Chronic Hepatitis BPhase 1NCT07275918
SA1211 Injection Phase 1 Study
A Phase 1 study testing SA1211 injection in people with Chronic Hepatitis B, run by Suzhou Siran Biotechnology Co.,Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- SA1211 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2025to 30 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130031
Yanhua Ding, +86 0431-85612345, dingyanhua2003@126.com
Junqi Niu, junqiniu@aliyun.com
About this study
Official title: 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)?
Read more
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
- Being tested
- SA1211 injection, SA1211 injection placebo
- Keywords
- CHB
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA1211 injectionDrug
subcutaneous injection
SA1211 injection placeboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | Not described Receives: Drug: SA1211 injection; Drug: SA1211 injection placebo |
| Chronic Hepatitis B | Experimental | Not described Receives: Drug: SA1211 injection; Drug: SA1211 injection placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with AEs, SAEs and abnormal laboratory testings
AEs: Adverse Events. SAEs: Serious Adverse Events.
Measured: Approximate 24 weeks
Secondary outcomes (16)
Cmax: maximum concentration
Measured: Pre-dose, multiple time-points post dose until 48 hours
Tmax
Tmax: Time to Maximum Concentration
Measured: 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
Measured: 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
Measured: Pre-dose, multiple time-points post dose until 48 hours
t1/2
t1/2: Half-life
Measured: Pre-dose, multiple time-points post dose until 48 hours
λz
λz: Terminal Elimination Rate Constant
Measured: Pre-dose, multiple time-points post dose until 48 hours
Vd/F
Vd/F: Volume of Distribution over Bioavailability
Measured: Pre-dose, multiple time-points post dose until 48 hours
CL/F
CL/F: Clearance over Bioavailability
Measured: Pre-dose, multiple time-points post dose until 48 hours
Css (Steady-State Concentration)
Measured: Pre-dose, multiple time-points post dose until 48 hours
DF (Degree of Fluctuation)
Measured: 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
Measured: Approximate 24 weeks
Maximum HBsAg Decline in CHB Participants Within 24 Weeks (log10)
Measured: Approximate 24 weeks
The number of CHB Participants with HBsAg Seroconversion at each assessment time Point within 24 weeks
Measured: Approximate 24 weeks
The number of CHB participants who achieved HBeAg seronegativity at each assessment time point within 24 weeks
Measured: Approximate 24 weeks
The number of participants with immunogenicity (i.e., anti-drug antibodies [ADAs])
Measured: Approximate 24 weeks
The change in QTcF relative to baseline and the change relative to placebo
Apply for healthy participants
Measured: Approximate 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start25 Nov 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Siran Biotechnology Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Siran Biotechnology Co.,Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275918
- Sponsor's protocol ID
- SAHB101
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07275918
- Acronym / sponsor ID
- SAHB101
- Conditions
- Chronic Hepatitis B
- Keywords
- CHB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Suzhou Siran Biotechnology Co.,Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Siran Biotechnology Co.,Ltd.
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Drug: SA1211 injection, Drug: SA1211 injection placebo |
| Chronic Hepatitis B | Experimental | Drug: SA1211 injection, Drug: SA1211 injection placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to correctly understand and sign the informed consent form in writing.
- Male or female participants.
- Body Mass Index (BMI) meets the following requirements.
- During the screening period, the results of the following examinations are either normal or abnormal but not clinically insignificant:
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SA1211 injectionsubcutaneous injection | Drug | Chronic Hepatitis B, Healthy Participants |
| SA1211 injection placebosubcutaneous injection | Drug | Chronic Hepatitis B, Healthy Participants |
Primary outcome
Number of participants with AEs, SAEs and abnormal laboratory testings
Time frame: Approximate 24 weeks
AEs: Adverse Events. SAEs: Serious Adverse Events.
16 secondary outcomes
Cmax: maximum concentration
Time frame: Pre-dose, multiple time-points post dose until 48 hours
Tmax
Time frame: Pre-dose, multiple time-points post dose until 48 hours
AUC0-t
Time frame: Pre-dose, multiple time-points post dose until 48 hours
AUC0-inf
Time frame: Pre-dose, multiple time-points post dose until 48 hours
t1/2
Time frame: Pre-dose, multiple time-points post dose until 48 hours
λz
Time frame: Pre-dose, multiple time-points post dose until 48 hours
Vd/F
Time frame: Pre-dose, multiple time-points post dose until 48 hours
CL/F
Time frame: Pre-dose, multiple time-points post dose until 48 hours
Css (Steady-State Concentration)
Time frame: Pre-dose, multiple time-points post dose until 48 hours
DF (Degree of Fluctuation)
Time frame: 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
Time frame: Approximate 24 weeks
Maximum HBsAg Decline in CHB Participants Within 24 Weeks (log10)
Time frame: Approximate 24 weeks
The number of CHB Participants with HBsAg Seroconversion at each assessment time Point within 24 weeks
Time frame: Approximate 24 weeks
The number of CHB participants who achieved HBeAg seronegativity at each assessment time point within 24 weeks
Time frame: Approximate 24 weeks
The number of participants with immunogenicity (i.e., anti-drug antibodies [ADAs])
Time frame: Approximate 24 weeks
The change in QTcF relative to baseline and the change relative to placebo
Time frame: Approximate 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SA1211 injection in people with Chronic Hepatitis B, run by Suzhou Siran Biotechnology Co.,Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feifei Zhao (+86 0512-65295926, zhaofeifei@siranbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with AEs, SAEs and abnormal laboratory testings (time frame: Approximate 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.