<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/NCT02254993</url>
  </required_header>
  <id_info>
    <org_study_id>C3J14-201B-00</org_study_id>
    <nct_id>NCT02254993</nct_id>
  </id_info>
  <brief_title>Phase 2, Open-Label Study for Safety, Microbiology and PK of Single or Multiple Oral C16G2 Gel Doses</brief_title>
  <official_title>A Phase 2, Open-Label Study to Evaluate the Safety, Microbiology and Pharmacokinetics of C16G2 Administered in Single or Multiple Oral Gel Doses to Healthy Adult 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Part A: Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in&#xD;
      healthy adult male and female subjects 18-75 years of age. All subjects will be assessed for&#xD;
      safety and microbiology parameters. A subset of subjects will be assessed for pharmacokinetic&#xD;
      parameters. No longer enrolling study subjects in Part A.&#xD;
&#xD;
      Part B: Open-label, multiple arm, safety and microbiology study in healthy adult male and&#xD;
      female subjects 18-75 years of age. All subjects will be assessed for safety,&#xD;
      pharmacokinetic, and microbiology parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in healthy&#xD;
      adult male and female subjects 18-75 years of age conducted in two parts.&#xD;
&#xD;
      Part A of the study will evaluate up to 6 study arms, depending on the microbiology response&#xD;
      evaluated. Before dosing of C16G2, eligible subjects will undergo professional dental&#xD;
      prophylaxis on Day 0. Clinic visits for all Study Arms include Visit 1 (Screening/Days -21 to&#xD;
      0), Treatment Visits 2 through 6 (Baseline/Day 0 through Day 4), and follow-up Visits 7&#xD;
      through 11 (Day 5, 8, 12, 19 ± 1 and 33 ± 2).&#xD;
&#xD;
      All subjects will be assessed for safety and microbiology parameters for approximately 5&#xD;
      weeks. A subset of subjects in Study Arms 2 and 4 will be assessed for pharmacokinetic&#xD;
      parameters. Part A of the study is no longer enrolling study subjects.&#xD;
&#xD;
      Part B of the study will evaluate up to 5 study arms, depending on the microbiology response&#xD;
      evaluated during 2 interim microbiology reviews. Clinic visits for all study arms except&#xD;
      Study Arm 5 include Visit 1 (Screening/Days -21 to 0), Visit 2 (Baseline/Day 0), Visits 3&#xD;
      through 17 (Days 1 through 6, morning and evening visits, and Days 7, 10 and 14). All&#xD;
      subjects will be assessed for safety and microbiology parameters for approximately 2 weeks.&#xD;
      Before dosing of C16G2, eligible subjects will undergo professional dental prophylaxis on Day&#xD;
      0. Study drug will be administered for 7 consecutive days. The Sponsor will perform a&#xD;
      microbiology review to evaluate the S. mutans response in Study Arms 1 &amp; 2 and, if&#xD;
      applicable, in Study Arms 3a or 3b. In Study Arm 5, subjects will receive multiple C16G2&#xD;
      doses on a single day and will be evaluated for safety, microbiology and pharmacokinetic&#xD;
      parameters. Clinic visits for Study Arm 5 will include Visit 1 (Screening/Days -21 to 0),&#xD;
      Visit 2 (Baseline/Day 0), Visit 3/Day 1 and Visit 4/Day 6.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the safety of single and multiple C16G2 Gel administrations in healthy adult subjects</measure>
    <time_frame>All subjects will be monitored for safety for approximately 5 weeks (Visit 2 through Visit 11) in Part A, and for 2 weeks (Visit 2 through 17) in Part B of the study</time_frame>
    <description>Safety will be assessed by comparing the incidence and duration of adverse events, clinically significant changes in vital signs, oral cavity assessments and targeted physical exams in the 6 study arms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess antimicrobial activity of C16G2 Gel applications as measured by a reduction in S. mutans in saliva and dental plaque</measure>
    <time_frame>Visit 2 through Visit 11 (Part A) or Visit 17 (Part B)</time_frame>
    <description>All subjects will be assessed for S. mutans levels for approximately 5 weeks (Part A) or 2 weeks (Part B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess total bacteria in saliva and dental plaque post-study drug administration</measure>
    <time_frame>Visit 2 through Visit 11 (Part A only)</time_frame>
    <description>All subjects will be assessed for total bacteria levels for approximately 5 weeks (Part A only)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak plasma concentration (Cmax) after multiple daily C16G2 Gel administrations</measure>
    <time_frame>Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray</time_frame>
    <description>Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to peak plasma concentration (Tmax) after multiple daily C16G2 Gel administrations</measure>
