NCT02509845

Study to Evaluate the Safety and Microbiology of C16G2 in Adolescent and Adult Dental Subjects

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Armata Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of the clinical study is to evaluate the safety and bacterial impact of study drug (C16G2) administered in multiple oral gel doses to adolescent and adult dental subjects.

Detailed description

The purpose of the clinical study is to evaluate the safety and microbiology of C16G2 administered in multiple oral gel doses to adolescent and adult dental subjects. Subjects will be assigned to three study cohorts and receive 2 different volumes of C16G2 Gel or Placebo. Prior to commencing enrollment of subjects 12-17 years of age, a safety only cohort of 4-8 adolescent subjects will receive 4 study drug administrations on Day 0. A safety data review will be performed by the Medical Monitor on Days 1 and 5. If no safety concerns are identified, enrollment of adolescent subjects receiving 7 days of study drug administration will be initiated in Study Arms 1 \& 2. Enrollment of adult subjects in Study Arms 1 \& 2 may start before the Adolescent Safety Only Cohort is initiated. Before dosing of study drug, eligible subjects will undergo professional dental prophylaxis on Day 0. Microbiology will be assessed by measuring S. mutans and total bacteria counts.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	C16G2	Antimicrobial peptide
OTHER	Placebo	Placebo

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2015-07-28
• Last updated: 2019-08-01

Locations

5 sites across 1 country: United States