ChiCTR2500114949 版本V1.0 版本创建时间2025/12/19 11:38:34 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：

ChiCTR2500114949 

最近更新日期：

Date of Last Refreshed on：

2025-12-19 11:38:11 

注册时间：

Date of Registration：

2025-12-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价EPI-001T注射液治疗冠状动脉粥样硬化性血管疾病（ASCVD）或其ASCVD风险等效者的耐受性、安全性剂量递增及剂量扩展的研究

Public title：

A study to evaluate the tolerance, safety, dose escalation and dose expansion of EPI-001T injection in the treatment of atherosclerotic cardiovascular disease (ASCVD) or its ASCVD risk equivalents

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价EPI-001T注射液治疗冠状动脉粥样硬化性血管疾病（ASCVD）或其ASCVD风险等效者的耐受性、安全性、药代动力学特征和初步有效性的开放、单臂、剂量递增及剂量扩展的研究者发起研究（IIT）

Scientific title：

An open-label, single-arm, dose-escalation and dose-expansion investigator-initiated trial (IIT) to evaluate the tolerability, safety, pharmacokinetic characteristics and preliminary efficacy of EPI-001T injection in the treatment of atherosclerotic cardiovascular disease (ASCVD) or its ASCVD risk equivalents.

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：

王晓林 

研究负责人：

夏强 

Applicant：

Xiaolin Wang 

Study leader：

Xia Qiang 

申请注册联系人电话：

Applicant telephone：

+86 13825619560

研究负责人电话：

Study leader's telephone：

+86 21 58752345

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：

xiaolin.wang@epigenictx.com

研究负责人电子邮件：

Study leader's E-mail：

xiaqiang@medmail.com.cn

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：

上海浦东新区自由贸易试验区巴圣路160号4幢1单元6楼

研究负责人通讯地址：

上海市浦建路160号

Applicant address：

6th Floor, Unit 1, Building 4, No. 160, Bashi Road, Pudong New Area, Shanghai Free Trade Zone

Study leader's address：

No.160, Pujian Road, Shanghai, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

益杰立科（上海）生物科技有限公司

Applicant's institution：

Epigenic (Shanghai) Biotechnology Co., Ltd.

研究负责人所在单位：

上海交通大学医学院附属仁济医院

Affiliation of the Leader：

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

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：

LY2025-347-B

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：

上海交通大学医学院附属仁济医院研究伦理分委会B组

Name of the ethic committee：

Shanghai Jiaotong University School of Medicine Renji Hospital Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-05 00:00:00

伦理委员会联系人：

陆麒

Contact Name of the ethic committee：

Lu Qi

伦理委员会联系地址：

上海市浦建路160号

Contact Address of the ethic committee：

No.160, Pujian Road, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 5875 2345

伦理委员会联系人邮箱：

Contact email of the ethic committee：

rjluqi@hotmail.com

研究实施负责（组长）单位：

上海交通大学医学院附属仁济医院

Primary sponsor：

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

研究实施负责（组长）单位地址：

上海市浦建路160号

Primary sponsor's address：

No.160, Pujian Road, 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

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海交通大学医学院附属仁济医院

具体地址：

上海市浦建路160号

Institution
hospital：

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

Address：

No.160, Pujian Road, Shanghai, China

经费或物资来源：

益杰立科（上海）生物科技有限公司

Source(s) of funding：

Epigenictx CO,.LTD

Target disease：

atherosclerotic cardiovascular disease

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

主要目的：评估EPI-001T注射液治疗ASCVD或ASCVD风险等效者的耐受性和安全性，并确认后续研究的推荐剂量； 次要目的：评估EPI-001T注射液治疗ASCVD或ASCVD风险等效者的初步有效性、药代动力学特征及免疫原性。  

Objectives of Study：

The primary objective is to evaluate the tolerability and safety of EPI-001T injection in patients with ASCVD or ASCVD risk equivalents, and to determine the recommended dose for subsequent studies. The secondary objective is to assess the preliminary efficacy, pharmacokinetic characteristics and immunogenicity of EPI-001T injection in patients with ASCVD or ASCVD risk equivalents.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.筛选时年龄为18周岁～75周岁（含临界值）的男性或女性受试者。
2.已确诊ASCVD病史（冠心病CHD、脑血管疾病CVD或外周动脉疾病PAD）或ASCVD风险等效人群（如：2型糖尿病、家族性高胆固醇血症FH、Framingham风险评分或等效评分评估的心血管事件风险达到20%或以上者）。
3.筛选时体重≥40kg，体重指数BMI＞18kg/m^2。
4.筛选时受试者必须符合以下实验室标准： 血常规：中性粒细胞绝对计数（ANC）≥1.5×10^9/L，血小板（PLT）≥100×10^9/L，血红蛋白（HGB）≥90 g/L；肝功能：天门冬氨酸氨基转移酶（AST）、丙氨酸氨基转移酶（ALT）、碱性磷酸酶（ALP）＜2.0×ULN，总胆红素（TBIL）≤1.5×ULN（吉尔伯特综合征患者TBIL≤2×ULN）；肾功能：血清肌酐（Cr）≤1.5×ULN，且肾小球滤过率（GFR）＞60mL/min*1.73m^2；凝血功能：凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、国际标准化比值（INR）＜1.5×ULN；空腹甘油三酯TG≤4.5mmol/L（400mg/dL）.
5.接受中等强度以上他汀类药物联合或不联合依折麦布稳定治疗至少4周（他汀不耐受*的受试者须稳定使用依折麦布至少4周），且LDL-C水平 ≥2.6 mmol/L（100 mg/dL）（ASCVD等效风险者）；或合并ASCVD极高危受试者LDL-C水平 ≥1.8 mmol/L（70 mg/dL）或超高危受试者LDL-C水平≥1.4mmol/L。
6.受试者（男性和有生育可能的女性）及其性伴侣愿意自筛选至研究药物末次给药后6个月内无生育计划，且自愿采取有效的避孕措施，且无捐精、捐卵计划。
7.受试者能够理解本临床试验的程序和方法，同意参与研究，并自愿签署知情同意书，且研究者判断能够遵守方案要求者。

