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NCT03196219 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Varnish and Strip in Adolescent and Adult Subjects
A Phase 2 study, sponsored by Armata Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT03196219: Completed Phase 2 study, sponsored by Armata Pharmaceuticals.
NCT03196219 is a Phase 2 study that has completed, run by Armata Pharmaceuticals. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03196219, a Phase 2 study, has completed, sponsored by Armata Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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 bacteri
Interventions
- DRUG Placebo
- DRUG C16G2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-07-07 |
| Est. Completion | 2018-01-10 |
| Phase | Phase 2 |
What the finished NCT03196219 record still lists
NCT03196219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03196219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03196219 about?
NCT03196219 is a clinical study titled "A Phase 2 Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Varnish and Strip in Adolescent and Adult Subjects". 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 Str...
What is the current status of trial NCT03196219?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2017-07-07. Estimated completion is 2018-01-10.
What interventions are being tested in trial NCT03196219?
The interventions under investigation include: Placebo (DRUG), C16G2 (DRUG).
Who is sponsoring clinical trial NCT03196219?
This trial is sponsored by Armata Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03196219's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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