Phase
Condition
Hepatitis B
Treatment
SA1211 injection
SA1211 injection placebo
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able to correctly understand and sign the informed consent form in writing.
Male or female participants.
For healthy participants: aged 18-55 years old (inclusive of the cut-offvalues).
For participants with chronic hepatitis B (CHB): aged 18-65 years old (inclusive of the cut-off values).
- Body Mass Index (BMI) meets the following requirements.
For healthy participants: within the range of 18-28 kg/m² (inclusive of thecut-off values).
For participants with chronic hepatitis B (CHB): within the range of 18-32kg/m² (inclusive of the cut-off values).
- During the screening period, the results of the following examinations are eithernormal or abnormal but not clinically insignificant:
- Clinical laboratory tests: complete blood count, blood biochemistry, coagulationfunction, urine routine. Thyroid function test. 12-lead electrocardiogram (ECG).Abdominal ultrasound. Posteroanterior chest X-ray.
For participants with chronic hepatitis B (CHB): documented hepatitis B virus (HBV)infection for at least 6 months before screening, with positive hepatitis B surfaceantigen (HBsAg) and/or positive HBV deoxyribonucleic acid (HBV DNA).
For female participants of childbearing potential: must not be pregnant orlactating, and agree to use effective contraception during the study period.
For male participants of childbearing potential: agree to use effectivecontraception during the study period to ensure effective contraception for theirsexual partners.
Exclusion
Exclusion Criteria:
Participants with concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis infection; or those previously diagnosed with hepatitis A, D, or Ewho have not been cured.
Participants with severe diseases, including but not limited to diseases of thenervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic,thyroid, gastrointestinal, respiratory, metabolic, and skeletal systems, as well asa history of malignant tumors.
Participants with severe mental illness or uncontrolled mental disorders, includingbut not limited to schizophrenia, bipolar disorder, or depression.
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.
Participants who have undergone major surgery within 6 months before screening, orplan to undergo surgery during the study period.
Participants with severe infection or trauma within 4 weeks before screening.
Participants with a severe allergic constitution, or a confirmed allergy to thisproduct or its formulation components.
Participants who smoked more than 5 cigarettes per day or the equivalent amount oftobacco within 3 months before screening.
Participants deemed unsuitable for the trial by the investigator due to otherfactors.
Study Design
Connect with a study center
The First Hospital of Jilin University
Changchun 2038180, Jilin 2036500 130031
ChinaActive - Recruiting

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