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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT07229560
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-55 years;
2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-28 kg/m2;
3. Normal or no clinically significant medical history, ECGs, vital signs and laboratory tests;
4. Take contraception.
Exclusion Criteria:
1. Any serious clinical diseases or medical history or diseases that affect the absorption, metabolism and/or excretion of the study drug;
2. Severe infection, severe trauma or major surgery;
3. Any medications in the two weeks before screening or baseline period;
4. History of blood donation or severe blood loss;
5. Have been vaccinated within 3 months before the screening or baseline period;
6. History of smoking or excessive alcohol or drug abuse;
7. History of excessive amounts of tea, coffee or caffeinated beverages, special foods; or have special dietary requirements;
8. Other situations in which the researcher judges unsuitable.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07229560
Study Brief:
Protocol Section:
NCT07229560