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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT05719961
Eligibility Criteria:
Inclusion Criteria:
1. Male subjects aged 18 \~ 45 (including the boundary. value)(Part I). Subjects aged 18 \~ 45 (including the boundary value), male or female(Part II).
2. Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
3. Body Mass Index (BMI) between 18.0-26.0 kg/m2 (both inclusive).
Exclusion Criteria:
1. A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug.
2. Have a history of hypertension.
3. Severe systemic infectious diseases within 1 month before screening.
4. Use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and Chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening.
5. Presence of any abnormal and clinically significant laboratory tests.
6. 12-lead electrocardiogram (ECG) showed abnormal and clinically significant.
7. Known or suspected history of drug abuse or positive urine drug screening test within screening period.
8. Those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (The elder shall prevail), who participated in clinical trials are defined as random, prior to screening;
9. Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05719961
Study Brief:
Protocol Section:
NCT05719961