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C16G2 Strip · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Arm 1A: 9.2 mg C16G2 | EXPERIMENTAL | Study subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. |
| Arm 1B: 9.2 mg Placebo | PLACEBO_COMPARATOR | Study subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. |
| Arm 2A: 18.4 mg C16G2 | EXPERIMENTAL | Study subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. |
| Arm 2B: 18.4 mg Placebo | PLACEBO_COMPARATOR | Study subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. |
| Arm 3A: 36.8 mg C16G2 | EXPERIMENTAL | Study subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). |
| Arm 3B: 36.8 mg Placebo | PLACEBO_COMPARATOR | Study subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). |
| Name | Type | Description |
|---|---|---|
| C16G2 Strip | DRUG | Antimicrobial Peptide |
| Placebo Strip | OTHER | Placebo |
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 ...
C16G2 Strip is an investigational small molecule being developed for dental caries, commonly known as tooth decay. It is designed as a dental strip for application to the teeth. The drug is currently in Phase 2 clinical development and is not yet approved by the FDA.
C16G2 Strip is being developed by Armata Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ARMP. The company is conducting clinical research to evaluate the drug's safety and tolerability in patients with dental caries.
C16G2 Strip is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still undergoing clinical trials to assess its safety and efficacy. The Phase 2 trial for C16G2 Strip has been completed.
C16G2 Strip has one completed Phase 2 clinical trial with the identifier NCT03052842. The study, titled 'A Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Dental Strip Application,' enrolled 30 participants in the United States with dental caries. The trial was placebo-controlled and randomized.
No, C16G2 Strip is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed Phase 2 trial evaluated its safety and tolerability, but the drug has not yet received regulatory approval for marketing or use in patients.