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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT07230418
Eligibility Criteria:
Inclusion Criteria:
1. Able to comprehend and willing to sign an informed consent form (ICF);
2. Male and female healthy subjects with an age range between 18 and 55 years (inclusive);
3. Body mass index between 18.0 and 32.0 kg/m2 (inclusive), and the body weight is ≥ 50 kg for men and ≥ 45 kg for women;
4. For healthy subjects, no clinically significant abnormalities;
5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods.
Exclusion Criteria:
1. Known medical history or clinical manifestation of circulatory, endocrine, neurological, digestive, respiratory, hematological, immunological, psychiatric diseases, metabolic disorders, or any other condition that may interfere with the trial results, as determined by the Investigator;
2. Any condition or disease that may affect drug absorption, distribution, metabolism, or excretion, as determined by the Investigator;
3. History of recurrent drug allergies, or a physician-diagnosed and treatment-requiring allergic disease, or known allergy to any component of the investigational product;
4. History of an infection requiring systemic antimicrobial therapy within 2 weeks prior to screening or within 2 weeks before the first dose of the investigational product.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07230418
Study Brief:
Protocol Section:
NCT07230418