Intervention: BLXA4
Trial phase: Phase 1 | Phase 2
SMILES: CCCCC[C@@H](O)/C=C/c1ccccc1/C=C/[C@@H](O)[C@@H](O)CCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: The topical oral rinse dosage form of BLXA4-ME (also known as ClinRinse-1) will consist of drug substance prepared at a concentration of 1.0 μM in an aqueous vehicle solution

BLXA4: BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate.
Eligibility criteria:
Inclusion Criteria:

Signed consent form
Good general health as evidenced by medical history
Age 18 - 65
Must have a stable address and be available for the duration of the study
Must have a minimum of 20 natural teeth, excluding third molars
Must have a mean full mouth MGI of at least 2.0
Must be willing to use prescribed oral hygiene procedures and products
Medications for chronic conditions must be stable for at least 3 months prior to enrollment
Women of reproductive potential must use licensed hormonal contraception or double barrier methods
Men of reproductive potential must agree to use condoms
Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, and total bilirubin) levels equal to or less than 1.5 times the upper limit of normal
Serum creatinine levels equal to or less than the upper limit of normal;
Subjects with complete blood count levels within 10% of the normal laboratory range and erythrocyte sedimentation rate equal to or less than 2 times the upper limit of normal.

Exclusion Criteria:

Presence of orthodontic appliances or removable partial dentures
Presence of a soft tissue tumor of the oral cavity
Presence of gross plaque or calculus (≥ 75% of tooth surfaces)
Presence of extensive restorations that could affect the marginal gingiva (at the investigators' discretion)
Preexisting oral pathology, including carious lesions requiring immediate treatment or ulcerations of the mucosa
Current participation in another clinical trial or product test
Pregnant or breast feeding
Residence in the same household as a subject currently enrolled in the study (due to potential blinding and compliance issues)
Concomitant endodontic therapy or periodontal therapy other than prophylaxis within the past 6 months
History of early onset periodontitis or acute necrotizing ulcerative gingivitis
Chronic disease with concomitant oral manifestations, such as autoimmune or immunosuppressive diseases (e.g., human immunodeficiency virus, severe combined immunodeficiency, neutropenia, juvenile arthritis, systemic lupus erythematosus, sickle cell anemia, Crohn's disease, rheumatoid arthritis, Sjögren's syndrome) or immunocompromised status due to cancer chemotherapy, hematopoietic stem cell or solid organ transplant, head and neck radiotherapy, splenectomy, chronic steroid usage
Recent history of chronic alcohol consumption of more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer, or five 5 ounce servings of wine per day
Tobacco use (former tobacco users may be enrolled, provided they have been tobacco-free for one year or more)
Diabetes mellitus
Subjects with urinalysis results suggestive of infection (if a subject meets this criterion, he/she may be rescreened for study participation when he/she no longer meets this exclusion criterion)
Medical conditions that the investigator considers significant and that may interfere with the examination or the safety of the subject
Chronic use (2 weeks or more) of medication known to affect periodontal status within one month of enrollment (such as ≥81mg aspirin, phenytoin, calcium antagonists such as nifedipine, NSAIDs, coumarin, cyclosporine, ≥10 mg/day atorvastatin or equivalent dose of another statin [Subramanian et al, 2013]);
Treatment with antibiotics within one month prior to enrollment
Medical condition for which antibiotic treatment during the study period is likely or a condition for which antibiotic prophylaxis is recommended before dental procedures (American Heart Association guidelines of 2007 will be followed)
Known hypersensitivity to any component of the test or placebo products
Anything that, in the opinion of the investigator, would place the subject at increased risk or prevent the subject from fully complying with or completing the study -