Actively Recruiting
SA1211 Injection Phase 1 Study
Led by Suzhou Siran Biotechnology Co.,Ltd. · Updated on 2025-12-10
80
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
Sponsors
S
Suzhou Siran Biotechnology Co.,Ltd.
Lead Sponsor
B
Beijing Siran Biotechnology Co.,Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SA1211 Injection Phase 1 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign the informed consent form.
- Male or female participants.
- Healthy participants aged 18-55 years; participants with chronic hepatitis B aged 18-65 years.
- Body Mass Index (BMI) 18-28 kg/m² for healthy participants; 18-32 kg/m² for participants with chronic hepatitis B.
- Normal or clinically insignificant abnormal results in lab tests, ECG, abdominal ultrasound, and chest X-ray during screening.
- For chronic hepatitis B participants: documented infection for at least 6 months with positive hepatitis B surface antigen or DNA.
- Female participants of childbearing potential must not be pregnant or lactating and agree to use effective contraception during the study.
- Male participants of childbearing potential must agree to use effective contraception during the study.
You will not qualify if you...
- Infection with hepatitis C virus, HIV, or syphilis; or uncured hepatitis A, D, or E.
- Severe diseases affecting nervous, cardiovascular, blood, immune, kidney, liver, thyroid, digestive, respiratory, metabolic, or skeletal systems, or history of cancer.
- Severe mental illness or uncontrolled mental disorders like schizophrenia, bipolar disorder, or depression.
- Blood pressure at screening with systolic ≥140 mmHg or diastolic ≥90 mmHg deemed unsuitable by investigator.
- Major surgery within 6 months before screening or planned surgery during the study.
- Severe infection or trauma within 4 weeks before screening.
- Severe allergies or known allergy to the study product or its components.
- Smoking more than 5 cigarettes per day or equivalent tobacco within 3 months before screening.
- Any other factors making the participant unsuitable as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130031
Actively Recruiting
Research Team
F
Feifei Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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