NCT03052842

A Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Dental Strip Application

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Armata Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Single-blind study to evaluate whether C16G2 Strip 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 oral microbiology and safety of multiple C16G2 Strip applications in male and female dental subjects 12-75 years of age. The study will compare multiple study drug administrations of 9.2 mg, 18.4 mg, and 36.8 mg C16G2 Strip or Placebo in Study Arms 1 through 3, respectively. Enrollment of subjects in Study Arms 1 through 3 will occur sequentially in an ascending dose-escalation manner. Before dosing of study drug, eligible subjects will receive professional dental prophylaxis between Days -7 and -2. Subjects will receive 11 doses administered over approximately two weeks. Each subject will receive a single dose on Day 0, followed by 5 days of AM and PM dosing starting on Day 7. To evaluate the durability of S. mutans suppression, study subjects will be followed for microbiology for up to 1 month after the last study drug administration. Clinic visits include Visit 1 (Screening/Days -30 to -1), Visit 2 (Prophylaxis/Day -7 to -2), Eligibility Confirmation \& Baseline Visit 3, Follow-up Visits 4-7 (Safety and Microbiology), Visits 8-17 (Study Drug Administration), Follow-up Visits 18-20 (Safety and Microbiology) and Follow-up Visits 21-22 (Microbiology only).

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	C16G2 Strip	Antimicrobial Peptide
OTHER	Placebo Strip	Placebo

Timeline

• Start date: 2017-02-09
• Primary completion: 2017-04-05
• Completion: 2017-04-05
• First posted: 2017-02-14
• Last updated: 2022-12-22
• Results posted: 2022-12-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study