
description: Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.
intervention type: Biological
intervention name: ARCT-021 Dose 1
description: ARCT-021 Dose 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP)
arm group label: Escalation Cohort dose 1 of ARCT-021, 21 - 55 years
intervention type: Biological
intervention name: ARCT-021 Dose 2
description: ARCT-021 Dose 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
arm group label: Escalation Cohort dose 2 of ARCT-021, 21 -55 years
intervention type: Biological
intervention name: ARCT-021 Dose 3
description: ARCT-021 Dose 3 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
arm group label: Escalation Cohort dose 3 of ARCT-021, 21 - 55 years
intervention type: Biological
intervention name: ARCT-021 Dose 4
description: ARCT-021 Dose 4 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
arm group label: Escalation Cohort dose 4 of ARCT-021, 21 - 55 years
intervention type: Biological
intervention name: ARCT-021 Dose Regimen 1
description: ARCT-021 dose regimen 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
arm group label: Expansion cohort dose regimen 1, 21 - 55 years.
arm group label: Expansion cohort dose regimen 1, 56 - 80 years
intervention type: Biological
intervention name: ARCT-021 Dose Regimen 2
description: ARCT-021 dose regimen 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
arm group label: Expansion cohort dose regimen 2, 21 - 55 years.
arm group label: Expansion cohort dose regimen 2, 56 - 80 years
intervention type: Other
intervention name: Placebo
description: Sterile 0.9% saline
arm group label: Escalation Cohort dose 1 of ARCT-021, 21 - 55 years
arm group label: Escalation Cohort dose 2 of ARCT-021, 21 -55 years
arm group label: Escalation Cohort dose 3 of ARCT-021, 21 - 55 years
arm group label: Escalation Cohort dose 4 of ARCT-021, 21 - 55 years
arm group label: Expansion cohort dose regimen 1, 21 - 55 years.
arm group label: Expansion cohort dose regimen 1, 56 - 80 years
arm group label: Expansion cohort dose regimen 2, 21 - 55 years.
arm group label: Expansion cohort dose regimen 2, 56 - 80 years
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jenny Low Guek Hong, MD
role: Principal Investigator
affiliation: SingHealth Investigational Medicine Unit (IMU)
facility: 
country: Singapore
responsible party type: Sponsor