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Melanotan-2

MT-II, Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2

Quick Stats
Studies 3
Trials 100
Completed PHASE2 INTERVENTIONAL NCT03196219

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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).

Interventions

Name: C16G2
Type: DRUG
Description: C16G2
Name: Placebo
Type: DRUG
Description: Varnish Placebo

Primary Outcomes

Measure: Antimicrobial Activity of C16G2
TimeFrame: Evaluated over up to 2 months
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. The antimicrobial activity of crystal violet dye, high sucrose content, sodium tellurite and bacitracin effectively prevent the growth of all bacteria except for streptococci. Further differentiation of streptococci is accomplished by observing colony morphology. S. mutans grows in large blue colonies with dry frosted tops or pale blue gumdrops and can be differentiated from other bacterial colonies.
Measure: Total Oral Bacterial Levels
TimeFrame: 1 day 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.

Trial Information

NCT ID

NCT03196219

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Armata Pharmaceuticals, Inc.

Last Updated

December 15, 2025