    <time_frame>Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray</time_frame>
    <description>Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve (AUC) after multiple daily C16G2 Gel administrations</measure>
    <time_frame>Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray</time_frame>
    <description>Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution (Vd) after multiple daily C16G2 Gel administrations</measure>
    <time_frame>Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray</time_frame>
    <description>Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination half life (t 1/2) after multiple daily C16G2 Gel administrations</measure>
    <time_frame>Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray</time_frame>
    <description>Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance (Cl) after multiple daily C16G2 Gel administrations</measure>
    <time_frame>Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray</time_frame>
    <description>Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).</description>
  </secondary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Arm 1- Part A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One 30-minute C16G2 tray gel application (3.2 mg/mL) over the course of five days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 - Part A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One 4-hour C16G2 tray gel application (3.2 mg/mL) over the course of five days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3- Part A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single 4-hour C16G2 tray gel application (3.2 mg/mL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4- Part A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One 4-hour C16G2 tray gel application (1.6 mg/mL) over the course of five days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 5- Part A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One 30-minute C16G2 tray gel application (1.6 mg/mL) over the course of five days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 6- Part A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One 5-minute C16G2 tray gel application (3.2 mg/mL) over the course of five days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 1 - Part B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four manual brush gel applications on Day 0 followed by twice daily manual brush gel applications (Days 1 through 6); total of 7-day study drug administration, 3.2 mg/mL C16G2 gel concentration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 - Part B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, 3.2 mg/mL C16G2 gel concentration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3a or 3b or 3c - Part B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Based on the microbiology review, one of 3 study arms will be conducted:&#xD;
Arm 3a: Four manual brush gel applications on Day 0 followed by twice daily manual brush applications (Days 1 through 6); total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL&#xD;
Arm 3b: Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL&#xD;
Arm 3c: Three daily manual brush and/or tray gel applications for 7 days, lower C16G2 concentration of 1.6 mg/mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4a or 4b - Part B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Based on the microbiology review, one of 2 study arms will be conducted:&#xD;
Arm 4a: Four manual brush gel applications on Day 0 followed by twice daily manual brush applications (Days 1 through 6); total of 7-day study drug administration, C16G2 concentration of 1.6 mg/mL and lower gel volume&#xD;
Arm 4b: Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL and lower gel volume</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 5 - Part B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 5: Three manual brush gel applications followed by one tray gel application on Day 0, 3.2 mg/mL C16G2 gel concentration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>C16G2</intervention_name>
    <description>antimicrobial peptide</description>
    <arm_group_label>Arm 1 - Part B</arm_group_label>
    <arm_group_label>Arm 1- Part A</arm_group_label>
    <arm_group_label>Arm 2 - Part A</arm_group_label>
    <arm_group_label>Arm 2 - Part B</arm_group_label>
    <arm_group_label>Arm 3- Part A</arm_group_label>
    <arm_group_label>Arm 3a or 3b or 3c - Part B</arm_group_label>
    <arm_group_label>Arm 4- Part A</arm_group_label>
    <arm_group_label>Arm 4a or 4b - Part B</arm_group_label>
    <arm_group_label>Arm 5 - Part B</arm_group_label>
    <arm_group_label>Arm 5- Part A</arm_group_label>
    <arm_group_label>Arm 6- Part A</arm_group_label>
    <other_name>C16G2 (1.6 mg/mL)</other_name>
