ChiCTR2300072837 版本V1.1 版本创建时间2023/08/18 17:22:48 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：

 ChiCTR2300072837 

最近更新日期：

Date of Last Refreshed on：

 2023-06-26 16:37:03 

注册时间：

Date of Registration：

 2023-06-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

HT-102（BM012）注射液在健康受试者及e抗原阴性的慢性乙肝病毒感染患者中的安全性、耐受性、药代动力学及药效学特征：随机、双盲、安慰剂对照、单次及多次皮下注射给药、剂量递增的I期临床研究

Public title：

Safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-102 (BM012) injection in healthy subjects and e antigen-negative patients with chronic Hepatitis B virus infection: a randomized, double-blind, placebo-controlled Phase I trial of single and multiple subcutaneous administration with dose escalation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

HT-102（BM012）注射液在健康受试者及e抗原阴性的慢性乙肝病毒感染患者中的安全性、耐受性、药代动力学及药效学特征：随机、双盲、安慰剂对照、单次及多次皮下注射给药、剂量递增的I期临床研究

Scientific title：

Safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-102 (BM012) injection in healthy subjects and e antigen-negative patients with chronic Hepatitis B virus infection: a randomized, double-blind, placebo-controlled Phase I trial of single and multiple subcutaneous administration with dose escalation

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：

马彦琴 

研究负责人：

陆伦根 

Applicant：

Ma Yanqin 

Study leader：

Lu lungen 

申请注册联系人电话：

Applicant telephone：

 +86 138 5200 3844

研究负责人电话：

Study leader's
telephone：

+86 133 8161 6206

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：

 mayanqin@hepathera.com

研究负责人电子邮件：

Study leader's E-mail：

 lungenlu1965@163.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：

上海市浦东新区盛荣路367号2号楼3层

研究负责人通讯地址：

上海市-上海市-上海市虹口区武进路85号

Applicant address：

367 Shengrong Road, Pudong New District, Shanghai

Study leader's address：

85 Wujin Road, Hongkou District, Shanghai, China

申请注册联系人邮政编码：

Applicant postcode：

 200120

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

苏州星曜坤泽生物制药有限公司

Applicant's institution：

Suzhou HepaThera Biotech Co., Ltd.

研究负责人所在单位：

上海市第一人民医院

Affiliation of the Leader：

Shanghai General Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 院伦快[2023]175 号

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：

上海市第一人民医院人体试验伦理审查委员会

Name of the ethic committee：

Shanghai General Hospital Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-05-22 00:00:00

伦理委员会联系人：

耿雯倩

Contact Name of the ethic committee：

Geng Wenqian

伦理委员会联系地址：

中国-上海市-上海市-虹口区武进路86号

Contact Address of the ethic committee：

86 Wujin Road, Hongkou District, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 133 8161 6206

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 shiyilunli@sina.com

研究实施负责（组长）单位：

上海市第一人民医院

Primary sponsor：

Shanghai General Hospital

研究实施负责（组长）单位地址：

上海市-上海市-上海市虹口区武进路85号

Primary sponsor's address：

85 Wujin Road, Hongkou District, Shanghai, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

shanghai

City：

单位(医院)：

苏州星曜坤泽生物制药有限公司

具体地址：

浦东新区盛荣路367号2号楼3层

Institution
hospital：

Suzhou HepaThera Biotech Co., Ltd.

