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 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
NCT ID:
NCT05991661
Eligibility Criteria:
Inclusion Criteria:
1. Healthy subjects who voluntarily sign a written informed consent form (ICF) and are able to complete the study as required by the protocol;
2. Male or female subjects aged 18 to 65 years (inclusive);
3. Subjects with BMI between 18 and 28 kg/m2 (inclusive);
4. Subjects with normal or abnormal but not clinically significant results of vital signs, physical examinations, laboratory tests, 12-lead ECGs and QTcF ≤ 450 ms;
5. Subjects who did not use any prescription or over-the-counter medications within two weeks prior to dosing;
6. Subjects who agree to have no child-bearing plans and to voluntarily take effective contraception measures during the study and within 6 months after the end of the study.
Exclusion Criteria:
1. Pregnant or lactating women;
2. Subjects with clinically significant diseases that may affect the subject's participation in this study within 5 years as judged by the investigator: including but not limited to gastrointestinal, renal, liver, lung, neurological, blood, endocrine, tumor, metabolic, psychiatric or cardio-cerebrovascular diseases, etc.;
3. Subjects with history of autoimmune diseases, known family history of inherited immunodeficiency disorders, or recurrent infections suggestive of possible immunodeficiency;
4. Subjects with active infections requiring hospitalization or IV antibiotic treatment within 3 months prior to dosing, or bacterial, viral and fungal infections with clinical symptoms within 1 week;
5. Subjects with a history of active tuberculosis or subjects with active or latent tuberculosis infection at screening;
6. Subjects with positive HBsAg in 5 items of hepatitis B serology (if HBsAg is negative, HBcAb is positive, and HBsAb is negative, HBV DNA quantitative test is required to be performed \[the subject will be excluded if the test result is positive\]), positive hepatitis C antibody, treponema pallidum antibody, HIV antigen/antibody;
7. Subjects who plan to receive live or live attenuated vaccines within 4 weeks prior to dosing or during the study;
8. Subjects who have participated in clinical studies of any drug or device within 3 months or 5 half-lives of the investigational product (whichever is longer) prior to dosing;
9. Subjects who are allergic to the investigational product or any component of the formulation of the investigational product or have a history of allergy to protein drugs;
10. Subjects who have consumed more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 6 weeks prior to screening or have taken alcoholic products 1 day before dosing;
11. Subjects who have a history of abuse of other drugs within 5 years prior to screening, or who have a positive urine drug screen result;
12. Subjects who have a smoking history (\> 5 cigarettes/day) within 3 months prior to screening;
13. Subjects who have blood donation or blood loss of more than 450 mL within 8 weeks prior to screening, or blood donation of more than 200 mL or blood loss of more than 300 mL within 1 month;
14. Subjects with obstructed venous access or intolerance to venipuncture;
15. Subjects who are considered inappropriate for the study by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05991661
Study Brief:
Protocol Section:
NCT05991661