ChiCTR2500113079 版本V1.0 版本创建时间2025/11/24 17:57:08 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500113079 

最近更新日期：

Date of Last Refreshed on：

2025-11-24 17:57:02 

注册时间：

Date of Registration：

2025-11-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价SA1211 注射液在健康志愿者以及慢性乙型肝炎参与者中的安全性、耐受性、 药代动力学以及初步疗效的随机、双盲、安慰剂对照I 期临床研究

Public 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 volunteers and participants with chronic hepatitis B

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价SA1211 注射液在健康志愿者以及慢性乙型肝炎参与者中的安全性、耐受性、 药代动力学以及初步疗效的随机、双盲、安慰剂对照I 期临床研究

Scientific 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 volunteers and participants with chronic hepatitis B

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

赵飞飞 

研究负责人：

丁艳华;牛俊奇 

Applicant：

Feifei Zhao 

Study leader：

Yanhua Ding;Junqi Niu 

申请注册联系人电话：

Applicant telephone：

+86 431 8561 2345

研究负责人电话：

Study leader's telephone：

+86 431 8561 2345

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

zhaofeifei@siranbio.com

研究负责人电子邮件：

Study leader's E-mail：

dingyanhua2003@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

苏州市工业园区新泽路1号生物医药产业园三期A区1号楼301单元

研究负责人通讯地址：

吉林省长春市朝阳区新民大街1号

Applicant address：

Unit 301, Building 1, Area A, Phase III, Biomedical Industrial Park, No. 1 Xinze Road, Suzhou Industrial Park

Study leader's address：

No. 1, Xinmin Street, Chaoyang District, Changchun City, Jilin Province

申请注册联系人邮政编码：

Applicant postcode：

102200

研究负责人邮政编码：

Study leader's postcode：

102200

申请人所在单位：

苏州时安生物技术有限公司

Applicant's institution：

Suzhou Siran Biotechnology Co.,Ltd.

研究负责人所在单位：

吉林大学第一医院

Affiliation of the Leader：

The First Hospital of Jilin University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

25Y337-001

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

吉林大学第一医院伦理委员会

Name of the ethic committee：

Ethics Committee of First Hospital of Jilin University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-09-17 00:00:00

伦理委员会联系人：

赵丽媛

Contact Name of the ethic committee：

Liyuan Zhao

伦理委员会联系地址：

吉林省长春市朝阳区新民大街1号

Contact Address of the ethic committee：

No. 1, Xinmin Street, Chaoyang District, Changchun City, Jilin Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 431 8878 2013

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

吉林大学第一医院

Primary sponsor：

The First Hospital of Jilin University

研究实施负责（组长）单位地址：

吉林省长春市朝阳区新民大街1号

Primary sponsor's address：

No. 1, Xinmin Street, Chaoyang District, Changchun City, Jilin Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京思原瑞安生物技术有限公司

具体地址：

北京市昌平区中关村生命科学园医疗园路9号院新生巢创新中心206

Institution
hospital：

Beijing Siran Biotechnology Co.,Ltd.

Address：

Room 206, Xinshengchao Innovation Center, Courtyard 9, Yiliaoyuan Road, Zhongguancun Life Science Park, Changping District, Beijing

经费或物资来源：

北京思原瑞安生物技术有限公司

Source(s) of funding：

Beijing Siran Biotechnology Co.,Ltd.

Target disease：

Chronic hepatitis B

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评估SA1211 注射液在健康参与者和CHB 参与者中的安全性和耐受性。  

Objectives of Study：

Evaluate the safety and tolerability of SA1211 Injection in healthy participants and CHB participants