Address：

367 Shengrong Road, Pudong New District

经费或物资来源：

完全自筹

Source(s) of funding：

self-funded

研究疾病：

慢性乙型肝炎病毒感染  

Target disease：

chronic hepatitis B virus infection

研究疾病代码：

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：

研究健康受试者单次皮下注射HT-102（BM012）注射液和慢性乙肝病毒感染患者多次皮下注射HT-102（BM012）注射液的安全性及耐受性  

Objectives of Study：

To investigate the safety and tolerability of single subcutaneous injection of HT-102 (BM012) in healthy subjects and multiple subcutaneous injections of HT-102 (BM012) in patients with chronic hepatitis B virus infection

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1a入选标准： 1. 年龄：18~50周岁（包括边界值），男性或女性； 2. 体重指数（BMI，BMI=体重（kg）/身高2（m2））在18.0~28.0 kg/m2之间（包括边界值），并且： ? 男性体重350 kg; ? 女性体重345 kg. 3. 受试者为健康人，定义为：12导联心电图、血常规、尿常规、血生化、凝血常规检查正常或者异常无临床意义，且未合并显著心血管、呼吸、内分泌、肾脏、肝脏、消化道、皮肤、免疫、血液、神经、精神等系统疾病病史者。 4. 受试者承诺在试验期间及试验结束后3个月内无生育、捐献精子或卵子计划且自愿采取有效非药物避孕措施（非药物避孕措施包括完全禁欲、避孕套、避孕环、受试者结扎或伴侣结扎等）； 5. 试验前已经详细了解试验性质、意义、可能的获益，可能带来的不便和潜在的危险，并自愿参加本次临床试验，能与研究者良好沟通，遵从整个研究的要求，且签署了书面的知情同意书。 1b入选标准： 1. 18~65周岁慢性乙肝病毒感染患者（包括边界值），男性或女性； 2. 男性受试者体重≥ 50.0 kg，女性受试者体重≥ 45.0 kg，且体重指数（BMI）在18.0~30.0 kg/m2之间（包括边界值），（BMI=体重（kg）/身高2（m2））； 3. 慢性HBV感染，且HBeAg阴性； 4. 筛选前接受抗病毒治疗至少一年，且筛选前已接受核苷（酸）逆转录酶抑制剂稳定治疗≥3个月（核苷（酸）逆转录酶抑制剂限定为以下三种之一：恩替卡韦、富马酸替诺福韦酯、富马酸丙酚替诺福韦片），且筛选前3月内有检测报告提示HBV DNA＜2000 IU/mL； 5. HBsAg定量水平＜ 3000 IU/mL且＞200 IU/mL； 6. 受试者承诺在试验期间及试验结束后3个月内无生育、捐献精子或卵子计划且自愿采取有效非药物避孕措施（非药物避孕措施包括完全禁欲、避孕套、避孕环、伴侣结扎等）； 7. 试验前已经详细了解试验性质、意义、可能的获益，可能带来的不便和潜在的危险，并自愿参加本次临床试验，能与研究者良好沟通，遵从整个研究的要求，且签署了书面的知情同意书。

Inclusion criteria

1a Inclusion criteria: 1. Age: 18~50 years old (including the boundary value), male or female; 2. The body mass index (BMI, BMI= weight (kg)/height 2 (m2)) should be between 18.0 and 28.0 kg/m2 (including boundary values), and: ? men‘s weight 50 kg; ? women’s weight 45 kg . 3. The subjects were healthy people, defined as those with normal or abnormal 12-lead electrocardiogram, blood routine, urine routine, blood biochemistry, and coagulation routine, and without significant history of cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nervous, psychiatric and other diseases. 4. The subject undertakes to be childfree during the study period and for 3 months after the study, plan to donate sperm or eggs, and voluntarily use effective non-drug contraceptive methods (non-drug contraceptive methods include complete abstinence, condoms, contraceptive rings, subject ligation or partner ligation, etc.); 5. Before the trial, I have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial, and voluntarily participated in this clinical trial. I can communicate well with the researchers, comply with the requirements of the whole study, and have signed a written informed consent. 1b Inclusion criteria: 1. Patients aged 18-65 years with chronic hepatitis B virus infection (including boundary values), male or female; 2. Male subjects weighed ≥ 50.0 kg and female subjects weighed ≥ 45.0 kg, with body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 (including boundary values), (BMI= weight (kg)/height 2 (m2)); 3. Chronic HBV infection with negative HBeAg; 4. At least one year of antiviral therapy prior to screening, and ≥3 months of stable therapy with nucleoside (acid) reverse transcriptase inhibitors prior to screening (nucleoside (acid) reverse transcriptase inhibitors restricted to one of the following three types: Entecavir, Tenofovir fumarate, propofotenofovir fumarate tablets), and HBV DNA < 2000 IU/mL was reported within 3 months prior to screening; 5. Quantitative HBsAg level < 3000 IU/mL and > 200 IU/mL; 6. The subject undertakes to refrain from having children, plan to donate sperm or eggs, and voluntarily take effective non-drug contraceptive measures (non-drug contraceptive measures include complete abstinence, condoms, contraceptive rings, partner ligation, etc.) during and for 3 months after the trial; 7. Before the trial, I had a detailed understanding of the nature, significance, possible benefits, possible inconvenience and potential dangers of the trial, and voluntarily participated in the clinical trial. I could communicate well with the researchers, complied with the requirements of the whole study, and signed a written informed consent.

