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 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT07275918
Eligibility Criteria:
Inclusion Criteria:
1. Able to correctly understand and sign the informed consent form in writing.
2. Male or female participants.
* For healthy participants: aged 18-55 years old (inclusive of the cut-off values).
* For participants with chronic hepatitis B (CHB): aged 18-65 years old (inclusive of the cut-off values).
3. Body Mass Index (BMI) meets the following requirements.
* For healthy participants: within the range of 18-28 kg/m² (inclusive of the cut-off values).
* For participants with chronic hepatitis B (CHB): within the range of 18-32 kg/m² (inclusive of the cut-off values).
4. During the screening period, the results of the following examinations are either normal or abnormal but not clinically insignificant:
\- Clinical laboratory tests: complete blood count, blood biochemistry, coagulation function, urine routine. Thyroid function test. 12-lead electrocardiogram (ECG). Abdominal ultrasound. Posteroanterior chest X-ray.
5. For participants with chronic hepatitis B (CHB): documented hepatitis B virus (HBV) infection for at least 6 months before screening, with positive hepatitis B surface antigen (HBsAg) and/or positive HBV deoxyribonucleic acid (HBV DNA).
6. For female participants of childbearing potential: must not be pregnant or lactating, and agree to use effective contraception during the study period.
7. For male participants of childbearing potential: agree to use effective contraception during the study period to ensure effective contraception for their sexual partners.
Exclusion Criteria:
1. Participants with concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis infection; or those previously diagnosed with hepatitis A, D, or E who have not been cured.
2. Participants with severe diseases, including but not limited to diseases of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, thyroid, gastrointestinal, respiratory, metabolic, and skeletal systems, as well as a history of malignant tumors.
3. Participants with severe mental illness or uncontrolled mental disorders, including but not limited to schizophrenia, bipolar disorder, or depression.
4. Participants with a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening, who are deemed unsuitable for the study by the investigator.
5. Participants who have undergone major surgery within 6 months before screening, or plan to undergo surgery during the study period.
6. Participants with severe infection or trauma within 4 weeks before screening.
7. Participants with a severe allergic constitution, or a confirmed allergy to this product or its formulation components.
8. Participants who smoked more than 5 cigarettes per day or the equivalent amount of tobacco within 3 months before screening.
9. Participants deemed unsuitable for the trial by the investigator due to other factors.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07275918
Study Brief:
Protocol Section:
NCT07275918