A Phase 2 Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Varnish and Strip in Adolescent and Adult Subjects
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      An open-label and single-blind phase 2 study to evaluate the oral microbiology, safety and
      tolerability of multiple C16G2 Varnish and Strip applications in male and female dental
      subjects 12-75 years of age. The study will compare multiple study drug administrations of
      C16G2 Varnish and/or C16G2 Strip in three study arms.

      In Study Arm 1 eight subjects will be enrolled in an open-label manner and will receive a
      daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip
      administered over 7 days. Following the three C16G2 Varnish applications, each subject will
      receive 7 days of AM and PM dosing with C16G2 Strip and will be followed for microbiology for
      up to 2 months after the last study drug administration.

      Study Arm 2 will enroll 12 subjects in a single-blind manner. Subjects will receive four
      C16G2 Varnish or Placebo applications over 7 days, followed by 3 additional weekly varnish
      administrations. Subjects will be followed for microbiology for up to 2 months after the last
      study drug administration.The treatment allocation will be 1:1 (6 subjects receiving C16G2
      Varnish, 6 subjects receiving Placebo).

      Study Arm 3 will be initiated based on the Sponsor's review of all microbiology data up to
      two week post last study drug administration from Study Arm 2. If initiated, Study Arm 3 will
      enroll 6 subjects in an open-label manner. Subjects will receive daily single doses of C16G2
      Varnish over 10 days, for a total of 10 doses and will be followed for microbiology for up to
      2 months after the last study drug administration.
    

Detailed description: 
      An open-label and single-blind phase 2 study to evaluate the oral microbiology, safety and
      tolerability of multiple C16G2 Varnish and Strip applications in male and female dental
      subjects 12-75 years of age.

      The study will compare multiple study drug administrations of 13.6 milligrams (mg) of C16G2
      Varnish and 9.2 mg of C16G2 Strip in three study arms. Before dosing of study drug, eligible
      subjects will receive professional dental prophylaxis between Days -7 and -2.

      In Study Arm 1 eight subjects will be enrolled in an open-label manner and will receive a
      daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip
      administered over 7 days. C16G2 Varnish will be applied with a small brush typically used in
      dental varnish administration. Following the three C16G2 Varnish applications, each subject
      will receive 7 days of AM and PM dosing with C16G2 Strip. To evaluate the durability of S.
      mutans suppression, study subjects will be followed for microbiology for up to 2 months after
      the last study drug administration.

      Study Arm 2 will enroll 12 subjects in a single-blind manner. Subjects will receive four
      C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 & 7), followed by 3
      additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects
      receiving C16G2 Varnish, 6 subjects receiving Placebo). To evaluate the durability of S.
      mutans suppression, study subjects will be followed for microbiology for up to 2 months after
      the last study drug administration.

      Study Arm 3 will be initiated based on the Sponsor's review of all microbiology data up to
      two week post last study drug administration from Study Arm 2.

      If initiated, Study Arm 3 will enroll 6 subjects in an open-label manner. Subjects will
      receive daily single doses of C16G2 Varnish over 10 days, for a total of 10 doses. To
      evaluate the durability of S. mutans suppression, study subjects will be followed for
      microbiology for up to 2 months after the last study drug administration.

      Clinic visits in Study Arm 1 include Visit 1 (Screening/Days -30 to -1), Visit 2
      (Prophylaxis/Day -7 to -2), Eligibility Confirmation, Baseline & First C16G2 Varnish Dosing
      at Visit 3, Visits 4 & 5 (C16G2 Varnish Administration), Visits 6-19 (AM & PM C16G2 Strip
      Administration), Follow-up Visits 20 & 21 (Safety and Microbiology) and Follow-up Visits
      22-24 (Microbiology only).

      Clinic visits in Study Arm 2 include Visit 1 (Screening/Days -30 to -1), Visit 2
      (Prophylaxis/Day -7 to -2), Eligibility Confirmation, Baseline & First C16G2 Varnish or
      Placebo Dosing at Visit 3, Visits 4-9 (C16G2 Varnish or Placebo Administration), Follow-up
      Visits 10 & 11 (Safety and Microbiology) and Follow-up Visits 12-14 (Microbiology only).

      Clinic visits in Study Arm 3 include Clinic Visit 1 (Screening/Days -30 to -1), Visit 2
      (Prophylaxis/Day -7 to -2), Eligibility Confirmation, Baseline & First C16G2 Varnish Dosing
      at Visit 3, Visits 4-12 (C16G2 Varnish Administration), Follow-up Visits 13 & 14 (Safety and
      Microbiology) and Follow-up Visits 15-17 (Microbiology only).
    

Intervention name(s): C16G2; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): C16G2; Varnish Placebo
Other intervention name(s): Antimicrobial Peptide
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Study Arms 1 and 2 will be enrolled in parallel followed by Study Arm 3.
Masking: Single (Participant)
Primary purpose: Treatment