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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT07232758
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male and female subjects, aged 18 to 45 years.
2. Body weight and Body Mass Index (BMI) within a specified range (e.g., BMI 19.0-26.0 kg/m²).
3. Agreement to use highly effective contraception during the study period and for a specified duration after the last dose. No plans for pregnancy, sperm/egg donation.
4. Voluntarily provides written informed consent to participate in the study.
Exclusion Criteria:
1. History of significant allergies to any food or drug, especially to the investigational product, its components, or drugs of a similar class.
2. History or current presence of any clinically significant disease in major organ systems (e.g., cardiovascular, hepatic, renal, neurological, etc.).
3. Any clinically significant abnormalities found during screening assessments (including physical examination, vital signs, and laboratory tests).
4. Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
5. Evidence of impaired renal function based on laboratory tests (e.g., eGFR, serum creatinine).
6. Positive screening for specified infectious diseases (e.g., HIV, HBV, HCV, Syphilis).
7. Use of any medication (including prescription, OTC, and herbal) within a specified period before the study.
8. Excessive consumption of certain beverages (e.g., caffeine, grapefruit juice) or inability to adhere to dietary restrictions.
9. History of major surgery within the past 3 months or planned surgery during the study period.
10. Participation in another clinical trial within the past 3 months.
11. Significant blood loss, blood donation, or transfusion within the past 3 months.
12. History of excessive alcohol consumption or unwillingness to abstain during the study.
13. History of heavy smoking or unwillingness to abstain during the study.
14. History of drug abuse or positive drug screening test.
15. Inability to tolerate venous access or history of fainting during blood draws.
16. Inability to comply with the standardized diet provided during the study.
17. Any other reason that, in the opinion of the investigator, makes the subject unsuitable for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07232758
Study Brief:
Protocol Section:
NCT07232758