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

以下入选标准适用于健康参与者（SAD部分）： 1. 能够正确理解并书面签署知情同意书； 2. 男性或女性参与者，年龄：18~55周岁（含临界值）； 3.体重指数（BMI）在18-28千克/平米（kg/m^2）范围内（含临界值），男性至少50kg，女性至少45kg； 4.筛选期，临床实验室检查（血常规、血生化、凝血功能、尿常规）、甲状腺功能、12导联心电图、腹部超声、胸部正位片等正常或异常无临床意义； 5.对于有生育能力的女性参与者：必须未怀孕、非哺乳期，并同意在研究期间高效避孕； 6.对于有生育能力的男性参与者：同意在研究期间高效避孕以确保性伴侣有效避孕。 以下入选标准适用于CHB参与者（MAD部分）： 1.能够正确理解并书面签署知情同意书； 2.男性或女性参与者，年龄：18~65周岁（含临界值）； 3.体重指数（BMI）在18-32千克/平米（kg/m^2）范围内（含临界值），男性至少50kg，女性至少45kg； 4.有记录的筛选前>= 6个月的乙型肝炎病毒感染：HBsAg阳性和/或HBV DNA阳性； 5.筛选期HBeAg阴性； 6.筛选前服用已批准的一线口服核苷（酸）类似物（NAs）稳定治疗>=6个月，且筛选前至少3个月稳定服用同一种NAs； 7. 筛选期HBV DNA<100 IU/mL； 8. 筛选期HBsAg水平<=1000 IU/mL（适用于MAD部分前3组， 150mg、300mg、450mg）； 9. 筛选期1000 IU/mL＜HBsAg水平<=3000 IU/mL（适用于MAD部分第4组，450mg）； 10.血清丙氨酸氨基转移酶（ALT）<=2倍参考值上限（ULN）； 11.肝瞬时弹性成像（FibroScan）结果显示肝脏硬度测定（LSM）水平小于12.4 kPa；或筛选前24个月内的肝组织活检显示Metavir评分为F0-F2； 12.对于有生育能力的女性参与者：必须未怀孕、非哺乳期，并同意在研究期间高效避孕； 13. 对于有生育能力的男性参与者：同意在研究期间高效避孕以确保性伴侣有效避孕。

Inclusion criteria

The following inclusion criteria apply to healthy participants (SAD section) : Be able to correctly understand and sign the informed consent form in person. 2. Male or female participants, aged 18 to 55 years old (including the critical value); 3. The body mass index (BMI) should be within the range of 18 to 28 kilograms per square meter (kg/m 2) (including the critical value), with a minimum of 50 kilograms for men and 45 kilograms for women. 4. During the screening period, normal or abnormal clinical laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine), thyroid function, 12-lead electrocardiogram, abdominal ultrasound, frontal chest X-ray, etc. have no clinical significance. 5. For fertile female participants: They must not be pregnant, not in the lactation period, and agree to efficient contraception during the study period; 6. For male participants with fertility: Agree to use efficient contraception during the study period to ensure that their sexual partners are effectively contraceptive. The following inclusion criteria apply to CHB participants (MAD section) : Be able to correctly understand and sign the informed consent form in person. 2. Male or female participants, aged 18 to 65 years old (inclusive of the critical value); 3. The body mass index (BMI) should be within the range of 18 to 32 kilograms per square meter (kg/m 2) (including the critical value), with a minimum of 50 kilograms for men and 45 kilograms for women. 4. Recorded hepatitis B virus infection at >= 6 months before screening: positive HBsAg and/or positive HBV DNA; 5. Negative HBeAg during the screening period; 6. Take the approved first-line oral nucleoside (acid) analogues (NAs) for stable treatment for ≥ 6 months before screening, and take the same NAs stably for at least 3 months before screening. 7. HBV DNA<100 IU/mL during the screening period; 8. The HBsAg level during the screening period should be less than or equal to 1000 IU/mL (applicable to the first three groups in the MAD section, 150mg, 300mg, and 450mg); 9. During the screening period, 1000 IU/mL < HBsAg level ≤ 3000 IU/mL (applicable to Group 4 of the MAD section, 450mg); 10. Serum alanine aminotransferase (ALT) ≤ 2 times the upper limit of the reference value (ULN); The results of transient liver elastography (FibroScan) showed that the liver stiffness measurement (LSM) level was less than 12.4 kPa. Or liver tissue biopsy within 24 months prior to screening shows a Metavir score of F0-F2; 12. For fertile female participants: They must not be pregnant, not in the lactation period, and agree to efficient contraception during the study period; 13. For male participants with fertility: Agree to use efficient contraception during the study period to ensure that their sexual partners are effectively contraceptive.

