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C16G2 Rinse · 1 trial · 1 indication
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 (C16G2 subjects in the four study arms vs. placebo).
| Arm | Type | Description |
|---|---|---|
| Mouth Rinse Administration | OTHER | Day 0, three consecutive C16G2 or placebo rinse administrations followed by three single C16G2 or placebo rinse administrations. Days 1 to 6 two additional C16G2 or placebo rinse administrations. |
| Dental Tray Gel Administration | OTHER | Day 0, two C16G2 or placebo gel dental tray applications and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo dental tray applications and two C16G2 or placebo rinse administrations. |
| Electric Toothbrush Gel Application | OTHER | Day 0, four C16G2 or placebo gel administrations applied with an electric toothbrush and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo gel administrations applied with a electric toothbrush and two C16G2 or placebo rinse administrations. |
| Manual Toothbrush Gel Application | OTHER | Day 0, four C16G2 or Placebo gel administrations applied with a manual toothbrush and four C16G2 or Placebo rinse administrations. Days 1 to 6, two C16G2 or Placebo gel administrations applied with a electric toothbrush and two C16G2 or Placebo rinse administrations. |
| Name | Type | Description |
|---|---|---|
| C16G2 Rinse | DRUG | Active rinses are 1.6 mg/mL C16G2. |
| Placebo | DRUG | Placebo is the vehicle without C16G2 |
| C16G2 Gel | DRUG | Active C16G2 Gel is 3.2 mg/mL |
Inclusion Criteria: Subjects are eligible to participate if they meet the following criteria: * Males and females, 18-75 years of age, inclusive, at the time the Informed Consent Form is signed * Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years...
C16G2 Rinse is an investigational small molecule being developed for dental caries, commonly known as tooth decay. It is formulated as a mouth rinse and is intended to target the bacteria that cause cavities. The drug is currently in clinical development and has not been approved by the FDA.
C16G2 Rinse is designed to target and eliminate the specific bacteria responsible for dental caries. While the exact molecular target is not specified, the drug is intended to reduce the microbial load associated with cavity formation. It is being studied for its safety and microbiological effects in healthy adults.
C16G2 Rinse is being developed by Armata Pharmaceuticals, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol ARMP. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for dental caries.
C16G2 Rinse is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, controlled study. The drug is still investigational and has not received FDA approval. Its safety and efficacy are being evaluated in clinical trials.
C16G2 Rinse has been studied in one completed Phase 2 clinical trial, identified as NCT02044081. This trial evaluated the safety and microbiology of C16G2 in multiple oral gel and mouth rinse doses in healthy adults. The study enrolled 60 participants in the United States and was randomized, double-blind, and controlled.
C16G2 Rinse is a formulation of the investigational drug C16G2, specifically designed as a mouth rinse for dental caries. The clinical trial NCT02044081 tested both oral gel and mouth rinse formulations, and the rinse is one of the delivery methods being evaluated. The drug is being developed by Armata Pharmaceuticals.