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

NCT02044081 | Completed Phase 2

• 1 other identifier: C3J13-201-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of multiple C16G2 Gel and/or C16G2 Rinse administrations in healthy adult subjects.

  Safety will be assessed by comparing the incidence and duration of adverse events, clinically significant changes in vital signs, oral cavity assessments and targeted physical exams (C16G2 subjects in the four study arms vs. placebo).

  Screening, Baseline, Days 1-7, & Day 14

Secondary Outcomes (2)

• To assess the targeted antimicrobial activity of C16G2 gel and rinse applications as measured by a reduction of dental plaque and salivary Streptococcus mutans (S. mutans).

  Screening, Baseline, Days 1, 7 & 14

• To assess total bacteria in dental plaque and saliva post-study drug. administration

  Screening, Baseline, Days 1, 7 & 14

Study Arms (4)

Mouth Rinse Administration

OTHER

Day 0, three consecutive C16G2 or placebo rinse administrations followed by three single C16G2 or placebo rinse administrations. Days 1 to 6 two additional C16G2 or placebo rinse administrations.

Drug: C16G2 Rinse; Drug: Placebo

Dental Tray Gel Administration

OTHER

Day 0, two C16G2 or placebo gel dental tray applications and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo dental tray applications and two C16G2 or placebo rinse administrations.

Drug: C16G2 Rinse; Drug: Placebo; Drug: C16G2 Gel

Electric Toothbrush Gel Application

OTHER

Day 0, four C16G2 or placebo gel administrations applied with an electric toothbrush and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo gel administrations applied with a electric toothbrush and two C16G2 or placebo rinse administrations.

Drug: C16G2 Rinse; Drug: Placebo; Drug: C16G2 Gel

Manual Toothbrush Gel Application

OTHER

Day 0, four C16G2 or Placebo gel administrations applied with a manual toothbrush and four C16G2 or Placebo rinse administrations. Days 1 to 6, two C16G2 or Placebo gel administrations applied with a electric toothbrush and two C16G2 or Placebo rinse administrations.

Drug: C16G2 Rinse; Drug: Placebo; Drug: C16G2 Gel

Interventions

C16G2 Rinse DRUG

Active rinses are 1.6 mg/mL C16G2.

Dental Tray Gel Administration; Electric Toothbrush Gel Application; Manual Toothbrush Gel Application; Mouth Rinse Administration

Placebo DRUG

Placebo is the vehicle without C16G2

Dental Tray Gel Administration; Electric Toothbrush Gel Application; Manual Toothbrush Gel Application; Mouth Rinse Administration

C16G2 Gel DRUG

Active C16G2 Gel is 3.2 mg/mL

Dental Tray Gel Administration; Electric Toothbrush Gel Application; Manual Toothbrush Gel Application

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are eligible to participate if they meet the following criteria:
• Males and females, 18-75 years of age, inclusive, at the time the Informed Consent Form is signed
• Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years postmenopausal, must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun \>30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, monogamous relationship with same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit.
• Male subjects only: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination.
• Healthy, as determined by the Investigator (in consultation with the Medical Monitor, as needed), based on medical and dental history, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during Screening
• Have a minimum of six unrestored bicuspids and molars with less than 50% of molars and bicuspids having restorations, crowns, sealants or are missing
• Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes
• Demonstrated ability to swish 10 mL of water for 4 minutes
• Have a salivary and dental plaque S. mutans of 2.0 x 10\^4 colony forming unit (CFU)s/mL or greater at Screening using mitis salivarius-bacitracin (MSB) agar plating
• Willing to refrain from using non-study dentifrice and other non-study oral care products during the study
• Willing to postpone elective dental procedures (e.g. dental cleanings) between Screening and final post-treatment visit (End of Study or Early Termination)
• Able to understand and sign the Informed Consent Form prior to initiation of study procedures
• Able to communicate with the Investigator/study site personnel, understand and comply with the study requirements, and willing to return for protocol-specified visits at the appointed times

You may not qualify if:

• Subjects are excluded from participation if any of the following apply:
• Advanced periodontal disease
• Active caries lesion(s) within 30 days prior to study drug administration (confirmed by dental examination and standard radiographs).
• Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
• Pathologic lesions of the oral cavity (suspicious or confirmed)
• Full or partial dentures, or orthodontic appliances, e.g. night guards, permanent retainers
• Impaired salivary function (unable to provide 2 mL of stimulated saliva within 5 minutes)
• Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the Investigator could influence the study outcome, within 30 days prior to Screening
• Medical history indicating the woman is pregnant, breastfeeding/lactating or she has a positive urine pregnancy test
• Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to study drug administration (depending on the specifics, participation in an observational study is not necessarily excluded)
• Presence of any condition or concurrent illness, which in the opinion of the Investigator, would compromise normal immune function (e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements

Sponsors & Collaborators

• Armata Pharmaceuticals, Inc.: lead

Study Sites (2)

Plaza West II Dental Group

Kalispell, Montana, 59901, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Adam Marberger, DDS

  Jean Brown Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 23, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

US (2)