排除标准：

以下排除标准适用于健康参与者（SAD部分）： 1.合并乙肝病毒（HBV）、丙型肝炎病毒（HCV）、人类缺陷病毒（HIV）或梅毒者，或既往被诊断为甲肝、丁肝、戊肝，且未治愈者； 2.患有严重的疾病，包括但不限于神经系统、心血管系统、血液和淋巴系统、免疫系统、肾脏、肝脏、甲状腺、胃肠道、呼吸系统、代谢及骨骼等系统疾病及恶性肿瘤病史等，且经研究者判断可能影响其安全或影响研究结果者； 3. 患有严重的精神疾病或未控制的精神障碍，包括但不限于精神分裂症、双相情感障碍或抑郁症，研究者认为不适宜参加本临床试验者； 4.筛选时QT/QTc间期延长，如重复检查确认QTcF＞450 ms（Fridericia公式校正）； 5.参与者存在导致TdP的危险因素（如心力衰竭、低钾血症、低镁血症、长或存在有风险的束支阻滞等； 6. 筛选时，收缩压 >=140 mmHg 或舒张血>=90 mmHg，经研究者评估不适合参加本研究者； 7.筛选时，经Cockcroft-Gault 公式计算的肌酐清除率 （CLcr） <= 80 mL/min； 8.给药前1个月内接种过疫苗或减毒活疫苗，或计划在试验期间接种疫苗者； 9.筛选前6个月接受过大型手术，或者计划在研究期间进行手术者； 10.筛选前4周内有严重感染或外伤者； 11.给药前1个月内非生理性失血 ≥ 200 毫升（包括外伤、采血、献血），或计划在试验期间或给药后 30 天内献血者； 12.严重过敏体质（两种及以上药物及食物过敏），或明确对本品或其制剂成分过敏，由研究者决定不适合参加本研究者； 13.既往对皮下注射严重不耐受者（允许有轻微反应，如局部肿胀或发红）； 14.腹部皮肤异常，如纹身、活动性皮肤病（炎症、皮疹等），研究者认为可能干扰试验用药品皮下给药和/或观察注射部位反应； 15.试验用药品给药前 14 天内服用任何处方药、中草药、非处方药者； 16.参加其它药物临床试验的时间距本研究治疗在3个月内或在其它试验药物5个半衰期内，或筛选前6个月内参加过siRNA或者反义寡核苷酸药物临床试验（如果参与者在治疗前退出研究，即未接受研究药物治疗，可以入组本研究）； 17.筛选前 3 个月内每日吸烟量大于 5 支或等量烟草，或试验住院期间不能戒烟者； 18.筛选前 3 个月内每周饮酒量大于 14 单位（1 单位酒精≈360mL 啤酒或 45mL 酒精含量为 40%的烈酒或 150mL 葡萄酒），或给药前一天酒精呼气试验为阳性者（呼气酒精含量>0.0mg/100mL），或试验住院期间不能禁酒者； 19.现阶段/曾经是毒品吸食者/药物滥用者，或给药前一天尿液药物筛查呈阳性； 20.研究者认为有不适合参加试验的其他因素者。 以下排除标准适用于CHB参与者（MAD部分）： 1.筛选期实验室结果：血清甲胎蛋白（AFP）>70 μg/L；血清白蛋白<3.0 g/dL；国际标准化比值（INR）>1.5；血小板计数<90×10^9/L；血清总胆红素（TBIL）> 2×ULN（Gilbert综合征除外） ；血清肌酐>1.5×ULN或肌酐清除率<60 mL/min（按Cockcroft-Gault方程）；其它研究者认为可能对本研究的疗效和安全性数据解释产生干扰的任何有临床意义的实验室显著异常值； 2.合并丙型肝炎病毒（HCV）、人类缺陷病毒（HIV）或梅毒（抗体阳性且同时RPR阳性）者，或既往被诊断为甲肝、丁肝、戊肝，且未治愈者； 3.自身免疫性肝病（自身免疫性肝炎、原发性胆汁性胆管炎、原发性硬化性胆管炎）、遗传代谢性肝病（血色病、威尔逊氏病、家族性肝内胆汁淤积等）、药物性肝病以及中度以上的非酒精性脂肪性肝炎，研究者认为不适宜参加本临床试验者； 4.筛选前或筛选期存在肝脏失代偿史（如腹水、静脉曲张出血或肝性脑病）或肝硬化史； 5. 有器官移植史，既往或合并肝细胞癌（HCC）患者，或影像学提示肝脏恶性占位可能者； 6.免疫相关性疾病史（例如：原发性血小板减少症紫癜、系统性红斑狼疮、类风湿关节炎、自身免疫溶血性贫血、严重银屑病，或任何其他自身免疫性疾病）； 7.患有严重的疾病，包括但不限于神经系统、心血管系统、血液和淋巴系统、免疫系统、肾脏、肝脏、甲状腺、胃肠道、呼吸系统、代谢及骨骼等系统疾病及恶性肿瘤病史等，且经研究者判断可能影响其安全或影响研究结果者； 8.患有严重的精神疾病或未控制的精神障碍，包括但不限于精神分裂症、双相情感障碍或抑郁症，研究者认为不适宜参加本临床试验者； 9.筛选期12导联心电图检查结果异常且有临床意义，如重复检查确认QTcF>470ms（Fridericia公式校正）等，且研究者认为不适宜参加本临床试验者； 10.控制不良的高血压，收缩压 >=160 mmHg 或舒张血>=100 mmHg，经研究者评估不适合参加本试验者； 11. 给药前1个月内接种过疫苗或减毒活疫苗，或计划在试验期间接种疫苗者； 12.筛选前6个月接受过大型手术，或者计划在研究期间进行手术者； 13.筛选前4周内有严重感染或外伤者； 14. 给药前1个月内非生理性失血 ≥ 200 毫升（包括外伤、采血）者； 15.严重过敏体质（两种及以上药物及食物过敏），或明确对本品或其制剂成分过敏，由研究者决定不适合参加本研究者； 16.既往对皮下注射严重不耐受者（允许有轻微反应，如局部肿胀或发红）； 17.腹部皮肤异常，如纹身、活动性皮肤病（炎症、皮疹等），且研究者认为可能干扰试验用药品皮下给药和/或观察注射部位反应； 18.试验用药品给药前 14 天内使用处方药，稳定治疗给药除外：如治疗高血压/糖尿病的药物、治疗哮喘的吸入器或雾化器、激素替代疗法、抗组胺药和避孕疗法； 19. 筛选前6个月内使用免疫调节剂（长效聚乙二醇干扰素、胸腺素、白介素2、左旋咪唑、全身性皮质类固醇等）和/或细胞毒性药物者； 20.参加其它药物临床试验的时间距本研究治疗在1个月内或在其它试验药物5个半衰期内，或本研究用药前6个月内参加过siRNA或者反义寡核苷酸药物临床试验或抗HBV药物的临床试验（如果参与者在治疗前退出研究，即未接受研究药物治疗，可以入组本研究）； 21.筛选前 3 个月内每日吸烟量大于 5 支或等量烟草，或试验住院期间不能戒烟者； 22.筛选前 3 个月内每周饮酒量大于 14 单位（1 单位酒精≈360mL 啤酒或 45mL 酒精含量为 40%的烈酒或 150mL 葡萄酒），或给药前一天酒精呼气试验为阳性者（呼气酒精含量>0.0mg/100mL），或试验住院期间不能禁酒者； 23. 现阶段/曾经是毒品吸食者/药物滥用者，或首次给药前一天尿液药物筛查呈阳性； 24.研究者认为有不适合参加试验的其他因素者。

