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

NCT03004365 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C3J16-V204-00
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Safety of Multiple C16G2 Varnish Applications

  Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events categorized according to system organ class (SOC) and preferred term (PT) based on coding to the Medical Dictionary for Regulatory Activities (MedDRA®), Version 17.1. Comprehensive examinations of oral hard and soft tissue structures, as well as targeted exams of specific musculoskeletal and extraoral sites were performed at selected time points; vital signs (blood pressure, heart rate and temperature) were taken at screening, baseline (Visit 3/Day 0) and Visits 4 and 5.

  Subjects will be followed for safety for 1 week post last study drug administration

Secondary Outcomes (2)

• Antimicrobial Activity Against S. Mutans

  Subjects will be followed for microbiology for 1 month post last study drug administration

• Antimicrobial Activity Against Total Bacteria

  Subjects will be followed for microbiology for 1 month post last study drug administration

Study Arms (6)

Arm 1A: 27.2 mg C16G2

ACTIVE COMPARATOR

Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.

Drug: C16G2 Varnish

Arm 1B: 27.2 mg Placebo

PLACEBO COMPARATOR

Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.

Drug: Placebo Varnish

Arm 2A: 13.6 mg C16G2

ACTIVE COMPARATOR

Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.

Drug: C16G2 Varnish

Arm 2B: 13.6 mg Placebo

PLACEBO COMPARATOR

Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.

Drug: Placebo Varnish

Arm 3A: 54.4 mg C16G2

ACTIVE COMPARATOR

Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.

Drug: C16G2 Varnish

Arm 3B: 54.4 mg Placebo

PLACEBO COMPARATOR

Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications.

Drug: Placebo Varnish

Interventions

C16G2 Varnish DRUG

Antimicrobial Peptide

Arm 1A: 27.2 mg C16G2; Arm 2A: 13.6 mg C16G2; Arm 3A: 54.4 mg C16G2

Placebo Varnish DRUG

Placebo

Arm 1B: 27.2 mg Placebo; Arm 2B: 13.6 mg Placebo; Arm 3B: 54.4 mg Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, 12-75 years of age
• Adults subjects provide written informed consent and adolescent subjects give written or verbal assent, as appropriate, and parent(s) or legal guardian(s) give written informed consent
• Female subjects of childbearing potential 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, relationship with a same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit
• Negative urine pregnancy test in all females of childbearing potential (past menarche)
• Male subjects of sexual activity age: 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, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (general, extraoral, head and neck) during Screening.
• Note: Subjects on a stable dose of medication may be eligible for screening and will be assessed by the medical monitor on a case-by-case basis.
• Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT having restorations, crowns or sealants
• Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes
• Have a salivary S. mutans of 1.0 x 10\^5 CFUs/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 (oral care rinses, fluoride products, etc.) 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)
• Willing and able to comply with oral hygiene and diet instructions
• Able to communicate with the Investigator/study center 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:

• Advanced periodontal disease
• Active caries lesion(s) within 30 days prior to study drug administration (confirmed by comprehensive caries examination including standard radiographs). Subjects presenting with insipient, non-cavitated lesion(s) are not excluded.
• Note: If radiographs are deemed appropriate for the study and taken within 6 months prior to the Screening visit, these may be used for determining eligibility and not required to be repeated at Screening
• Partially erupted teeth where the entire crown is not erupted or an operculum is present
• 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 dentures or permanent orthodontic appliances, e.g., braces, buccal or lingual brackets. Note: Partial dentures, removable retainers and night guards are not excluded, provided that they are cleaned regularly throughout the duration of the study
• Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the Investigator could influence the study outcome, beginning 30 days prior to Screening until the end of study participation
• Medical history indicating the woman is pregnant, breastfeeding/lactating or 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, or jeopardize the safety of the subject or the validity of the study results

Sponsors & Collaborators

• Armata Pharmaceuticals, Inc.: lead

Study Sites (3)

John F. Pittaway, DMD

Kalispell, Montana, 59901, United States

Location

Jacqueline Kleven, DDS

Bedford, Texas, 76021, United States

Location

Anthony Henegar, DDS, PA

Irving, Texas, 75063, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Clinical Operations
• Organization: Armata Pharmaceuticals, Inc.

info@armatapharma.com

3106652928

Study Officials

• John Pittaway, DMD

  Plaza West II Dental Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 28, 2016
• Study Start: January 27, 2017
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: December 29, 2022
• Results First Posted: December 29, 2022

Record last verified: 2022-12

Locations

US (3)