SA1211 Injection Phase 1 Study

NCT07275918 | Recruiting Phase 1

• 1 other identifier: SAHB101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Keywords

CHB

Outcome Measures

Primary Outcomes (1)

• Number of participants with AEs, SAEs and abnormal laboratory testings

  AEs: Adverse Events. SAEs: Serious Adverse Events.

  Approximate 24 weeks

Secondary Outcomes (16)

• Cmax: maximum concentration

  Pre-dose, multiple time-points post dose until 48 hours

• Tmax

  Pre-dose, multiple time-points post dose until 48 hours

• AUC0-t

  Pre-dose, multiple time-points post dose until 48 hours

• AUC0-inf

  Pre-dose, multiple time-points post dose until 48 hours

• t1/2

  Pre-dose, multiple time-points post dose until 48 hours

Study Arms (2)

Healthy Participants

EXPERIMENTAL

Drug: SA1211 injection; Drug: SA1211 injection placebo

Chronic Hepatitis B

EXPERIMENTAL

Drug: SA1211 injection; Drug: SA1211 injection placebo

Interventions

SA1211 injection DRUG

subcutaneous injection

Chronic Hepatitis B; Healthy Participants

SA1211 injection placebo DRUG

subcutaneous injection

Chronic Hepatitis B; Healthy Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-off values).
• 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 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).
• 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.
• 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).
• For female participants of childbearing potential: must not be pregnant or lactating, and agree to use effective contraception during the study period.
• For male participants of childbearing potential: agree to use effective contraception during the study period to ensure effective contraception for their sexual partners.

You may not qualify if:

• 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.
• 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.
• Participants with severe mental illness or uncontrolled mental disorders, including but 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, or plan 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 this product or its formulation components.
• Participants who smoked more than 5 cigarettes per day or the equivalent amount of tobacco within 3 months before screening.
• Participants deemed unsuitable for the trial by the investigator due to other factors.

Sponsors & Collaborators

• Suzhou Siran Biotechnology Co.,Ltd.: lead
• Beijing Siran Biotechnology Co.,Ltd.: collaborator

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130031, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Feifei Zhao

CONTACT

+86 0512-65295926; zhaofeifei@siranbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 10, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)