Exclusion criteria：

The following exclusion criteria apply to healthy participants (SAD section) : Those who have hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis, or have been previously diagnosed with hepatitis A, hepatitis D or hepatitis E and have not been cured; 2. Those who suffer from serious diseases, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidneys, liver, thyroid, gastrointestinal tract, respiratory system, metabolism and bones, as well as a history of malignant tumors, and who are determined by the researcher to possibly affect their safety or the research results; 3. Those who suffer from severe mental illness or uncontrolled mental disorders, including but not limited to schizophrenia, bipolar disorder or depression, and whom the researchers consider unsuitable to participate in this clinical trial; 4. The QT/QTc interval is prolonged during screening, such as repeated checks confirming that QTcF is greater than 450 ms (Fridericia formula correction); 5. Participants have risk factors for TdP (such as heart failure, hypokalemia, hypomagnesemia, long or risky bundle branch block, etc.); 6. At the time of screening, if the systolic blood pressure is greater than or equal to 140 mmHg or the diastolic blood pressure is greater than or equal to 90 mmHg, and the researcher assesses that the participant is not suitable for this study; 7. During screening, the creatinine clearance rate (CLcr) calculated by the Cockcroft-Gault formula was <= 80 mL/min; 8. Those who have received a vaccine or a live attenuated vaccine within one month before administration, or plan to receive a vaccine during the trial period; 9. Those who have undergone major surgery in the six months prior to screening or plan to undergo surgery during the study period; 10. Those who have had severe infections or external injuries within 4 weeks prior to screening; 11. Those who have lost no less than 200 milliliters of blood due to non-physiological reasons within one month before administration (including trauma, blood collection, and blood donation), or who plan to donate blood during the trial period or within 30 days after administration; 12. Those with severe allergic constitutions (allergic to two or more drugs and foods), or those who are clearly allergic to the ingredients of this product or its preparations, are determined by the researcher to be unsuitable to participate in this researcher. 13. Those who have a history of severe intolerance to subcutaneous injections (mild reactions such as local swelling or redness are allowed); 14. Abnormalities of abdominal skin, such as tattoos and active skin diseases (inflammation, rashes, etc.), which researchers believe may interfere with the subcutaneous administration of the investigational drug and/or the observation of the reaction at the injection site; 15. Those who have taken any prescription drugs, Chinese herbal medicines or over-the-counter drugs within 14 days before the administration of the investigational drug; 16. The time of participating in clinical trials of other drugs is within 3 months from the treatment of this study, or within 5 half-lives of other trial drugs, or within 6 months before screening for siRNA or antisense oligonucleotide drug clinical trials (if a participant withdraws from the study before treatment, that is, has not received treatment with the study drug, they can be enrolled in this study). 17. Those who smoked more than 5 cigarettes or an equivalent amount of tobacco per day within the 3 months prior to screening, or were unable to quit smoking during the trial hospitalization; 18. Those who consumed more than 14 units of alcohol per week within 3 months prior to screening (1 unit of alcohol ≈360 ml of beer or 45mL of 40% alcohol spirits or 150 ml of wine), or had a positive breath test for alcohol on the day before administration (breath alcohol content >0.0mg/100 ml) Or those who cannot abstain from alcohol during the trial hospitalization; 19. Currently or in the past being a drug user or abuser, or having tested positive in urine drug screening the day before administration; 20. Those who are considered by the researchers to have other factors that make them unsuitable for participating in the trial. The following exclusion criteria apply to CHB participants (MAD section) : Laboratory results during the screening period: Serum alpha-fetoprotein (AFP) >70 μg/L; Serum albumin <3.0 g/dL; International Normalized Ratio (INR) >1.5; Platelet count <90×10^9/L; Serum total bilirubin (TBIL) > 2×ULN (except for Gilbert syndrome); Serum creatinine >1.5×ULN or creatinine clearance rate <60 mL/min (according to the Cockcroft-Gault equation); Any laboratory-significant outliers of clinical significance that other researchers believe may interfere with the interpretation of the efficacy and safety data of this study; 2. Those who have hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis (with positive antibodies and positive RPR at the same time), or have been previously diagnosed with hepatitis A, hepatitis D, or hepatitis E