排除标准：

1a排除标准（健康受试者满足以下1项排除标准即排除）： 1. （问诊）活动性病理性出血史者（如消化性溃疡、颅内出血等），或有出血倾向者（如凝血功能障碍、反复牙龈出血等），或神经系统病史者（如头痛及癫痫等）； 2. 试验筛选期的HIV检查异常或/和乙型肝炎表面抗原、丙型肝炎抗体、梅毒螺旋体抗体呈阳性者； 3. （问诊）试验筛选前3个月内重大外伤或接受过重大手术者，或未从手术中康复，或接受了可能显著影响试验药物体内过程或安全性评价的手术者，或预计在试验过程中有手术计划者； 4. （问诊）在试验筛选前3个月内失血或献血 ≥ 200 mL，或计划在试验期间或试验结束后1个月内献血者； 5. （问诊）经研究者判断受试者有影响药物吸收、分布、代谢和排泄或可使依从性降低的疾病； 6. （问诊）筛选前4周内曾接种过疫苗者； 7. （问诊）有药物过敏史，或特定过敏史者（哮喘、荨麻疹、湿疹等），或过敏体质者（如对两种或以上药物、食物和花粉过敏）或已知对本药组分或类似物过敏者； 8. （问诊）试验筛选前2周内使用过或正在使用任何药物者，包括维生素及中草药等； 9. （问诊）筛选前一个月内平均每日吸烟量≥5支，或不同意在试验期间禁烟者；筛选前一个月内平均每周饮酒≥14单位酒精（1单位= 45 mL烈性酒，150 mL葡萄酒，350-360 mL啤酒），或不同意试验期间禁酒者； 10. （问诊）入住前2天内吸烟、饮酒或饮用含咖啡因的食物饮料者，酒精呼气检查阳性（或者＞0.0mg/100mL）者； 11. （问诊）有药物滥用史或吸毒史者或尿药筛查阳性者； 12. 腹部、大腿和上臂有大面积瘢痕、大面积纹身，且影响给药者需排除； 13. 血压异常（收缩压＞ 140 mmHg 或< 90 mm Hg，或舒张压 ＞ 90 mm Hg或< 50 mm Hg）； 14. 12导联心电图：心率> 100 bpm或< 50 bpm，QTcF > 450ms，或者异常且研究者认为有临床意义； 15. 腹部超声结果经临床医生判断为异常有临床意义者； 16. 筛选期的实验室检查（血常规、尿常规、血生化、凝血功能等）结果经临床医生判断为异常有临床意义者； 17. （问诊）试验筛选前3个月内使用过其他临床试验药物或医疗器械，或计划在本研究期间参加其他临床试验者； 18. （问诊）妊娠期或哺乳期女性或妊娠试验呈阳性者； 19. （问诊）不能耐受皮下注射，或有晕针晕血史，或不适合进行静脉采血者； 20. （问诊）受试者可能因为其他原因而不能完成本研究试验，或研究者认为不适宜参加本研究试验者。 1b排除标准 1. （问诊）既往临床诊断为肝硬化的患者；或既往具有肝功能失代偿表现或疾病史，包括但不限于：食管胃底静脉曲张破裂出血、腹水、肝性脑病等； 2. （问诊）酒精性肝病，自身免疫性肝病，遗传代谢性肝病等其他肝脏疾病史等； 3. 肝癌史或怀疑存在肝癌风险：腹部超声或其他影像学（MRI或CT）存在肝癌可能和/或甲胎蛋白≥50μg/L； 4. 