NCT03196219

A Phase 2 Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Varnish and Strip in Adolescent and Adult Subjects

A Phase 2, Open-label and Single-Blind Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Varnish and Strip Administered in Multiple Doses to Adolescent and Adult Dental Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Armata Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Accepted

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).

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	C16G2	C16G2
DRUG	Placebo	Varnish Placebo

Timeline

• Start date: 2017-07-07
• Primary completion: 2017-11-22
• Completion: 2018-01-10
• First posted: 2017-06-22
• Last updated: 2022-12-22
• Results posted: 2022-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study