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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT06822166
Eligibility Criteria:
Inclusion Criteria:
1. healthy adult male and female subjects aged 18-45 years (inclusive);
2. Body weight: body mass index (BMI) between 18.0 and 30.0 kg/m2 (including the cut-off value), with a body weight of at least 50 kg for male subjects and 45 kg for female subjects;
3. The subjects had good communication with the investigators, signed the informed consent form voluntarily, and were able to complete the trial according to the protocol.
Exclusion Criteria:
\-
Auxiliary examination:
1. if the results of physical examination, vital signs, 12-lead electrocardiogram, cortisol test, and laboratory tests are abnormal and clinically meaningful;
2. potentially difficult airway;
3. hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
Medication history:
4. use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening;
5. use of any prescribed medication within 14 days before dosing;
6. use of over-the-counter drugs, Chinese herbal medicines or food supplements such as vitamins and calcium supplements within 7 days before administration;
History of disease and surgery:
7. any history of clinically severe illness or any disease or condition that the investigator believes may affect the trial results;
8. patients with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;
9. a history of severe cardiovascular disease, including but not limited to a history of organic heart disease, such as heart failure, myocardial infarction, angina, malignant arrhythmia, such as a history of torssion ventricular tachycardia, ventricular tachycardia, long QT syndrome, or symptoms of long QT syndrome and family history;
10. underwent any surgery within 6 months before screening;
11. allergic constitution; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;
Living habits:
12. heavy drinking or regular drinking in the 6 months before screening, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Or with a positive alcohol breath test at baseline;
13. smoked more than 5 cigarettes per day in the 3 months before screening or could not quit smoking during the study;
14. had a history of drug abuse or drug abuse within 3 months before screening; Or the baseline urine drug test was positive;
15. habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeinated beverages and inability to quit during the trial;
Others:
16. those who have difficulty in blood collection, can not tolerate venipuncture or arterial blood collection;
17. participated in any other clinical trial within 3 months before screening;
18. vaccinated within 1 month before screening or planned to be vaccinated during the trial period;
19. pregnant or lactating women;
20. childbearing or sperm donation plan during the trial and half a year after the completion of the trial, or do not agree that the subjects and their spouses should take strict contraceptive measures during the trial and half a year after the completion of the trial;
21. had blood loss or donation \>400 mL within 3 months before screening, or received blood transfusion within 1 month;
22. subjects with any factors considered by the investigator to be ineligible for the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06822166
Study Brief:
Protocol Section:
NCT06822166