<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/NCT03004365</url>
  </required_header>
  <id_info>
    <org_study_id>C3J16-V204-00</org_study_id>
    <nct_id>NCT03004365</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Microbiology of C16G2 Varnish Administered in Multiple Doses to Dental Subjects</brief_title>
  <official_title>A Phase 2, Single-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Microbiology of C16G2 Varnish Administered in Multiple Doses to Adolescent and Adult Dental Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Armata Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Armata Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this single-blind study is to evaluate whether C16G2 Varnish administered in&#xD;
      multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single-blind, randomized, placebo-controlled Phase 2 study to evaluate the safety and oral&#xD;
      microbiology of C16G2 Varnish application in male and female dental subjects 12-75 years of&#xD;
      age. This multi-center study will evaluate multiple study drug administrations of C16G2&#xD;
      Varnish or Placebo Varnish.&#xD;
&#xD;
      The study will enroll subjects into up to three study arms. Up to 33 subjects will receive&#xD;
      multiple doses of study drug applied with a small brush typically used in dental varnish&#xD;
      administration. Subjects will be enrolled in an 8:3 ratio. The Sponsor will perform unblinded&#xD;
      microbiology review on an ongoing basis to determine whether to enroll additional 11 subjects&#xD;
      into the next dose cohort or to terminate enrollment based on microbiology data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2017</start_date>
  <completion_date type="Actual">March 29, 2017</completion_date>
  <primary_completion_date type="Actual">March 29, 2017</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of Multiple C16G2 Varnish Applications</measure>
    <time_frame>Subjects will be followed for safety for 1 week post last study drug administration</time_frame>
    <description>Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events categorized according to system organ class (SOC) and preferred term (PT) based on coding to the Medical Dictionary for Regulatory Activities (MedDRA®), Version 17.1. Comprehensive examinations of oral hard and soft tissue structures, as well as targeted exams of specific musculoskeletal and extraoral sites were performed at selected time points; vital signs (blood pressure, heart rate and temperature) were taken at screening, baseline (Visit 3/Day 0) and Visits 4 and 5.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antimicrobial Activity Against S. Mutans</measure>
    <time_frame>Subjects will be followed for microbiology for 1 month post last study drug administration</time_frame>
    <description>To assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. A summary focusing on mean log transformed S. mutans changes from baseline levels in saliva at each assessment time point following the first administration of C16G2.The log transformed changes from baseline S. mutans levels in saliva at each assessment time point following the first administration of C16G2 in each study arm including N, mean, SD, median and range.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antimicrobial Activity Against Total Bacteria</measure>
    <time_frame>Subjects will be followed for microbiology for 1 month post last study drug administration</time_frame>
    <description>To assess total bacteria in saliva and dental plaque post study drug administration using total bacteria CFUs using Todd Hewitt (TH) agar plating and the log transformed changes from baseline Total Bacteria levels in dental plaque and saliva including N, mean, SD, median and range at each assessment time point following the first administration of C16G2. A summary focusing on mean log transformed S. mutans changes from baseline levels in saliva at each assessment time point following the first administration of C16G2.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Arm 1A: 27.2 mg C16G2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 1B: 27.2 mg Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2A: 13.6 mg C16G2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2B: 13.6 mg Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3A: 54.4 mg C16G2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3B: 54.4 mg Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>C16G2 Varnish</intervention_name>
    <description>Antimicrobial Peptide</description>
    <arm_group_label>Arm 1A: 27.2 mg C16G2</arm_group_label>
    <arm_group_label>Arm 2A: 13.6 mg C16G2</arm_group_label>
    <arm_group_label>Arm 3A: 54.4 mg C16G2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Varnish</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Arm 1B: 27.2 mg Placebo</arm_group_label>
    <arm_group_label>Arm 2B: 13.6 mg Placebo</arm_group_label>
    <arm_group_label>Arm 3B: 54.4 mg Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females, 12-75 years of age&#xD;
&#xD;
          2. Adults subjects provide written informed consent and adolescent subjects give written&#xD;
             or verbal assent, as appropriate, and parent(s) or legal guardian(s) give written&#xD;
             informed consent&#xD;
&#xD;
          3. Female subjects of childbearing potential must agree to use one of the following forms&#xD;
             of contraception from screening through the last study visit: hormonal (oral, implant,&#xD;
             or injection) begun &gt;30 days prior to screening; barrier (condom, diaphragm, or&#xD;
             cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive&#xD;
