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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: SA1211 injection; Drug: SA1211 injection placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Feifei Zhao; Phone Number: +86 0512-65295926; Email: zhaofeifei@siranbio.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130031
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Junqi Niu; Email: junqiniu@aliyun.com
      • Contact: Yanhua Ding; Phone Number: +86 0431-85612345; Email: dingyanhua2003@126.com
      • Principal Investigator: Yanhua Ding, PhD.
      • Principal Investigator: Junqi Niu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Participants	Drug: SA1211 injection; subcutaneous injection; Drug: SA1211 injection placebo; subcutaneous injection
Experimental: Chronic Hepatitis B	Drug: SA1211 injection; subcutaneous injection; Drug: SA1211 injection placebo; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with AEs, SAEs and abnormal laboratory testings	AEs: Adverse Events. SAEs: Serious Adverse Events.	Approximate 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax: maximum concentration		Pre-dose, multiple time-points post dose until 48 hours
Tmax	Tmax: Time to Maximum Concentration	Pre-dose, multiple time-points post dose until 48 hours
AUC0-t	AUC0-t: Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable Concentration	Pre-dose, multiple time-points post dose until 48 hours
AUC0-inf	AUC0-inf: Area Under the Concentration-Time Curve from Time Zero to Infinity	Pre-dose, multiple time-points post dose until 48 hours
t1/2	t1/2: Half-life	Pre-dose, multiple time-points post dose until 48 hours
λz	λz: Terminal Elimination Rate Constant	Pre-dose, multiple time-points post dose until 48 hours
Vd/F	Vd/F: Volume of Distribution over Bioavailability	Pre-dose, multiple time-points post dose until 48 hours
CL/F	CL/F: Clearance over Bioavailability	Pre-dose, multiple time-points post dose until 48 hours
Css (Steady-State Concentration)		Pre-dose, multiple time-points post dose until 48 hours
DF (Degree of Fluctuation)		Pre-dose, multiple time-points post dose until 48 hours
The number of participants with chronic hepatitis B (CHB) who achieved hepatitis B surface antigen (HBsAg) clearance		Approximate 24 weeks
Maximum HBsAg Decline in CHB Participants Within 24 Weeks (log10)		Approximate 24 weeks
The number of CHB Participants with HBsAg Seroconversion at each assessment time Point within 24 weeks		Approximate 24 weeks
The number of CHB participants who achieved HBeAg seronegativity at each assessment time point within 24 weeks		Approximate 24 weeks
The number of participants with immunogenicity (i.e., anti-drug antibodies [ADAs])		Approximate 24 weeks
The change in QTcF relative to baseline and the change relative to placebo	Apply for healthy participants	Approximate 24 weeks

Collaborators and Investigators

• Sponsor: Suzhou Siran Biotechnology Co.,Ltd.
• Collaborators: Beijing Siran Biotechnology Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: CHB
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: SAHB101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No