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

NCT03052842 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C3J16-S205-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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..

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (2)

• Antimicrobial Activity of C16G2

  To assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. The antimicrobial activity of crystal violet dye, high sucrose content, sodium tellurite and bacitracin effectively prevent the growth of all bacteria except for streptococci. Further differentiation of streptococci is accomplished by observing colony morphology. S. mutans grows in large blue colonies with dry frosted tops or pale blue gumdrops and can be differentiated from other bacterial colonies.

  Measured up to 1 months post last study drug administration

• Total Oral Bacterial Levels

  To assess total bacteria in saliva and dental plaque post study drug administration using total bacteria CFUs using Todd Hewitt (TH) agar plating and the log transformed changes from baseline Total Bacteria levels in dental plaque and saliva including N, mean, SD, median and range at each assessment time point following the first administration of C16G2.

  Measured up to 1 months post last study drug administration

Secondary Outcomes (1)

• To Evaluate the Safety and Tolerability of Multiple C16G2

  Up to 1 week post last study drug administration

Study Arms (6)

Arm 1A: 9.2 mg C16G2

EXPERIMENTAL

Study subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.

Drug: C16G2 Strip

Arm 1B: 9.2 mg Placebo

PLACEBO COMPARATOR

Study subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.

Other: Placebo Strip

Arm 2A: 18.4 mg C16G2

EXPERIMENTAL

Study subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.

Drug: C16G2 Strip

Arm 2B: 18.4 mg Placebo

PLACEBO COMPARATOR

Study subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.

Other: Placebo Strip

Arm 3A: 36.8 mg C16G2

EXPERIMENTAL

Study subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects).

Drug: C16G2 Strip

Arm 3B: 36.8 mg Placebo

PLACEBO COMPARATOR

Study subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects).

Other: Placebo Strip

Interventions

C16G2 Strip DRUG

Antimicrobial Peptide

Arm 1A: 9.2 mg C16G2; Arm 2A: 18.4 mg C16G2; Arm 3A: 36.8 mg C16G2

Placebo Strip OTHER

Placebo

Arm 1B: 9.2 mg Placebo; Arm 2B: 18.4 mg Placebo; Arm 3B: 36.8 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 are 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.
• 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
• Vantage Data Designs, Inc.: collaborator
• E Squared Trials and Registries, Inc.: collaborator
• Agility Clinical, Inc.: collaborator

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

Model Details: Three dose groups will be enrolled in an ascending dose escalation manner

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: February 9, 2017
• Primary Completion: April 5, 2017
• Study Completion: April 5, 2017
• Last Updated: December 22, 2022
• Results First Posted: December 22, 2022

Record last verified: 2022-12

Locations

US (3)