             options may also include abstinence, relationship with a same sex partner or partner&#xD;
             who has had a vasectomy at least six (6) months prior to the screening visit&#xD;
&#xD;
          4. Negative urine pregnancy test in all females of childbearing potential (past menarche)&#xD;
&#xD;
          5. Male subjects of sexual activity age: willing to use contraception or abstain from&#xD;
             sexual activity beginning with the first exposure to study drug and continuing until&#xD;
             discharged from the study due to completion or Early Termination&#xD;
&#xD;
          6. Healthy, as determined by the Investigator (in consultation with the Medical Monitor,&#xD;
             as needed), based on medical and dental history, concurrent illnesses, laboratory&#xD;
             results, concomitant medications, oral cavity assessment, and targeted physical&#xD;
             examination (general, extraoral, head and neck) during Screening.&#xD;
&#xD;
             Note: Subjects on a stable dose of medication may be eligible for screening and will&#xD;
             be assessed by the medical monitor on a case-by-case basis.&#xD;
&#xD;
          7. Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT&#xD;
             having restorations, crowns or sealants&#xD;
&#xD;
          8. Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes&#xD;
&#xD;
          9. Have a salivary S. mutans of 1.0 x 10^5 CFUs/mL or greater at Screening using mitis&#xD;
             salivarius-bacitracin (MSB) agar plating&#xD;
&#xD;
         10. Willing to refrain from using non-study dentifrice and other non-study oral care&#xD;
             products (oral care rinses, fluoride products, etc.) during the study&#xD;
&#xD;
         11. Willing to postpone elective dental procedures (e.g., dental cleanings) between&#xD;
             Screening and final post-treatment visit (End of Study or Early Termination)&#xD;
&#xD;
         12. Willing and able to comply with oral hygiene and diet instructions&#xD;
&#xD;
         13. Able to communicate with the Investigator/study center personnel, understand and&#xD;
             comply with the study requirements, and willing to return for protocol-specified&#xD;
             visits at the appointed times&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Advanced periodontal disease&#xD;
&#xD;
          2. Active caries lesion(s) within 30 days prior to study drug administration (confirmed&#xD;
             by comprehensive caries examination including standard radiographs). Subjects&#xD;
             presenting with insipient, non-cavitated lesion(s) are not excluded.&#xD;
&#xD;
             Note: If radiographs are deemed appropriate for the study and taken within 6 months&#xD;
             prior to the Screening visit, these may be used for determining eligibility and not&#xD;
             required to be repeated at Screening&#xD;
&#xD;
          3. Partially erupted teeth where the entire crown is not erupted or an operculum is&#xD;
             present&#xD;
&#xD;
          4. Medical condition (e.g., artificial heart valve, history of infective endocarditis,&#xD;
             cardiac transplant with valvular dysfunction, congenital heart disease or total joint&#xD;
             replacement) for which antibiotics are recommended prior to dental visits and/or&#xD;
             procedures&#xD;
&#xD;
          5. Pathologic lesions of the oral cavity (suspicious or confirmed)&#xD;
&#xD;
          6. Full dentures or permanent orthodontic appliances, e.g., braces, buccal or lingual&#xD;
             brackets. Note: Partial dentures, removable retainers and night guards are not&#xD;
             excluded, provided that they are cleaned regularly throughout the duration of the&#xD;
             study&#xD;
&#xD;
          7. Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in&#xD;
             the opinion of the Investigator could influence the study outcome, beginning 30 days&#xD;
             prior to Screening until the end of study participation&#xD;
&#xD;
          8. Medical history indicating the woman is pregnant, breastfeeding/lactating or has a&#xD;
             positive urine pregnancy test&#xD;
&#xD;
          9. Participation in a clinical trial or receipt of a non-FDA approved therapy within 30&#xD;
             days prior to study drug administration (depending on the specifics, participation in&#xD;
             an observational study is not necessarily excluded)&#xD;
&#xD;
         10. Presence of any condition or concurrent illness, which in the opinion of the&#xD;
             Investigator, would compromise normal immune function (e.g., diabetes, rheumatoid&#xD;
             arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of&#xD;
             study dentifrice and oral care products, or interfere with the ability to comply with&#xD;
             study requirements, or jeopardize the safety of the subject or the validity of the&#xD;
             study results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Pittaway, DMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Plaza West II Dental Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John F. Pittaway, DMD</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacqueline Kleven, DDS</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anthony Henegar, DDS, PA</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <results_first_submitted>June 21, 2022</results_first_submitted>
  <results_first_submitted_qc>December 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 29, 2022</results_first_posted>