合并获得性免疫缺陷综合征（AIDS）的患者，或传染病筛查（人类免疫缺陷病毒抗体、梅毒螺旋体抗体、甲肝抗体、丙型肝炎病毒抗体、丁肝抗体、戊肝抗体）阳性且研究者认为有临床意义者； 5. （问诊）活动性病理性出血（如消化性溃疡、颅内出血）或消化性溃疡史、颅内出血史者； 6. （问诊）试验筛选前3个月内重大外伤或接受过重大手术者，或未从手术中康复，或接受了可能显著影响试验药物体内过程或安全性评价的手术者，或预计在试验过程中有手术计划者； 7. （问诊）经研究者判断受试者有影响药物吸收、分布、代谢和排泄或可使依从性降低的疾病； 8. （问诊）试验筛选前3个月内使用其他临床试验药物或医疗器械，或计划在本研究期间参加其他临床试验者； 9. （问诊）筛选前3个月内失血≥ 200 mL； 10. （问诊）筛选前一周内出现具有显著临床意义的急性感染，如发热或上呼吸道感染； 11. （问诊）筛选前4周内曾接种过疫苗； 12. （问诊）有药物过敏史，或特定过敏史者（哮喘、荨麻疹、湿疹等），或过敏体质者（如对两种或以上药物、食物和花粉过敏）或可疑对本药组分或类似物过敏者； 13. （问诊）筛选前1年内使用α-干扰素类药物或筛选前1个月内使用免疫抑制剂或其他免疫调节剂类药物者； 14. （问诊）筛选前一个月内平均每日吸烟量≥ 5支；筛选前一个月内平均每周饮酒≥ 14单位酒精（1单位 = 45 mL烈性酒，150 mL葡萄酒，350-360 mL 啤酒），或不同意在试验期间禁烟或禁酒者； 15. （问诊）随机前2天内吸烟、饮酒、或饮用含咖啡因的食物或饮料者，或酒精呼气检测阳性（或者＞0.0 mg/100 mL）者； 16. （问诊）有药物滥用史或吸毒史者或尿药筛查阳性者； 17. （问诊）腹部、大腿和上臂有大面积瘢痕、大面积纹身，且影响给药者需排除； 18. 控制不佳的血压异常（收缩压＞ 160 mmHg 或 < 90 mm Hg，或舒张压＞ 100 mm Hg 或 < 50 mm Hg）； 19. 12导联心电图：心率 > 100bpm 或 < 50 bpm，QTcF > 450ms，或者异常且研究者认为有临床意义； 20. 腹部超声提示异常且研究者认为有临床意义：比如多囊肾、独肾等； 21. 筛选期的实验室检查（血常规、尿常规、血生化、凝血功能等）等结果经临床医生判断为异常有临床意义者，比如： a. 血红蛋白（Hb）< 90g /L； b. 血小板（PLT）< 80 × 109/L； c. 尿蛋白≥ ++ ； d. 血肌酐（Cr）≥ 2 × ULN； e. 丙氨酸氨基转移酶（ALT）和/或天门冬氨酸氨基转移酶（AST）≥ 1.5 × ULN； f. 直接胆红素 > 2倍正常值上限； g. 血清白蛋白< 35 g/L； h. 糖化血红蛋白> 7 %； i. 凝血酶原时间（PT）延长> 3 s，或凝血酶原时间国际标准化比值（INR）> 1.5，或纤维蛋白原（FIB）异常有临床意义； 22. （问诊）妊娠期或哺乳期女性或妊娠试验呈阳性者； 23. （问诊）不能耐受皮下注射，或有晕针晕血史者，或不适合进行静脉采血者； 24. （问诊）受试者可能因为其他原因而不能完成本研究试验，或研究者认为不适宜参加本研究试验者。

