<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/NCT03829384</url>
  </required_header>
  <id_info>
    <org_study_id>mRNA-1944-P101</org_study_id>
    <nct_id>NCT03829384</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults</brief_title>
  <official_title>A Phase 1, Randomized, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944, Encoding for an Anti-Chikungunya Virus Monoclonal Antibody, in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ModernaTX, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ModernaTX, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1, FIH, single-center, randomized, placebo controlled, dose escalation study&#xD;
      to evaluate the safety, tolerability, PK, and PD of mRNA-1944 in healthy adult subjects.&#xD;
      Cohorts of mRNA-1944 are planned to be investigated in a sequential dose escalation manner.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Actual">June 7, 2021</completion_date>
  <primary_completion_date type="Actual">June 7, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities</measure>
    <time_frame>Through 13 months of study participation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration versus time curve (AUC)</measure>
    <time_frame>Baseline through 28 days post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed serum concentration (Cmax) after administration of mRNA-1944</measure>
    <time_frame>Baseline through 28 days post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Cmax (tmax)</measure>
    <time_frame>Baseline through 28 days post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination half-life (t1/2)</measure>
    <time_frame>Baseline through 28 days post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed effect (Emax) for chikungunya virus IgG</measure>
    <time_frame>Baseline through 13 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum observed effect for (TEmax) for chikungunya virus IgG</measure>
    <time_frame>Baseline through 13 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the effect curve (AUEC) for chikungunya virus IgG</measure>
    <time_frame>Baseline through 13 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Prevention of Chikungunya Virus Infection</condition>
  <arm_group>
    <arm_group_label>mRNA-1944</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escalating dose levels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>mRNA-1944</intervention_name>
    <description>mRNA encoding Chikungunya antibody</description>
    <arm_group_label>mRNA-1944</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ≥ 18 and ≤ 50 years of age&#xD;
&#xD;
          -  Weight of 50 to 100 kg, inclusive&#xD;
&#xD;
          -  In good general health as determined by medical history, clinical laboratory&#xD;
             assessments, ECG results, vital sign measurements, and physical examination findings&#xD;
             at screening&#xD;
&#xD;
          -  Has access to consistent and reliable means of contact and agrees to stay in contact&#xD;
             with the study site for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any acute or chronic clinically significant disease, as determined by physical&#xD;
             examination or laboratory screening tests&#xD;
&#xD;
          -  Elevated liver function tests or safety laboratory test results&#xD;
&#xD;
          -  Positive screening test for the presence of anti-CHIKV IgG&#xD;
&#xD;
          -  Administration of another investigational study involving any investigational product&#xD;
             within 60 days or 5 half-lives, whichever is longer&#xD;
&#xD;
          -  Has received any live attenuated or inactive vaccines within 4 weeks prior to&#xD;
             check-in, or plans to receive any vaccine during the study&#xD;
&#xD;
          -  Known or suspected immune-mediated disease or immunosuppressive condition (including&#xD;
             lymphoproliferative disorders)&#xD;
&#xD;
          -  Any neurologic disorder&#xD;
&#xD;
          -  History of idiopathic urticaria&#xD;
&#xD;
          -  Any bleeding disorder that is considered a contraindication to study drug infusion or&#xD;
             blood collection&#xD;
&#xD;
          -  Receipt of immunoglobulins, a monoclonal antibody or any blood products within the&#xD;
             preceding 6 months&#xD;
&#xD;
          -  Any acute illness at the time of enrollment&#xD;
&#xD;
          -  A positive test result for drugs of abuse&#xD;
&#xD;
          -  A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or&#xD;
             human immunodeficiency virus type 1 or 2 antibodies&#xD;
&#xD;
          -  A history of active cancer (malignancy) in the last 3 years&#xD;
&#xD;
          -  Donation of ≥ 450 mL blood or blood products within 30 days of study drug infusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>PPD Phase 1 Clinical Research Unit</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>July 5, 2021</last_update_submitted>
  <last_update_submitted_qc>July 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chikungunya fever</keyword>
  <keyword>Alphavirus infections</keyword>
  <keyword>Togavirus</keyword>
  <keyword>Viral diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chikungunya Fever</mesh_term>
  </condition_browse>
  <!-- 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/NCT03829384
org study id: mRNA-1944-P101
nct id: NCT03829384
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1, FIH, single-center, randomized, placebo controlled, dose escalation study
      to evaluate the safety, tolerability, PK, and PD of mRNA-1944 in healthy adult subjects.
      Cohorts of mRNA-1944 are planned to be investigated in a sequential dose escalation manner.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities
time frame: Through 13 months of study participation
measure: Area under the concentration versus time curve (AUC)
time frame: Baseline through 28 days post dose
measure: Maximum observed serum concentration (Cmax) after administration of mRNA-1944
time frame: Baseline through 28 days post dose
measure: Time of Cmax (tmax)
time frame: Baseline through 28 days post dose
measure: Terminal elimination half-life (t1/2)
time frame: Baseline through 28 days post dose
measure: Maximum observed effect (Emax) for chikungunya virus IgG
time frame: Baseline through 13 months
measure: Time to maximum observed effect for (TEmax) for chikungunya virus IgG
time frame: Baseline through 13 months
measure: Area under the effect curve (AUEC) for chikungunya virus IgG
time frame: Baseline through 13 months
arm group label: mRNA-1944
arm group type: Experimental
description: Escalating dose levels
arm group label: Placebo
arm group type: Placebo Comparator
description: Saline
intervention type: Biological
intervention name: mRNA-1944
description: mRNA encoding Chikungunya antibody
arm group label: mRNA-1944
intervention type: Other
intervention name: Placebo
description: Saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chikungunya Fever