NCT03004365

A Study to Evaluate the Safety and Microbiology of C16G2 Varnish Administered in Multiple Doses to Dental Subjects

A Phase 2, Single-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Microbiology of C16G2 Varnish Administered in Multiple Doses to Adolescent and Adult Dental Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Armata Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this single-blind study is to evaluate whether C16G2 Varnish administered in multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries.

Detailed description

A single-blind, randomized, placebo-controlled Phase 2 study to evaluate the safety and oral microbiology of C16G2 Varnish application in male and female dental subjects 12-75 years of age. This multi-center study will evaluate multiple study drug administrations of C16G2 Varnish or Placebo Varnish. The study will enroll subjects into up to three study arms. Up to 33 subjects will receive multiple doses of study drug applied with a small brush typically used in dental varnish administration. Subjects will be enrolled in an 8:3 ratio. The Sponsor will perform unblinded microbiology review on an ongoing basis to determine whether to enroll additional 11 subjects into the next dose cohort or to terminate enrollment based on microbiology data.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	C16G2 Varnish	Antimicrobial Peptide
DRUG	Placebo Varnish	Placebo

Timeline

• Start date: 2017-01-27
• Primary completion: 2017-03-29
• Completion: 2017-03-29
• First posted: 2016-12-28
• Last updated: 2022-12-29
• Results posted: 2022-12-29

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study