NCT02594254

Phase 2 Study to Evaluate the Microbiology and Safety of C16G2 Administered to Adult and Adolescent Dental Subjects

A Phase 2, Double-Blind, Placebo-Controlled and Open-Label Multi-Center Study to Evaluate the Microbiology and Safety of C16G2 Administered in Multiple Oral Gel Doses to Adult and Adolescent Dental Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Armata Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate if C16G2 Gel administered over a certain period of time either with a toothbrush or a custom dental tray can effectively kill bacteria in the mouth that cause dental cavities.

Detailed description

This multi-center, multiple-arm study will evaluate the microbiological activity and safety of C16G2 Gel in male and female dental subjects, 12 to 75 years of age. The study will be conducted in a randomized, double-blind, placebo-controlled and open-label manner and enroll adolescent (12-17 years of age) and adult subjects (18-75 years of age). A total of approximately 128 study subjects will be enrolled into up to 7 study arms. Study drug (C16G2 Gel or Placebo) will be administered via manual brush gel application (MBGA) or tray gel application (TGA). Two C16G2 concentrations will be evaluated. Four study arms will be conducted in a double blind manner, with a treatment allocation ratio of 4:1 (C16G2:Placebo), three study arms will be conducted in an open-label manner. Before dosing, eligible subjects will undergo professional dental prophylaxis on Day 0. Clinic visits for all study arms will include Visit 1 (Screening/Days -21 to 0), and a varying number of dosing and follow-up visits.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	C16G2 Gel	Antimicrobial peptide
OTHER	Placebo	Placebo

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-06-01
• Completion: 2016-09-01
• First posted: 2015-11-03
• Last updated: 2019-08-01

Locations

10 sites across 1 country: United States