Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03196219 | A Phase 2 Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Varnish and Strip in Adolescent and Adult Subjects | PHASE2 | COMPLETED | 20 | — | — | Jul 7, 2017 | Jan 10, 2018 | Dec 22, 2022 | 1 | United States |
| NCT02594254 | Phase 2 Study to Evaluate the Microbiology and Safety of C16G2 Administered to Adult and Adolescent Dental Subjects | PHASE2 | COMPLETED | 135 | — | — | Nov 1, 2015 | Sep 1, 2016 | Aug 1, 2019 | 10 | United States |
| NCT02509845 | Study to Evaluate the Safety and Microbiology of C16G2 in Adolescent and Adult Dental Subjects | PHASE2 | COMPLETED | 64 | — | — | Jul 1, 2015 | Mar 1, 2016 | Aug 1, 2019 | 5 | United States |
| NCT02254993 | Phase 2, Open-Label Study for Safety, Microbiology and PK of Single or Multiple Oral C16G2 Gel Doses | PHASE2 | COMPLETED | 52 | — | — | Oct 1, 2014 | Jul 1, 2015 | Aug 1, 2019 | 2 | United States |
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.
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.
Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events
Subjects will be monitored for adverse events throughout the study. At specified clinic visits a targeted physical exam and oral cavity assessment will be performed and vital signs will be taken.
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
| Arm | Type | Description |
|---|---|---|
| Arm 1: Open-Enrollment Multiple Dose C16G2 Varnish | EXPERIMENTAL | 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. |
| Arm 2A: Single-Blind C16G2 Varnish | EXPERIMENTAL | Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish 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 C16G2 Varnish, 6 subjects Placebo). |
| Arm 2B: Single-Blind Placebo | PLACEBO_COMPARATOR | Twelve subjects will be enrolled in a single-blind manner. Subjects will receive 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 C16G2 Varnish, 6 subjects Placebo). |
| Arm 3: Open-Enrollment Single Dose C16G2 Varnish | EXPERIMENTAL | 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. |
| Study Arm 1 | EXPERIMENTAL | Subjects in Study Arm 1 will receive 4 ml of 800 µM study drug administrations for a total of 28 consecutive days. Subjects will receive 4 C16G2 Gel or placebo administrations at the clinic on the first day, followed by morning (AM) and evening (PM) study drug administrations at the subjects' home for 27 consecutive days. Study drug will be administered via a manual brush. |
| Study Arm 2 | EXPERIMENTAL | Subjects in Study Arm 2 will receive 4 ml of 800 µM study drug administrations for a total of 28 consecutive days. Subjects will receive 4 C16G2 Gel or placebo administrations at the clinic on the first day, followed by morning (AM) and evening (PM) study drug administrations at the subjects' home for 27 consecutive days. Study drug will be administered via a manual brush and custom dental trays. |
| Study Arm 3 | EXPERIMENTAL | Subjects in open-label Study Arm 3 will receive 4 ml of 1600 µM study drug administrations for a total of 7 consecutive days. Subjects will receive 4 C16G2 Gel administrations at the clinic on the first day, followed by morning (AM) and evening (PM) study drug administrations at the clinic for 6 consecutive days. Study drug will be administered via a manual brush and custom dental trays. |
| Study Arm 4 | EXPERIMENTAL | Subjects in open-label Study Arm 4 will receive 4 ml 800 µM C16G2 Gel on a single day. Subjects will receive 4 study drug administrations at the clinic. Study drug will be administered via manual toothbrush and custom dental trays. |
| Study Arm 5 | EXPERIMENTAL | Subjects in open-label Study Arm 4 will receive 4 ml of 1600 µM C16G2 Gel on a single day. Subjects will receive 4 study drug administrations at the clinic. Study drug will be administered via manual toothbrush and custom dental trays. |
| Study Arm 6 | EXPERIMENTAL | If initiated, subjects in Study Arm 6 will receive 4 ml of 1600 µM study drug over a 7 day study drug administration period. Subjects will receive 4 C16G2 Gel or placebo administrations on the first day of dosing followed by morning (AM) and evening (PM) dosing for 6 consecutive days. Study drug will be administered via manual toothbrush and custom dental trays. |
| Study Arm 7 | EXPERIMENTAL | If initiated, subjects in Study Arm 7 will receive 4 ml of 800 µM or 1600 µM study drug on a single day once a week or once a month for a total of 4 days of C16G2 Gel or placebo administration. Subjects will receive 4 study drug administrations on the day of dosing. Study drug will be administered via manual toothbrush and custom dental trays. |
| Adolescent Safety Only Cohort | EXPERIMENTAL | Prior to commencing enrollment of subjects 12-17 years of age in Study Arms 1 \& 2, a safety only cohort of 4 to 8 adolescent subjects will receive 4 administrations of C16G2 on Day 0. |
| Arm 1- Part A | EXPERIMENTAL | One 30-minute C16G2 tray gel application (3.2 mg/mL) over the course of five days |
| Arm 2 - Part A | EXPERIMENTAL | One 4-hour C16G2 tray gel application (3.2 mg/mL) over the course of five days |
| Arm 3- Part A | EXPERIMENTAL | A single 4-hour C16G2 tray gel application (3.2 mg/mL) |
| Arm 4- Part A | EXPERIMENTAL | One 4-hour C16G2 tray gel application (1.6 mg/mL) over the course of five days |
| Arm 5- Part A | EXPERIMENTAL | One 30-minute C16G2 tray gel application (1.6 mg/mL) over the course of five days |
| Arm 6- Part A | EXPERIMENTAL | One 5-minute C16G2 tray gel application (3.2 mg/mL) over the course of five days |
| Arm 1 - Part B | EXPERIMENTAL | 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 2 - Part B | EXPERIMENTAL | 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 3a or 3b or 3c - Part B | EXPERIMENTAL | 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 4a or 4b - Part B | EXPERIMENTAL | 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 5 - Part B | EXPERIMENTAL | Arm 5: Three manual brush gel applications followed by one tray gel application on Day 0, 3.2 mg/mL C16G2 gel concentration. |
| Name | Type | Description |
|---|---|---|
| C16G2 | DRUG | C16G2 |
| Placebo | DRUG | Varnish Placebo |
| C16G2 Gel | DRUG | Antimicrobial peptide |
Inclusion Criteria: 1. Males and females, 12-75 years of age 2. Adults subjects provide written informed consent and adolescent subjects give written or verbal assent, as appropriate, and parent(s) or legal guardian(s) give written informed consent 3. Female subjects of childbearing potential must ...