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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT07301333
Eligibility Criteria:
Inclusion Criteria:
1. Aged between 18 and 55 years old (based on the time of signing the informed consent form), both males and females are eligible.
2. The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m².
3. Female subjects must be non-pregnant or non-childbearing potential;
4. Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.
Exclusion Criteria:
1. History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease;
2. Known or suspected hypersensitivity to trial product(s) or related products;
3. 12-lead ECG demonstrating QTcF \>450 msec or history or risk factors for QT prolongation;
4. Blood donation of more than 200 mL within the last 6 months
5. Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 7 half-lives;
6. Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse.
7. Previous administration with an investigational product (drug or vaccine) within 3 months;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07301333
Study Brief:
Protocol Section:
NCT07301333