and have not been cured; 3. Those with autoimmune liver diseases (autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis), genetic metabolic liver diseases (hemochromatosis, Wilson's disease, familial intrahepatic cholestasis, etc.), drug-induced liver diseases, and moderate to severe non-alcoholic steatohepatitis who are considered unsuitable to participate in this clinical trial by the researchers; 4. There is a history of liver decompensation (such as ascites, varicose vein bleeding or hepatic encephalopathy) or liver cirrhosis before or during the screening period; 5. Those with a history of organ transplantation, previous or combined hepatocellular carcinoma (HCC) patients, or those with imaging findings suggesting the possibility of malignant space-occupying lesions in the liver; 6. History of immune-related diseases (e.g., primary thrombocytopenia purpura, systemic lupus erythematosus, rheumatoid arthritis, autoimmune hemolytic anemia, severe psoriasis, or any other autoimmune disease); 7. Those who suffer from serious diseases, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidneys, liver, thyroid, gastrointestinal tract, respiratory system, metabolism and bones, as well as a history of malignant tumors, and who are determined by the researcher to possibly affect their safety or the research results; 8. Those who suffer from severe mental illness or uncontrolled mental disorders, including but not limited to schizophrenia, bipolar disorder or depression, and whom the researchers consider unsuitable to participate in this clinical trial; 9. Those whose 12-lead electrocardiogram (ECG) results during the screening period are abnormal and have clinical significance, such as repeated tests confirming QTcF>470ms (corrected by Fridericia formula), etc., and who are considered unsuitable to participate in this clinical trial by the researchers; 10. Individuals with poorly controlled hypertension, with systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg, who are assessed by the researchers as unsuitable to participate in this trial; 11. Those who have received a vaccine or a live attenuated vaccine within one month before administration, or plan to receive a vaccine during the trial period; 12. Those who have undergone major surgery in the six months prior to screening or plan to undergo surgery during the study period; 13. Those who have had severe infections or external injuries within 4 weeks prior to screening; 14. Those who have lost no less than 200 milliliters of blood due to non-physiological reasons within one month before administration (including trauma and blood collection); 15. Those with severe allergic constitutions (allergic to two or more drugs and foods), or those who are clearly allergic to the ingredients of this product or its preparations, are determined by the researcher to be unsuitable to participate in this researcher. 16. Those who have a history of severe intolerance to subcutaneous injections (mild reactions such as local swelling or redness are allowed); 17. Abnormal abdominal skin, such as tattoos, active skin diseases (inflammation, rash, etc.), and which the researchers believe may interfere with the subcutaneous administration of the investigational drug and/or the observation of the reaction at the injection site; 18. Prescription drugs used within 14 days before administration of the investigational drug, except for stable treatment administration: such as drugs for hypertension/diabetes, inhalers or nebulizers for asthma, hormone replacement therapy, antihistamines and contraceptive therapy; 19. Those who have used immunomodulators (long-acting peginterferon, thymosin, interleukin-2, levoimidazole, systemic corticosteroids, etc.) and/or cytotoxic drugs within 6 months prior to screening; 20. The time of participating in clinical trials of other drugs is within one month from the treatment of this study, or within five half-lives of other trial drugs, or within six months before the use of this study, the participant has participated in clinical trials of siRNA or antisense oligonucleotide drugs or anti-HBV drugs (if the participant withdraws from the study before treatment, that is, has not received treatment with the study drug) Can be enrolled in this study; 21. Those who smoked more than 5 cigarettes or an equivalent amount of tobacco per day within 3 months prior to screening, or were unable to quit smoking during the trial hospitalization; 22. Those who consumed more than 14 units of alcohol per week within 3 months prior to screening (1 unit of alcohol ≈360 ml of beer or 45mL of 40% alcohol or 150 ml of wine), or had a positive breath test for alcohol on the day before administration (breath alcohol content >0.0mg/100 ml) Or those who cannot abstain from alcohol during the trial hospitalization; 23. Currently/previously a drug user/abuser, or tested positive in urine drug screening the day before the first administration; 24. Those who are considered by the researchers to have other factors that make them unsuitable for participating in the trial.

