Phase 2, Safety & Microbiology Study of C16G2 in Multiple Oral Gel &/or Mouth Rinse Doses to Healthy Adults
NCT02044081 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2019-08-01
Summary
The focus of the study is to evaluate the safety of multiple study drug administrations and the study drug selectively reducing or eliminating a specific bacteria in the mouth. It will compare a liquid and gel product applied in different modes.
Conditions
- Dental Caries
Interventions
- DRUG
-
C16G2 Rinse
Active rinses are 1.6 mg/mL C16G2.
- DRUG
-
Placebo is the vehicle without C16G2
- DRUG
-
C16G2 Gel
Active C16G2 Gel is 3.2 mg/mL
Sponsors & Collaborators
-
Armata Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Adam Marberger, DDS · Jean Brown Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2014-07-31
- Completion
- 2014-08-31
Countries
- United States
Study Locations
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