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| Name | Class |
|---|---|
| Beijing Siran Biotechnology Co.,Ltd. | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Participants | Experimental |
| |
| Chronic Hepatitis B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SA1211 injection | Drug | subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with AEs, SAEs and abnormal laboratory testings | AEs: Adverse Events. SAEs: Serious Adverse Events. | Approximate 24 weeks |
| 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 |
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Inclusion Criteria:
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:
- 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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feifei Zhao | Contact | +86 0512-65295926 | zhaofeifei@siranbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130031 | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| SA1211 injection placebo |
| Drug |
subcutaneous injection |
|
| 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 |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |