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:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT05242718
Eligibility Criteria:
Inclusion Criteria:
* Subjects meeting all of the following criteria will be considered for admission to the study:
1. Healthy subjects between 60-70 years of age.
2. Availability of the subject for one of the forecasted study periods and willingness of the subject to adhere to protocol requirements, as evidenced by a signed Informed Consent Form
3. Have a BMI between18.5-29.9
4. Agrees not to use any over the counter, prescription, health supplement or dietary supplement from screening until the end of the study period.
5. Agrees to refrain from vaccinations throughout the study period.
6. Able to maintain their current routine level of physical activities throughout the study period
7. Willing and able to agree to the requirements and restrictions of this study (including but not limited to: not consuming more than 2 standard alcoholic beverages a day \[A standard alcoholic beverage is defined as 12 ounces of beer, five (5) ounces of wine, or 1.5 ounces of liquor\]), not consuming cannabis products of any type.
8. In good health as determined by lack of clinically significant abnormalities in health assessments (history, physical examination, laboratory tests) performed at screening as judged by the physician.
9. Women will be those without child bearing potential
Exclusion Criteria:
* Subjects meeting any of the following criteria will not be eligible for the study:
1. Have a known sensitivity or allergy to any of the study products
2. Self-reported smokers
3. Receipt or use of an investigational product in another research study within 30 days prior to Baseline (Visit 2) or currently participating in another research study
4. Receipt of a vaccination of any type within 60 days prior to the baseline visit.
5. Difficulty with venipuncture and/or poor venous access
6. Any major surgery within 1 year of study drug administration
7. Anticipated major surgeries or major life events (major travel or change in lifestyle conditions) forecast to occur during the anticipated study periods
8. Blood transfusion within 8 weeks of study drug administration
9. Donation of blood or plasma to a blood bank or clinical study within 8 weeks of study drug administration
10. Any clinically significant abnormalities in vital signs, as judged by the investigator.
11. Hypertension or on blood pressure lowering medication
12. Subjects with medical conditions that might interfere with participation in the study or interpretation of the study results. These include serious chronic diseases such as diabetes, neurologic or psychiatric disease (including any previous suicidal symptoms or suicide attempts), cardiovascular disease, gastrointestinal disease, pulmonary disease, cancer, autoimmune diseases, immunodeficiencies, hepatic or renal diseases.
13. History of prior significant cardiovascular disease, coronary artery disease, cardiovascular surgery, significant valvular disease, heart failure, arrhythmias, sick sinus syndrome or stroke
14. History of clinically significant cerebrovascular, metabolic, pulmonary, neurological, hematological, autoimmune, endocrine disorders, including individuals with Type I or Type II diabetes, or other clinically significant medical condition that, in the opinion of the Investigator, may preclude safe study participation
15. History of immune disorder (such as HIV/AIDS), hepatitis B or hepatitis C, or positive immune disorder diagnosis
16. History of alcohol or substance abuse in the 12 months prior to screening
17. History of cannabis product use, including Cannabidiol (CBD), in the 3 months prior to screening
18. Any other medical or social condition that, in the judgment of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data or otherwise interfere with achieving the study objectives.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
70 Years
Study:
NCT05242718
Study Brief:
Protocol Section:
NCT05242718