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



Status:Completed
Conditions:Other Indications, Dental
Therapuetic Areas:Dental / Maxillofacial Surgery, Other
Healthy:No
Age Range:12 - 75
Updated:10/21/2018
Start Date:January 27, 2017
End Date:March 29, 2017

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

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.

A single-blind, randomized, placebo-controlled Phase 2 study to evaluate the safety and oral
microbiology of C16G2 Varnish application in male and female dental subjects 12-75 years of
age. This multi-center study will evaluate multiple study drug administrations of C16G2
Varnish or Placebo Varnish.

The study will enroll subjects into up to three study arms. Up to 33 subjects will receive
multiple doses of study drug applied with a small brush typically used in dental varnish
administration. Subjects will be enrolled in an 8:3 ratio. The Sponsor will perform unblinded
microbiology review on an ongoing basis to determine whether to enroll additional 11 subjects
into the next dose cohort or to terminate enrollment based on microbiology data.

Inclusion Criteria:

1. Males and females, 12-75 years of age

2. 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

3. 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

4. Negative urine pregnancy test in all females of childbearing potential (past menarche)

5. 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

6. 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.

7. Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT
having restorations, crowns or sealants

8. Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes

9. Have a salivary S. mutans of 1.0 x 10^5 CFUs/mL or greater at Screening using mitis
salivarius-bacitracin (MSB) agar plating

10. Willing to refrain from using non-study dentifrice and other non-study oral care
products (oral care rinses, fluoride products, etc.) during the study

11. Willing to postpone elective dental procedures (e.g., dental cleanings) between
Screening and final post-treatment visit (End of Study or Early Termination)

12. Willing and able to comply with oral hygiene and diet instructions

13. 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

Exclusion Criteria:

1. Advanced periodontal disease

2. 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

3. Partially erupted teeth where the entire crown is not erupted or an operculum is
present

4. 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

5. Pathologic lesions of the oral cavity (suspicious or confirmed)

6. 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

7. 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

8. Medical history indicating the woman is pregnant, breastfeeding/lactating or has a
positive urine pregnancy test

9. 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)

10. 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
We found this trial at
3
sites
Irving, Texas 75063
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Irving, TX
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2700 Brown Trail
Bedford, Texas 76021
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Bedford, TX
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Kalispell, Montana 59901
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Kalispell, MT
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