NCT02044081

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Armata Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	C16G2 Rinse	Active rinses are 1.6 mg/mL C16G2.
DRUG	Placebo	Placebo is the vehicle without C16G2
DRUG	C16G2 Gel	Active C16G2 Gel is 3.2 mg/mL

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2014-01-23
• Last updated: 2019-08-01

Locations

2 sites across 1 country: United States