Exclusion criteria：

1a Exclusion Criteria (Healthy subjects who meet 1 of the following exclusion criteria are excluded) : 1. (for consultation) patients with a history of active pathological bleeding (such as peptic ulcer, intracranial bleeding, etc.), or with bleeding tendency (such as coagulopathy, recurrent gingival bleeding, etc.), or with a history of nervous system (such as headache and epilepsy, etc.); 2. Patients with abnormal HIV test or/positive hepatitis B surface antigen, hepatitis C antibody and treponema pallidum antibody during the screening period; 3. (Consultation) Patients who suffered major injuries or underwent major surgery within 3 months prior to screening, or who did not recover from surgery, or who underwent surgery that may significantly affect the in vivo course or safety evaluation of the test drug, or who are expected to have surgery plans during the course of the trial; 4. (Consultation) Blood loss or blood donation ≥ 200 mL within 3 months prior to the screening of the test, or plan to donate blood during the trial or within 1 month after the end of the trial; 5. (Consultation) The subject is judged by the investigator to have a medical condition that affects drug absorption, distribution, metabolism, and excretion or that may reduce compliance; 6. (consultation) persons who have been vaccinated within 4 weeks prior to screening; 7. (Consultation) Patients with a history of drug allergy, or a history of specific allergy (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergy to two or more drugs, food and pollen), or known allergy to the components or analogens of the drug; 8. Those who have used or are using any drugs, including vitamins and Chinese herbs, in the 2 weeks prior to the screening test; 9. (for consultation) the average daily smoking amount in the month before screening is not less than 5, or do not agree to ban smoking during the test period; Who consumed an average of at least 14 units of alcohol per week (1 unit = 45 mL liquor, 150 mL wine, 350-360 mL beer) in the month prior to screening, or did not agree to abstain from alcohol during the test period; 10. (Consultation) Patients who have smoked, consumed alcohol or caffeinated food and beverages within 2 days prior to check-in and have a positive breath test for alcohol (or > 0.0mg/100mL); 11. (Consultation) persons with a history of substance abuse or drug use or those who have tested positive for urine drugs; 12. Large scar or tattoo on abdomen, thigh and upper arm, which affects drug administration, should be excluded; 13. Abnormal blood pressure (systolic > 140 mmHg or < 90 mmHg, diastolic > 90 mmHg or < 50 mmHg); 14. 12-lead ECG: Heart rate > 100 bpm or < 50 bpm, QTcF > 450ms, or abnormal and considered clinically significant by the investigator; 15. The results of abdominal ultrasound judged by clinicians as abnormal and clinically significant; 16. The results of laboratory examinations (blood routine, urine routine, blood biochemistry, coagulation function, etc.) during the screening period are judged by clinicians as abnormal and clinically significant; 17. (Consultation) Patients who have used other investigational drugs or medical devices in the 3 months prior to the trial screening, or plan to participate in other clinical trials during the study period; 18. (Consultation) women who are pregnant or breastfeeding or who have tested positive for pregnancy; 19. (consultation) Patients who cannot tolerate subcutaneous injection, or have a history of fainting needles and fainting blood, or are not suitable for intravenous blood collection; 20. (Interview) Subjects may not be able to complete the study for other reasons, or may not be considered suitable to participate in the study by the investigator. 