    <other_name>C16G2 (3.2 mg/mL)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Parts A &amp; B):&#xD;
&#xD;
          1. Males and females, 18-75 years of age, inclusive, at the time the Informed Consent&#xD;
             Form is signed&#xD;
&#xD;
          2. Female subjects of childbearing potential, defined as not surgically sterile, must&#xD;
             agree to use one of the following forms of contraception from screening through the&#xD;
             last study visit: hormonal (oral, implant, or injection) begun &gt;30 days prior to&#xD;
             screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine&#xD;
             device (IUD). Acceptable contraceptive options may also include abstinence, monogamous&#xD;
             relationship with same sex partner or partner who has had a vasectomy at least six (6)&#xD;
             months prior to the screening visit&#xD;
&#xD;
          3. Male subjects only: willing to use contraception or abstain from sexual activity&#xD;
             beginning with the first exposure to study drug and continuing until discharged from&#xD;
             the study due to completion or Early Termination&#xD;
&#xD;
          4. 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 (extraoral, head and neck) during Screening&#xD;
&#xD;
          5. Have a minimum of six unrestored bicuspids and molars with ≤50% of molars and&#xD;
             bicuspids having restorations, crowns, sealants or are missing&#xD;
&#xD;
          6. Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes&#xD;
&#xD;
          7. Have a salivary S. mutans of 2.0 x 10^4 CFUs/mL or greater (Part A) or 1.0 x 10^5&#xD;
             colony forming unit (CFU)/mL or greater (Part B) at Screening using mitis&#xD;
             salivarius-bacitracin (MSB) agar plating&#xD;
&#xD;
          8. Willing to refrain from using non-study dentifrice and other non-study oral care&#xD;
             products during the study&#xD;
&#xD;
          9. 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;
         10. Able to understand and sign the Informed Consent Form prior to initiation of study&#xD;
             procedures&#xD;
&#xD;
         11. Able to communicate with the Investigator/study site personnel, understand and comply&#xD;
             with the study requirements, and willing to return for protocol-specified visits at&#xD;
             the appointed times&#xD;
&#xD;
        Exclusion Criteria (Parts A &amp; B):&#xD;
&#xD;
          1. Advanced periodontal disease&#xD;
&#xD;
          2. Active caries lesion(s) within 30 days prior to study drug administration (confirmed&#xD;
             by dental examination and standard radiographs)&#xD;
&#xD;
          3. 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;
          4. Pathologic lesions of the oral cavity (suspicious or confirmed)&#xD;
&#xD;
          5. Full or partial dentures, or orthodontic appliances, e.g., night guards, permanent&#xD;
             retainers&#xD;
&#xD;
          6. 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, within 30 days&#xD;
             prior to Screening&#xD;
&#xD;
          7. Medical history indicating the woman is pregnant, breastfeeding/ lactating or she has&#xD;
             a positive urine pregnancy test&#xD;
&#xD;
          8. 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;
          9. Prior participation in a C16G2 clinical trial and known to have received C16G2 active&#xD;
             gel or mouth rinse (Note: placebo subjects are not 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&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam D Marberger, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Center PI</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John F Pittaway, DMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Center PI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Plaza West II Dental Group</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jean Brown Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <disposition_first_submitted>December 15, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>December 16, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 19, 2016</disposition_first_posted>
  <last_update_submitted>July 25, 2019</last_update_submitted>
  <last_update_submitted_qc>July 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2019</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>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02254993
org study id: C3J14-201B-00
nct id: NCT02254993
lead sponsor: 
has dmc: No
Part A: Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in
      healthy adult male and female subjects 18-75 years of age. All subjects will be assessed for
      safety and microbiology parameters. A subset of subjects will be assessed for pharmacokinetic
      parameters. No longer enrolling study subjects in Part A.

