Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT02644135
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent
2. Ages between 18-45 years, inclusive
3. Non-tobacco/nicotine use (at least 3 months)
4. BMI of 17-35 kg/m2 inclusive
5. Able to comply with all study procedures and follow-up
6. Healthy on the basis of screening medical exam, blood chemistries, hematology, and serum pregnancy tests for females (at screening )
7. Non-pregnant or breast-feeding
Exclusion Criteria:
1. History of current use of narcotics, or recreational drug use.
2. Use of \> 7 alcoholic beverages in 1 week
3. Any acute illness such as asthma, cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal (including eating disorder), endocrine/metabolic, neurologic, dermatologic, or psychiatric disease.
4. Treatment with another investigational product in the past 30 days
5. Immunocompromised status including HIV by history
6. Use of any other intra-oral product (especially antiseptic).
7. Intended use of mouthwash during study duration
8. Laboratory (screening) of creatinine \> 1.5 X ULN, hemoglobin \< 10.5 g/dL, platelet count ≤ 99,000/mm3, absolute neutrophil count ≤1200/ mm3, serum glucose ≥ 150 mg/dl (Subject can enroll prior to receiving lab results. Subject will be contacted if lab results are an exclusion and discontinue from study)
9. Use of any systemic antibiotic or antifungal within 30 days of screening
10. Prior or current history of seasonal allergies, chronic sinusitis or rhinitis
11. Allergy to any component of Halo
12. Oral lesions
13. Dentures
14. Dental Treatment currently in progress (implants, root canals, complex restorative procedures)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02644135
Study Brief:
Protocol Section:
NCT02644135