| Eligibility |
Inclusion Criteria:
- Male or female 18 - 65 years of age;
- In good health as determined by medical history, physical and dental examination,
vital signs and clinical laboratory safety assessment;
- Agree to delay any elective dentistry including dental prophylaxis until the study has
been completed;
- Agree to refrain from supplements containing arginine throughout the duration of the
study;
- In the case of females of childbearing potential (unless surgically sterilized
[hysterectomy, bilateral oophorectomy, tubal ligation] or are postmenopausal for at
least 12 months), are using one acceptable form of birth control
(oral/implant/injectable/transdermal contraceptives, intrauterine device (IUD), condom
with spermicide, diaphragm with spermicide, partner's vasectomy). Abstinence or
vasectomies are acceptable if the female subject agrees to implement an acceptable
form of birth control if her lifestyle/partner changes;
- For females of childbearing potential, have a negative serum pregnancy test (SPT) at
the Screening visit and a negative urine pregnancy test (UPT) on Day -2 prior to
randomization, and agree to submit to a SPT at the end of study (EOS) visit;
- Are free of any systemic or dermatologic disorder, which, in the opinion of the
Principal Investigator (PI), will interfere with the study results or increase the
risk of adverse events (AEs); and
- Read, understand, and provide signed informed consent.
Exclusion Criteria:
- A female who is pregnant, plans to become pregnant during the study, or is
breastfeeding a child;
- Are actively being treated for periodontitis, gingivitis or caries;
- Have severe periodontal disease, as characterized by purulent exudates, generalized
mobility, or severe recession;
- Any clinically significant central nervous system, cardiac, pulmonary, renal,
gastrointestinal (GI), endocrinological, respiratory, or metabolic conditions (or
history), or other pathological or physiological conditions, that might interfere with
the study results in the investigator's opinion;
- Any condition which, in the investigator's opinion, puts the subject at significant
risk, could confound the study results, or may interfere significantly with the
subject's participation in the study;
- Have known or suspected allergies to oral care products, toothpaste, or ingredients in
toothpaste;
- Immunization within 10 days of Day 1;
- Anticipated need for surgery or hospitalization during the study;
- Consumed alcohol within 48 hours prior to Day 1 or refuses to abstain from alcohol
throughout the duration of the study;
- History of heavy smoking (i.e., more than 10 cigarettes a day or the tobacco/nicotine
equivalent) within 3 months of screening or refuses to abstain from tobacco or
nicotine-containing products throughout the duration of the study;
- Consumed caffeine (i.e., coffee, tea, caffeinated soda, chocolate) within 48 hours
prior to Day 1 or refuses to abstain from caffeine throughout the duration of the
study;
- Donation or loss of blood (excluding volume drawn at screening) of = 450 mL within 3
months of Day 1;
- Active or lifetime infection (e.g., negative test for human immunodeficiency virus
(HIV) and hepatitis, and no history of tuberculosis and syphilis) or a history of
severe infection during the 30 days prior to screening;
- Chronic or current active infectious disease requiring systemic antibiotics,
antifungal, or antiviral treatment;
- Is unwilling or unable to refrain from using prescription medications for 30 days
prior to Day 1 or over the counter medications, herbal preparations, and supplements
for 14 days prior to Day 1 (excluding permitted forms of contraception and occasional
use of acetaminophen [up to 2 g in 24 hours]);
- Inability or unlikeliness of the subject to comply with the dose schedule and study
evaluations, in the opinion of the investigator;
- Is currently participating in any clinical trial;
- Has received any investigational drug(s) within 30 days or 5 half-lives, whichever is
longer, prior to study Day 1;
- Any condition that would, in the investigator's judgment, interfere with full
participation in the study, including attending required study visits; pose a
significant risk to the subject; or interfere with interpretation of study data;
- Inability of the subject (or legally authorized representative) to comprehend the
electronic informed consent form (eICF) or unwillingness to sign the eICF; and/or
- Subject meets eligibility criteria, but study is filled
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