| NCT ID | NCT07275918 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Suzhou Siran Biotechnology Co.,Ltd. |
| Condition | Chronic Hepatitis B |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-11-25 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of SA1211 Injection in healthy volunteers (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in participants with chronic hepatitis B (CHB). The main questions it aims to answer are: What are the safety, tolerability, immunogenicity and PK characteristics of a single subcutaneous injection of SA1211 Injection in healthy volunteers (Part A)? What are the safety, tolerability, immunogenicity and PK characteristics of multiple subcutaneous injections of SA1211 Injection in participants with CHB (Part B)? What is the preliminary efficacy of SA1211 Injection in participants with CHB (Part B)? Participants will: * Part A (healthy volunteers): Receive a single subcutaneous injection of SA1211 Injection or placebo and complete relevant safety, tolerability and PK monitoring as required. * Part B (participants with CHB): Receive multiple subcutaneous injections of SA1211 Injection or placebo and complete relevant safety, tolerability, PK monitoring and preliminary efficacy assessment as required.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07275918 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07275918 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07275918 currently recruiting?
Yes, NCT07275918 is actively recruiting participants. Contact the research team at zhaofeifei@siranbio.com for enrollment information.
Where is the NCT07275918 trial being conducted?
This trial is being conducted at Changchun, China.
Who is sponsoring the NCT07275918 clinical trial?
NCT07275918 is sponsored by Suzhou Siran Biotechnology Co.,Ltd.. The trial plans to enroll 80 participants.