      Part B: Open-label, multiple arm, safety and microbiology study in healthy adult male and
      female subjects 18-75 years of age. All subjects will be assessed for safety,
      pharmacokinetic, and microbiology parameters.
Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in healthy
      adult male and female subjects 18-75 years of age conducted in two parts.

      Part A of the study will evaluate up to 6 study arms, depending on the microbiology response
      evaluated. Before dosing of C16G2, eligible subjects will undergo professional dental
      prophylaxis on Day 0. Clinic visits for all Study Arms include Visit 1 (Screening/Days -21 to
      0), Treatment Visits 2 through 6 (Baseline/Day 0 through Day 4), and follow-up Visits 7
      through 11 (Day 5, 8, 12, 19 ± 1 and 33 ± 2).

      All subjects will be assessed for safety and microbiology parameters for approximately 5
      weeks. A subset of subjects in Study Arms 2 and 4 will be assessed for pharmacokinetic
      parameters. Part A of the study is no longer enrolling study subjects.

      Part B of the study will evaluate up to 5 study arms, depending on the microbiology response
      evaluated during 2 interim microbiology reviews. Clinic visits for all study arms except
      Study Arm 5 include Visit 1 (Screening/Days -21 to 0), Visit 2 (Baseline/Day 0), Visits 3
      through 17 (Days 1 through 6, morning and evening visits, and Days 7, 10 and 14). All
      subjects will be assessed for safety and microbiology parameters for approximately 2 weeks.
      Before dosing of C16G2, eligible subjects will undergo professional dental prophylaxis on Day
      0. Study drug will be administered for 7 consecutive days. The Sponsor will perform a
      microbiology review to evaluate the S. mutans response in Study Arms 1 & 2 and, if
      applicable, in Study Arms 3a or 3b. In Study Arm 5, subjects will receive multiple C16G2
      doses on a single day and will be evaluated for safety, microbiology and pharmacokinetic
      parameters. Clinic visits for Study Arm 5 will include Visit 1 (Screening/Days -21 to 0),
      Visit 2 (Baseline/Day 0), Visit 3/Day 1 and Visit 4/Day 6.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: To evaluate the safety of single and multiple C16G2 Gel administrations in healthy adult subjects
time frame: All subjects will be monitored for safety for approximately 5 weeks (Visit 2 through Visit 11) in Part A, and for 2 weeks (Visit 2 through 17) in Part B of the study
description: Safety will be assessed by comparing the incidence and duration of adverse events, clinically significant changes in vital signs, oral cavity assessments and targeted physical exams in the 6 study arms
measure: To assess antimicrobial activity of C16G2 Gel applications as measured by a reduction in S. mutans in saliva and dental plaque
time frame: Visit 2 through Visit 11 (Part A) or Visit 17 (Part B)
description: All subjects will be assessed for S. mutans levels for approximately 5 weeks (Part A) or 2 weeks (Part B)
measure: To assess total bacteria in saliva and dental plaque post-study drug administration
time frame: Visit 2 through Visit 11 (Part A only)
description: All subjects will be assessed for total bacteria levels for approximately 5 weeks (Part A only)
measure: Peak plasma concentration (Cmax) after multiple daily C16G2 Gel administrations
time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
description: Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
measure: Time to peak plasma concentration (Tmax) after multiple daily C16G2 Gel administrations
time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
description: Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
measure: Area under the curve (AUC) after multiple daily C16G2 Gel administrations
time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
description: Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
measure: Volume of distribution (Vd) after multiple daily C16G2 Gel administrations
time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
description: Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
measure: Elimination half life (t 1/2) after multiple daily C16G2 Gel administrations
time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
description: Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
measure: Clearance (Cl) after multiple daily C16G2 Gel administrations
time frame: Subjects will be assessed on a single day. PK time points are pre-study drug, during dosing at 5, 30 min, 2 and 4 hrs in Part A and prior to the 1st and 3rd brush, 5 min post 3rd brush, and 15 min and 1.5 hrs after tray
description: Five study subjects each in Study Arms 2 and 4 (Part A) and six subjects in Study Arm 5 (Part B). Subjects will be assessed on a single day (Visit 6/Day 4 in Part A and Visit 2/Day 0 in Part B).
