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Phase 2, Safety & Microbiology Study of C16G2 in Multiple Oral Gel &/or Mouth Rinse Doses to Healthy Adults

Dental Caries Clinical Trial

Official title:
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Microbiology of C16G2 Administered in Multiple Oral Gel and/or Mouth Rinse Doses to Healthy Adult Subjects

Clinical Trial 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.

Clinical Trial Description

The study will evaluate the safety of multiple study drug administrations as assessed by adverse event monitoring, oral cavity assessments, targeted physical exams and vital signs. The study will also assess the study drug's ability to selectively reduce or eliminate specific bacteria in the mouth by comparing a liquid and gel product applied in different modes, such as mouth rinse administration and gel application using a dental tray, electric toothbrush or manual toothbrush administered over 7 consecutive days. Subjects will be followed for approximately 8 days after the last study drug administration for safety and microbiology. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02044081
Study type Interventional
Source Armata Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date February 2014
Completion date August 2014
View Details
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