研究实施时间：

Study execute time：

从 From 2025-11-18 00:00:00至 To 2027-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-11-24 00:00:00 至 To 2026-07-31 00:00:00  

干预措施：

Interventions：

组别：

健康参与者

样本量：

40

Group：

Healthy participants

Sample size：

干预措施：

5个剂量组爬坡，皮下注射

干预措施代码：

Intervention：

Five dose escalation groups, administered via subcutaneous injection

Intervention code：

组别：

慢性乙型肝炎参与者

样本量：

40

Group：

CHB participants

Sample size：

干预措施：

4组，前3个剂量组爬坡，第4组与第三组剂量相同，皮下注射

干预措施代码：

Intervention：

Four groups: the first three groups for dose escalation, and the fourth group at the same dose as the third group, with administration via subcutaneous injection

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 长春市 

市(区县)：

 长春市 

Country：

China 

Province：

Jilin 

City：

Chuangchun 

单位(医院)：

吉林大学第一医院 

单位级别：

三甲 

Institution
hospital：

First Hospital of Jilin University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

不良事件（AE）、严重不良事件（SAE）以及实验室异常发生的性质、严重程度以及发生率。

指标类型：

主要指标

Outcome：

Number of participants with AEs, SAEs and laboratory abnormalities.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PK 参数

指标类型：

次要指标

Outcome：

PK parameters

Type：

Secondary indicator

测量时间点：

用药前及用药后

测量方法：

Measure time point of outcome：

Pre-dose, multiple timepoints post dose

Measure method：

指标中文名：

抗病毒疗效评估

指标类型：

次要指标

Outcome：

Anti hepatitis B virus parameters

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

免疫药效学评估

指标类型：

次要指标

Outcome：

Immunopharmacodynamic parameters

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

免疫原性评估

指标类型：

次要指标

Outcome：

Immunogenicity parameters

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究采用区组随机设计，预先产生随机分配表。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study adopts a block randomization design, with a pre-generated random allocation schedule.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

双盲，对研究参与者和研究者设盲

Blinding：

Double-blind, blinding both the research participants and the researchers

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

CRF;EDC

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF;EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-11-24 17:57:02