1b Exclusion criteria 1. (Consultation) patients with previous clinical diagnosis of cirrhosis; Or a history of liver decompensation, including but not limited to: esophageal and gastric varices rupture, hemorrhage, ascites, hepatic encephalopathy, etc.; 2. (consult) alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease and other liver disease history; 3. History or suspected risk of liver cancer: Possible presence of liver cancer on abdominal ultrasound or other imaging (MRI or CT) and/or alpha-fetoprotein ≥50μg/L; 4. Patients with acquired immune deficiency syndrome (AIDS), or infectious disease screening (human immunodeficiency virus antibody, treponema pallidum antibody, hepatitis A antibody, hepatitis C virus antibody, hepatitis D antibody, hepatitis E antibody) positive and considered clinical significance by researchers; 5. (consultation) patients with active pathological bleeding (such as peptic ulcer, intracranial hemorrhage) or history of peptic ulcer or intracranial hemorrhage; 6. (Consultation) Patients who suffered major injuries or underwent major surgery within 3 months prior to screening, or who did not recover from surgery, or who underwent surgery that may significantly affect the in vivo course or safety evaluation of the drug under study, or who are expected to have a surgical plan during the course of the trial; 7. (Consultation) The subject is judged by the investigator to have a medical condition that affects drug absorption, distribution, metabolism, and excretion or that may reduce compliance; 8. (Consultation) Use of other investigational drugs or medical devices within 3 months prior to screening, or plan to participate in other clinical trials during the study period; 9. Blood loss ≥ 200 mL within 3 months prior to screening (consultation); 10. Acute infection of clinically significant significance, such as fever or upper respiratory tract infection, occurs within one week prior to screening; 11. Vaccination within 4 weeks prior to screening (consultation); 12. (Consultation) Patients with a history of drug allergy, or a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergy to two or more drugs, food and pollen), or suspected allergy to the components or analogens of the drug; 13. (Consultation) use of alpha-interferon drugs within 1 year prior to screening or use of immunosuppressants or other immunomodulators within 1 month prior to screening; 14. (consultation) The average daily smoking amount within one month before screening ≥ 5 pieces; Who consumed at least 14 units of alcohol per week (1 unit = 45 mL liquor, 150 mL wine, 350-360 mL beer) in the month prior to screening, or did not agree to ban smoking or alcohol during the trial period; 15. (Consultation) anyone who has smoked, consumed alcohol, or consumed caffeinated food or beverages, or had a positive breath test for alcohol (or > 0.0 mg/100 mL) in the 2 days prior to randomization; 16. (Consultation) persons with a history of substance abuse or drug use or those who have tested positive for urine drugs; 17. (Consultation) large scar or tattoo on abdomen, thigh and upper arm, which affects drug administration, should be excluded; 18. Poorly controlled abnormal blood pressure (systolic > 160 mmHg or < 90 mmHg, or diastolic > 100 mmHg or < 50 mmHg); 19. 12-lead ECG: Heart rate > 100bpm or < 50bpm, QTcF > 450ms, or abnormal and considered clinically significant by the investigator; 20. Abdominal ultrasound indicated abnormalities that researchers considered clinical significance: such as polycystic kidney, single kidney, etc.; 21. Laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, etc.) during the screening period are judged by clinicians as abnormal and clinically significant, such as: a. Hemoglobin (Hb) < 90g /L; b. Platelet (PLT) < 80 × 109/L; c. urinary protein ≥ ++; d. Serum creatinine (Cr) ≥ 2 × ULN; e. alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 1.5 × ULN; f. Direct bilirubin > 2 times the upper limit of normal; g. Serum albumin < 35 g/L; h. glycosylated hemoglobin > 7%; i. prothrombin time (PT) elongation > 3 s, or INR > 1.5, or fibrinogen (FIB) abnormality is clinically significant; 22. (Consultation) women who are pregnant or breastfeeding or who have tested positive for pregnancy; 23. (Consultation) Patients who cannot tolerate subcutaneous injection, or who have a history of fainting needles and fainting blood, or who are not suitable for venous blood collection; 24. (Interview) The subject may be unable to complete the study for other reasons, or may not be considered suitable to participate in the study by the investigator.

