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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05391360
Eligibility Criteria:
Inclusion Criteria:
Health volunteer:
1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
2. subjects and must be 18 to 45 years of age inclusive.
3. Body weight ≥ 45 kg and body mass index（BMI）between 18 and 28 kg / m\^2, inclusive.
4. Physical examination and vital signs without clinically significant abnormalities.
Patients with chronic hepatitis B:
1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
2. subjects and must be 18 to 65 years of age inclusive.
3. Body mass index（BMI）between 18 and 32 kg / m\^2, inclusive.
4. No cirrhosis.
Exclusion Criteria:
Health volunteer:
1. Use of \>5 cigarettes per day during the past 3 months.
2. History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).
3. Donation or loss of blood over 450 mL within 3 months prior to screening.
Patients with chronic hepatitis B:
1. AFP\>50 ng/mL.
2. INR\>1.5.
3. Positive for Viral hepatitis C, HIV and syphilis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05391360
Study Brief:
Protocol Section:
NCT05391360