  <disposition_first_submitted>July 27, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>December 8, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 29, 2022</disposition_first_posted>
  <last_update_submitted>December 8, 2022</last_update_submitted>
  <last_update_submitted_qc>December 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 8, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03004365/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm 1A: 27.2 mg C16G2</title>
          <description>Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
        </group>
        <group group_id="P2">
          <title>Arm 2A: 13.6 mg C16G2</title>
          <description>Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
        </group>
        <group group_id="P3">
          <title>Arm 3A: 54.4 mg C16G2</title>
          <description>Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
        </group>
        <group group_id="P4">
          <title>Group: Pooled Placebo</title>
          <description>Subjects enrolled in Arms 1B (N=3), 2B (N=3) and 3B (N=3) were pooled into one group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm 1A: 27.2 mg C16G2</title>
          <description>Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
        </group>
        <group group_id="B2">
          <title>Arm 2A: 13.6 mg C16G2</title>
          <description>Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
        </group>
        <group group_id="B3">
          <title>Arm 3A: 54.4 mg C16G2</title>
          <description>Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
        </group>
        <group group_id="B4">
          <title>Group: Pooled Placebo</title>
          <description>Subjects enrolled in Arms 1B (N=3), 2B (N=3) and 3B (N=3) were pooled into one group.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="9"/>
            <count group_id="B5" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.7" lower_limit="18" upper_limit="53"/>
                    <measurement group_id="B2" value="28.7" lower_limit="14" upper_limit="52"/>
                    <measurement group_id="B3" value="19.4" lower_limit="17" upper_limit="24"/>
                    <measurement group_id="B4" value="22.2" lower_limit="16" upper_limit="54"/>
                    <measurement group_id="B5" value="24.7" lower_limit="14" upper_limit="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety of Multiple C16G2 Varnish Applications</title>
        <description>Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events categorized according to system organ class (SOC) and preferred term (PT) based on coding to the Medical Dictionary for Regulatory Activities (MedDRA®), Version 17.1. Comprehensive examinations of oral hard and soft tissue structures, as well as targeted exams of specific musculoskeletal and extraoral sites were performed at selected time points; vital signs (blood pressure, heart rate and temperature) were taken at screening, baseline (Visit 3/Day 0) and Visits 4 and 5.</description>
        <time_frame>Subjects will be followed for safety for 1 week post last study drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1A: 27.2 mg C16G2</title>
            <description>Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2A: 13.6 mg C16G2</title>
            <description>Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3A: 54.4 mg C16G2</title>
            <description>Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
          </group>
          <group group_id="O4">
            <title>Group: Pooled Placebo</title>
            <description>Subjects enrolled in Arms 1B (N=3), 2B (N=3) and 3B (N=3) were pooled into one group.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Multiple C16G2 Varnish Applications</title>
          <description>Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events categorized according to system organ class (SOC) and preferred term (PT) based on coding to the Medical Dictionary for Regulatory Activities (MedDRA®), Version 17.1. Comprehensive examinations of oral hard and soft tissue structures, as well as targeted exams of specific musculoskeletal and extraoral sites were performed at selected time points; vital signs (blood pressure, heart rate and temperature) were taken at screening, baseline (Visit 3/Day 0) and Visits 4 and 5.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with Adverse Events Related to Study Drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with Clinical Significant Oral Cavity Changes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with Clinical Significant Vital Sign Changes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with Abnormal Physical Exam Findings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with Completed Study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antimicrobial Activity Against S. Mutans</title>
        <description>To assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. A summary focusing on mean log transformed S. mutans changes from baseline levels in saliva at each assessment time point following the first administration of C16G2.The log transformed changes from baseline S. mutans levels in saliva at each assessment time point following the first administration of C16G2 in each study arm including N, mean, SD, median and range.</description>
        <time_frame>Subjects will be followed for microbiology for 1 month post last study drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1A: 27.2 mg C16G2</title>
            <description>Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2A: 13.6 mg C16G2</title>
            <description>Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3A: 54.4 mg C16G2</title>