研究实施时间：

Study execute time：

从 From 2023-06-05 00:00:00至 To 2024-08-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-06-12 00:00:00 至 To 2024-02-01 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 42

Group：

experimental group

Sample size：

干预措施：

HT-102（BM012）注射液

干预措施代码：

Intervention：

HT-102(BM012)injection

Intervention code：

组别：

安慰剂组

样本量：

 14

Group：

placebo group

Sample size：

干预措施：

HT-102（BM012）安慰剂

干预措施代码：

Intervention：

HT-102(BM012)placebo

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China

Province：

shanghai

City：

单位(医院)：

 上海市第一人民医院 

单位级别：

 三甲 

Institution
hospital：

Shanghai General Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

  

Country：

China

Province：

shandong

City：

单位(医院)：

 山东省公共卫生临床中心  

单位级别：

 三甲 

Institution
hospital：

Public Health Clinical Center of Shandong Province

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

  

Country：

China

Province：

henan

City：

单位(医院)：

 洛阳市中心医院 

单位级别：

 三甲 

Institution
hospital：

Luoyang Central Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

  

Country：

China

Province：

fujian

City：

单位(医院)：

 福建医科大学孟超肝胆医院 

单位级别：

 三甲 

Institution
hospital：

Meng Chao Hepatobiliary Hospital of Fujian Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

china

Province：

guangdong

City：

单位(医院)：

 清远市人民医院 

单位级别：

 三甲 

Institution
hospital：

Qingyuan People's Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

  

Country：

China

Province：

henan

City：

单位(医院)：

 郑州市第六人民医院 

单位级别：

 三甲 

Institution
hospital：

The Sixth People's Hospital of Zhengzhou

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

  

Country：

China

Province：

fujian

City：

单位(医院)：

 厦门市中医院 

单位级别：

 三甲 

Institution
hospital：

Xiamen Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

  

Country：

China

Province：

zhejiang

City：

单位(医院)：

 浙江大学医学院附属第一医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Zhejiang University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

不良事件

指标类型：

主要指标

Outcome：

Adverse events

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

主要终点：安全性评价指标（包括Ia和Ib阶段）： 观察所有受试者在临床研究期间发生的任何不良事件，包括临床症状及生命体征异常、实验室检查中出现的异常。

指标类型：

主要指标

Outcome：

Primary endpoint: Safety assessment measures (including Phase Ia and Ib) : All subjects were observed for any adverse events that occurred during the clinical study, including abnormalities in clinical symptoms and vital signs, and abnormalities in laboratory tests

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

1）血清中HT-102（BM012）的浓度经时变化；药代动力学参数；

指标类型：

次要指标

Outcome：

1) The concentration of HT-102 (BM012) in serum changed over time; Pharmacokinetic 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：

不同剂量组给药后HBV DNA、HBsAg、HBV RNA、HBcrAg、HBcAb定量较基线的变化（慢性乙肝病毒感染受试者）

指标类型：

次要指标

Outcome：

Changes of HBV DNA, HBsAg, HBV RNA, HBcrAg, HBcAb quantification from baseline in different dose groups (Subjects with chronic Hepatitis B virus infection)

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：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

本试验按照剂量递增进行随机化，采用区组随机的方法，以SAS软件（9.4或以上版本）产生随机表，采用临床试验中央随机化系统（IRT）分配随机号

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

This trial was randomized according to dose increment. Block randomization was used. SAS software (version 9.4 or above) was used to generate randomization tables, and the Central Randomization System of Clinical Trials (IRT) was used to assign randomization numbers

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：

无

Blinding：

N/A

是否共享原始数据：

IPD sharing

否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)：

N/A

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：

EDC

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

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2023-06-26 16:36:54