A Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Dental Strip Application
Study Details
Study Description
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..
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
A single-blind, randomized, placebo-controlled, phase 2 study to evaluate oral microbiology and safety of multiple C16G2 Strip applications in male and female dental subjects 12-75 years of age.
The study will compare multiple study drug administrations of 9.2 mg, 18.4 mg, and 36.8 mg C16G2 Strip or Placebo in Study Arms 1 through 3, respectively. Enrollment of subjects in Study Arms 1 through 3 will occur sequentially in an ascending dose-escalation manner. Before dosing of study drug, eligible subjects will receive professional dental prophylaxis between Days -7 and -2. Subjects will receive 11 doses administered over approximately two weeks. Each subject will receive a single dose on Day 0, followed by 5 days of AM and PM dosing starting on Day 7. To evaluate the durability of S. mutans suppression, study subjects will be followed for microbiology for up to 1 month after the last study drug administration.
Clinic visits include Visit 1 (Screening/Days -30 to -1), Visit 2 (Prophylaxis/Day -7 to -2), Eligibility Confirmation & Baseline Visit 3, Follow-up Visits 4-7 (Safety and Microbiology), Visits 8-17 (Study Drug Administration), Follow-up Visits 18-20 (Safety and Microbiology) and Follow-up Visits 21-22 (Microbiology only).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Arm 1 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
Antimicrobial Peptide
Other: Placebo Strip
Placebo
|
| Other: Arm 2 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
Antimicrobial Peptide
Other: Placebo Strip
Placebo
|
| Other: Arm 3 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
Antimicrobial Peptide
Other: Placebo Strip
Placebo
|
Outcome Measures
Primary Outcome Measures
- Antimicrobial activity against S. mutans [Measured up to 1 months post last study drug administration]
Streptococcus mutans levels will be evaluated by measuring colony forming unit (CFU)/mL counts in saliva and dental plaque
- Antimicrobial activity against total bacteria [Measured up to 1 months post last study drug administration]
Total bacterial levels will be evaluated by measuring cfu/ml counts of salivary and plaque bacteria
Secondary Outcome Measures
- Safety as measured by incidence of adverse events, changes in vital signs, oral cavity assessments, and targeted physical exams . Tolerability as measured by the number of study drug discontinuations and subjects discontinued due to adverse events [Up to 1 week post last study drug administration]
Evaluation of adverse events, oral cavity assessments, targeted physical exams, and vital signs. Tolerability as measured by study drug discontinuations and discontinuations due to adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Negative urine pregnancy test in all females of childbearing potential (past menarche)
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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
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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.
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Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT having restorations, crowns or sealants
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Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes
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Have a salivary S. mutans of 1.0 x 10^5 CFUs/mL or greater at Screening using mitis salivarius-bacitracin (MSB) agar plating
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Willing to refrain from using non-study dentifrice and other non-study oral care products (oral care rinses, fluoride products, etc.) during the study
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Willing to postpone elective dental procedures (e.g., dental cleanings) between Screening and final post-treatment visit (End of Study or Early Termination)
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Willing and able to comply with oral hygiene and diet instructions
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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:
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Advanced periodontal disease
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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
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Partially erupted teeth where the entire crown is not erupted or an operculum is present
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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
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Pathologic lesions of the oral cavity (suspicious or confirmed)
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Full dentures or permanent orthodontic appliances, e.g., braces, buccal or lingual brackets.
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | John F. Pittaway, DMD | Kalispell | Montana | United States | 59901 |
| 2 | Jacqueline Kleven, DDS | Bedford | Texas | United States | 76021 |
| 3 | Anthony Henegar, DDS, PA | Irving | Texas | United States | 75063 |
Sponsors and Collaborators
- Armata Pharmaceuticals, Inc.
- Vantage Data Designs, Inc.
- E Squared Trials and Registries, Inc.
- Agility Clinical, Inc.
Investigators
- Principal Investigator: John Pittaway, DMD, Plaza West II Dental Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C3J16-S205-00