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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07331194
Eligibility Criteria:
Inclusion Criteria:
Trial participants must meet all of the following criteria for enrollment:
1. Participants can communicate well with the investigator, must voluntarily sign the ICF and agree to comply with the requirements of the study protocol;
2. Male and female healthy participants aged 18-45 years (inclusive);
3. Body weight ≥ 45 kg (females) or ≥ 50 kg (males), body mass index (BMI) 19-26 kg/m2 (inclusive);
4. Study participants must commit to using highly effective contraception for both themselves and their sexual partners during the study, and for 180 days after the end of the last study dose, and must not engage in sperm donation, egg donation, or have birth plan.
Exclusion Criteria:
Study participants must be excluded from this study if one of the following conditions is met:
1. Abnormal and clinically significant results of vital signs, physical examination, 12-lead ECG, chest X-ray (frontal and lateral), laboratory tests (including hematology, blood chemistry, urinalysis, etc.) or serum creatinine above the upper limit of normal at screening;
2. Positive for any of the HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody;
3. History or current evidence of severe or chronic metabolic/endocrine, hepatic, renal, hematological, pulmonary, immunological, cardiovascular, gastrointestinal, genitourinary, neurological or psychiatric diseases;
4. Prior history of hypertension;
5. Prior history of severe gastrointestinal diseases such as dysphagia, active gastric ulcers, etc., resulting in inability to take oral medication or disorders in absorption of oral medication
6. Prior history of gastrointestinal surgery, renal surgery, cholecystectomy, etc. that, in the judgment of the investigator, may affect drug absorption or excretion;
7. Prior history of drug allergy, or acute allergic rhinitis or food allergy within 2 weeks before screening, or allergy to the active ingredients or excipients of the study drug;
8. Use of any prescription drugs and Chinese herbal medicines within 30 days prior to the first dose;
9. Use of any over-the-counter drugs, vitamins, and health products within 14 days prior to the first dose;
10. Consumption of more than 10 cigarettes per day within 3 months before screening, or those who cannot quit smoking during the study;
11. Regular alcohol consumption within 6 months before screening, that is, those who drink more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or those who cannot abstain from alcohol during the study, or those who are positive for alcohol breath test;
12. History of drug abuse or recreational use, or positive for urine drug abuse screen;
13. Blood donation (including blood component donation) or blood loss ≥ 400 mL within 3 months prior to screening, blood products within 2 months prior to screening, blood donation (including component blood donation) or lost blood ≥ 200 mL within 1 month prior to screening, or a plan to donate blood or blood components during the study or within 1 month after the end of the study;
14. Difficulty in blood collection, or a history of needle phobia or blood phobia, or intolerance to blood sampling via venipuncture, or poor evaluation of venous blood collection;
15. Participants who participated in clinical studies of other drugs/medical devices and received investigational drugs within 3 months prior to screening;
16. Participants who have consumed foods, juices or drinks containing alcohol, grapefruit, Seville oranges and caffeine within 72 hours before the first dose, or cannot avoid them during the study;
17. Those who have received live vaccines within 8 weeks prior to screening or have plans to vaccinate during the clinical study;
18. Those who have special requirements for diet and cannot accept unified dietary arrangements;
19. Pregnant or lactating women, or those with blood pregnancy test results above the upper limit of normal during screening, or women with unprotected sex within 2 weeks prior to dosing;
20. The study participant, based on the judgment of the investigator, has any other diseases or conditions that may affect the normal completion of the study or the evaluation of study data, or other conditions that make him/her unsuitable for participation in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07331194
Study Brief:
Protocol Section:
NCT07331194