SA1211 Injection Phase 1 Study

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

SA1211 Injection Phase 1 Study (NCT07275918) is a Phase 1 interventional studying Chronic Hepatitis B, sponsored by Suzhou Siran Biotechnology Co.,Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Chronic Hepatitis B, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 80 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chronic Hepatitis B subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able to correctly understand and sign the willing to sign a consent form 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. Who Should NOT Join This Trial: 1. Participants with concurrent hepatitis C virus (HCV), human weakened immune system virus (HIV) or syphilis infection; or those previously diagnosed with hepatitis A, D, or E who have not been cured. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

SA1211 injection

subcutaneous injection

DRUG

SA1211 injection placebo

subcutaneous injection

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Hospital of Jilin University

Changchun, Jilin, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07275918), the sponsor (Suzhou Siran Biotechnology Co.,Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07275918 clinical trial studying?

Who can participate in NCT07275918?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07275918?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07275918. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07275918. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.