            <description>Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
          </group>
          <group group_id="O4">
            <title>Group: Pooled Placebo</title>
            <description>Subjects enrolled in Arms 1B (N=3), 2B (N=3) and 3B (N=3) were pooled into one group.</description>
          </group>
        </group_list>
        <measure>
          <title>Antimicrobial Activity Against S. Mutans</title>
          <description>To assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. A summary focusing on mean log transformed S. mutans changes from baseline levels in saliva at each assessment time point following the first administration of C16G2.The log transformed changes from baseline S. mutans levels in saliva at each assessment time point following the first administration of C16G2 in each study arm including N, mean, SD, median and range.</description>
          <units>log(CFU/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Saliva Sample: S. mutans by MSB Agar Plating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" spread="0.60"/>
                    <measurement group_id="O2" value="-0.08" spread="0.54"/>
                    <measurement group_id="O3" value="-0.015" spread="0.63"/>
                    <measurement group_id="O4" value="-0.09" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dental Plaque: S. mutans by MSB Agar Plating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.51" spread="0.8"/>
                    <measurement group_id="O2" value="-0.28" spread="0.54"/>
                    <measurement group_id="O3" value="-0.58" spread="0.6"/>
                    <measurement group_id="O4" value="-0.59" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antimicrobial Activity Against Total Bacteria</title>
        <description>To assess total bacteria in saliva and dental plaque post study drug administration using total bacteria CFUs using Todd Hewitt (TH) agar plating and the log transformed changes from baseline Total Bacteria levels in dental plaque and saliva including N, mean, SD, median and range at each assessment time point following the first administration of C16G2. A summary focusing on mean log transformed S. mutans changes from baseline levels in saliva at each assessment time point following the first administration of C16G2.</description>
        <time_frame>Subjects will be followed for microbiology for 1 month post last study drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1A: 27.2 mg C16G2</title>
            <description>Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2A: 13.6 mg C16G2</title>
            <description>Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3A: 54.4 mg C16G2</title>
            <description>Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
          </group>
          <group group_id="O4">
            <title>Group: Pooled Placebo</title>
            <description>Subjects enrolled in Arms 1B (N=3), 2B (N=3) and 3B (N=3) were pooled into one group.</description>
          </group>
        </group_list>
        <measure>
          <title>Antimicrobial Activity Against Total Bacteria</title>
          <description>To assess total bacteria in saliva and dental plaque post study drug administration using total bacteria CFUs using Todd Hewitt (TH) agar plating and the log transformed changes from baseline Total Bacteria levels in dental plaque and saliva including N, mean, SD, median and range at each assessment time point following the first administration of C16G2. A summary focusing on mean log transformed S. mutans changes from baseline levels in saliva at each assessment time point following the first administration of C16G2.</description>
          <units>log(CFU/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Saliva Sample - Total Bacteria by TH Agar Plating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="0.49"/>
                    <measurement group_id="O2" value="-0.03" spread="0.22"/>
                    <measurement group_id="O3" value="-0.09" spread="0.55"/>
                    <measurement group_id="O4" value="0.07" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dental Plaque - Total Bacteria by TH Agar Plating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.46" spread="0.69"/>
                    <measurement group_id="O2" value="-0.58" spread="0.3"/>
                    <measurement group_id="O3" value="-0.51" spread="0.57"/>
                    <measurement group_id="O4" value="-0.24" spread="0.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm 1A: 27.2 mg C16G2</title>
          <description>Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
        </group>
        <group group_id="E2">
          <title>Arm 2A: 13.6 mg C16G2</title>
          <description>Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
        </group>
        <group group_id="E3">
          <title>Arm 3A: 54.4 mg C16G2</title>
          <description>Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.</description>
        </group>
        <group group_id="E4">
          <title>Group: Pooled Placebo</title>
          <description>Subjects enrolled in Arms 1B (N=3), 2B (N=3) and 3B (N=3) were pooled into one group.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Operations</name_or_title>
      <organization>Armata Pharmaceuticals, Inc.</organization>
      <phone>3106652928</phone>
      <email>info@armatapharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03004365
org study id: C3J16-V204-00
nct id: NCT03004365
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this single-blind study is to evaluate whether C16G2 Varnish administered in
      multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries.
