SA1211 injection safety and dosing in people with chronic hepatitis B and healthy volunteers

A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SA1211 Injection in Healthy Participants and Participants With Chronic Hepatitis B

This trial will test whether one or multiple under-the-skin injections of SA1211 are safe, trigger immune responses, and show early signs of benefit in adults with chronic hepatitis B and in healthy volunteers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Suzhou Siran Biotechnology Co.,Ltd. (Industry-sponsored)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT07275918 on ClinicalTrials.gov

What this trial studies

This Phase 1, first-in-human trial has two parts: a single-dose part in healthy volunteers (Part A) and a multiple-dose part in adults with chronic hepatitis B (Part B). Participants receive subcutaneous injections of SA1211 or placebo and undergo safety monitoring, laboratory tests, immunogenicity assays, and pharmacokinetic blood sampling. The study will characterize tolerability, immune responses, and drug levels over time and look for preliminary antiviral or clinical signals in the CHB group. Findings will guide dosing and design of later-stage trials.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic hepatitis B who meet the trial's age (18–65), BMI (18–32 kg/m²), and screening lab criteria, as well as healthy volunteers aged 18–55 for the single-dose part.

Not a fit: People with advanced or decompensated liver disease, unstable medical conditions, or who do not meet the age, BMI, or screening laboratory criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, SA1211 could help people with chronic hepatitis B by boosting immune responses and reducing viral activity.

How similar studies have performed: Other early-phase immune-based approaches for chronic hepatitis B have shown immunogenicity in small trials but only occasional antiviral control, so this approach remains experimental.

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.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Feifei Zhao

Conditions Chronic Hepatitis B; CHB