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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 is a Phase 2 study that has completed, run by Armata Pharmaceuticals. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03196219
The ClinicalTrials.gov registry entry for NCT03196219 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Armata Pharmaceuticals, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03196219 reports 0 study locations.
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.
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