A single-blind, randomized, placebo-controlled Phase 2 study to evaluate the safety and oral
      microbiology of C16G2 Varnish application in male and female dental subjects 12-75 years of
      age. This multi-center study will evaluate multiple study drug administrations of C16G2
      Varnish or Placebo Varnish.

      The study will enroll subjects into up to three study arms. Up to 33 subjects will receive
      multiple doses of study drug applied with a small brush typically used in dental varnish
      administration. Subjects will be enrolled in an 8:3 ratio. The Sponsor will perform unblinded
      microbiology review on an ongoing basis to determine whether to enroll additional 11 subjects
      into the next dose cohort or to terminate enrollment based on microbiology data.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Safety of Multiple C16G2 Varnish Applications
time frame: Subjects will be followed for safety for 1 week post last study drug administration
description: Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events categorized according to system organ class (SOC) and preferred term (PT) based on coding to the Medical Dictionary for Regulatory Activities (MedDRA®), Version 17.1. Comprehensive examinations of oral hard and soft tissue structures, as well as targeted exams of specific musculoskeletal and extraoral sites were performed at selected time points; vital signs (blood pressure, heart rate and temperature) were taken at screening, baseline (Visit 3/Day 0) and Visits 4 and 5.
measure: Antimicrobial Activity Against S. Mutans
time frame: Subjects will be followed for microbiology for 1 month post last study drug administration
description: To assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. A summary focusing on mean log transformed S. mutans changes from baseline levels in saliva at each assessment time point following the first administration of C16G2.The log transformed changes from baseline S. mutans levels in saliva at each assessment time point following the first administration of C16G2 in each study arm including N, mean, SD, median and range.
measure: Antimicrobial Activity Against Total Bacteria
time frame: Subjects will be followed for microbiology for 1 month post last study drug administration
description: To assess total bacteria in saliva and dental plaque post study drug administration using total bacteria CFUs using Todd Hewitt (TH) agar plating and the log transformed changes from baseline Total Bacteria levels in dental plaque and saliva including N, mean, SD, median and range at each assessment time point following the first administration of C16G2. A summary focusing on mean log transformed S. mutans changes from baseline levels in saliva at each assessment time point following the first administration of C16G2.
arm group label: Arm 1A: 27.2 mg C16G2
arm group type: Active Comparator
description: Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.
arm group label: Arm 1B: 27.2 mg Placebo
arm group type: Placebo Comparator
description: Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.
arm group label: Arm 2A: 13.6 mg C16G2
arm group type: Active Comparator
description: Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.
arm group label: Arm 2B: 13.6 mg Placebo
arm group type: Placebo Comparator
description: Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.
arm group label: Arm 3A: 54.4 mg C16G2
arm group type: Active Comparator
description: Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.
arm group label: Arm 3B: 54.4 mg Placebo
arm group type: Placebo Comparator
description: Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.
intervention type: Drug
intervention name: C16G2 Varnish
description: Antimicrobial Peptide
arm group label: Arm 1A: 27.2 mg C16G2
arm group label: Arm 2A: 13.6 mg C16G2
arm group label: Arm 3A: 54.4 mg C16G2
intervention type: Drug
intervention name: Placebo Varnish
description: Placebo
arm group label: Arm 1B: 27.2 mg Placebo
arm group label: Arm 2B: 13.6 mg Placebo
arm group label: Arm 3B: 54.4 mg Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John Pittaway, DMD
role: Principal Investigator
affiliation: Plaza West II Dental Group
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dental Caries
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 