arm group label: Arm 1- Part A
arm group type: Experimental
description: One 30-minute C16G2 tray gel application (3.2 mg/mL) over the course of five days
arm group label: Arm 2 - Part A
arm group type: Experimental
description: One 4-hour C16G2 tray gel application (3.2 mg/mL) over the course of five days
arm group label: Arm 3- Part A
arm group type: Experimental
description: A single 4-hour C16G2 tray gel application (3.2 mg/mL)
arm group label: Arm 4- Part A
arm group type: Experimental
description: One 4-hour C16G2 tray gel application (1.6 mg/mL) over the course of five days
arm group label: Arm 5- Part A
arm group type: Experimental
description: One 30-minute C16G2 tray gel application (1.6 mg/mL) over the course of five days
arm group label: Arm 6- Part A
arm group type: Experimental
description: One 5-minute C16G2 tray gel application (3.2 mg/mL) over the course of five days
arm group label: Arm 1 - Part B
arm group type: Experimental
description: Four manual brush gel applications on Day 0 followed by twice daily manual brush gel applications (Days 1 through 6); total of 7-day study drug administration, 3.2 mg/mL C16G2 gel concentration.
arm group label: Arm 2 - Part B
arm group type: Experimental
description: Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, 3.2 mg/mL C16G2 gel concentration.
arm group label: Arm 3a or 3b or 3c - Part B
arm group type: Experimental
description: Based on the microbiology review, one of 3 study arms will be conducted:
Arm 3a: Four manual brush gel applications on Day 0 followed by twice daily manual brush applications (Days 1 through 6); total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL
Arm 3b: Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL
Arm 3c: Three daily manual brush and/or tray gel applications for 7 days, lower C16G2 concentration of 1.6 mg/mL
arm group label: Arm 4a or 4b - Part B
arm group type: Experimental
description: Based on the microbiology review, one of 2 study arms will be conducted:
Arm 4a: Four manual brush gel applications on Day 0 followed by twice daily manual brush applications (Days 1 through 6); total of 7-day study drug administration, C16G2 concentration of 1.6 mg/mL and lower gel volume
Arm 4b: Three manual brush gel applications followed by one tray gel application on Day 0. One manual brush application in the morning and one tray gel application in the evening on Days 1 through 6; total of 7-day study drug administration, lower C16G2 concentration of 1.6 mg/mL and lower gel volume
arm group label: Arm 5 - Part B
arm group type: Experimental
description: Arm 5: Three manual brush gel applications followed by one tray gel application on Day 0, 3.2 mg/mL C16G2 gel concentration.
intervention type: Drug
intervention name: C16G2
description: antimicrobial peptide
arm group label: Arm 1 - Part B
arm group label: Arm 1- Part A
arm group label: Arm 2 - Part A
arm group label: Arm 2 - Part B
arm group label: Arm 3- Part A
arm group label: Arm 3a or 3b or 3c - Part B
arm group label: Arm 4- Part A
arm group label: Arm 4a or 4b - Part B
arm group label: Arm 5 - Part B
arm group label: Arm 5- Part A
arm group label: Arm 6- Part A
other name: C16G2 (1.6 mg/mL)
other name: C16G2 (3.2 mg/mL)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adam D Marberger, DDS
role: Principal Investigator
affiliation: Study Center PI
last name: John F Pittaway, DMD
role: Principal Investigator
affiliation: Study Center PI
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dental Caries