Inclusion criteria

1. Male or female subjects aged 18 to 75 years (inclusive) will be screened. 2. Individuals with a confirmed history of ASCVD (coronary heart disease CHD, cerebrovascular disease CVD, or peripheral artery disease PAD) or those belonging to equivalent ASCVD risk groups (such as individuals with type 2 diabetes, familial hypercholesterolemia FH, or those with a Framingham risk score or an equivalent score indicating a cardiovascular event risk of 20% or higher). 3. During the screening process, individuals with a weight of 40 kg or more and a body mass index (BMI) greater than 18 kg/m^2 were included. 4. During the screening process, the subjects must meet the following laboratory standards: Blood routine: Absolute neutrophil count (ANC) >= 1.5×10^9/L, platelet (PLT) >= 100×10^9/L, hemoglobin (HGB) >= 90 g/L; Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) < 2.0×ULN, total bilirubin (TBIL) <= 1.5×ULN (for Gilbert syndrome patients, TBIL <= 2×ULN); Kidney function: Serum creatinine (Cr) <= 1.5×ULN, and glomerular filtration rate (GFR) > 60 mL/min*1.73m^2; Coagulation function: Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) < 1.5×ULN; Fasting triglycerides (TG) <= 4.5 mmol/L (400 mg/dL). 5. Receive stable treatment with moderate-intensity or higher statin drugs (combined with or without ezetimibe) for at least 4 weeks (for subjects with statin intolerance*, they must have been using ezetimibe for at least 4 weeks), and have a LDL-C level of >= 2.6 mmol/L (100 mg/dL) (for subjects with equivalent ASCVD risk); or for subjects with extremely high-risk ASCVD, have a LDL-C level of >= 1.8 mmol/L (70 mg/dL) or for subjects with very high-risk ASCVD, have a LDL-C level of >= 1.4 mmol/L. 6. The subjects (both male and female individuals with reproductive potential) and their sexual partners are willing to undergo pre-screening until 6 months after the last administration of the study drug, during which they have no intention of having children, and they voluntarily adopt effective contraceptive measures, and have no plans for sperm donation or egg donation. 7. The subjects are able to understand the procedures and methods of this clinical trial, agree to participate in the study, voluntarily sign the informed consent form, and the investigator determines that they can comply with the requirements of the protocol.

排除标准：

1.既往合并用药或治疗规定： 既往使用过除外他汀和依折麦布的影响血脂代谢的药物或治疗:a.接受研究药物前至少14天内（或药物5个半衰期内，以较长者为准）使用过任何影响血脂代谢的处方药、非处方药、中草药/中成药、保健品或营养补充剂或；3个月内使用过PCSK9单抗或；1年内使用过PCSK9小核酸药物或ASO或；既往接受过PCSK9基因治疗者；正在参加其他降脂类药物临床试验者；或曾经使用过研究药物者；b.筛选前1年内进行过脂蛋白血浆置换治疗；c.筛选前参加过另一项试验用非生物制剂（筛选前30天或5个半衰期内给药，以较长者为准）或试验用生物制剂（抗体或其他）（筛选前3个月或5个半衰期内，以较长者为准）的临床研究；d.入组前14天内进行抗血栓治疗（如：华法林、达比加群、阿哌沙班）者。
2.既往药物过敏史：经研究者评估，受试者对脂质纳米颗粒（LNP）所含药物或LNP-mRNA疫苗成分过敏，或曾因LNP类药物治疗发生不良反应。
3.基因诊断为纯合型FH(HoFH)、双重杂合型FH或复合杂合型FH的受试者。
4.既往合并疾病的规定：a.筛选时，存在纽约心脏病协会（NYHA）定义的Ⅲ-Ⅳ级心力衰竭，或左心室心脏射血分数<50%，或QTc间期延长（女性>470ms、男性>450ms）。 b. 筛选前3个月内有控制不佳的严重心律失常，如药物控制不佳的反复和高度症状性室性心动过速、快速心室反应性房颤或室上性心动过速。 c.筛选前3个月内有心肌梗死、不稳定心绞痛、经皮冠状动脉介入术、冠状动脉旁路搭桥术、严重深静脉血栓或肺栓塞；筛选前6个月内发生脑血管意外或计划在主研究期间进行心脏手术或心脏血运重建术等。d.接受常规治疗控制不佳的高血压患者（收缩压（SBP）≥160mmHg和/或舒张压（DBP）≥100mmHg）。e.控制不佳的糖尿病患者（糖化血红蛋白>8.5%）; f.患有对血脂水平有明显影响且无法控制的疾病，如肾病综合征、严重的肝脏疾病、库欣综合征、甲状腺功能异常等（筛选前甲状腺功能减退者经稳定甲状腺替代治疗≥28天，且TSH检测正常，并同意在研究中维持甲状腺替代药物剂量不变者可考虑入组）。g.易出血或有凝血障碍病史（如肝硬化、恶性血液病、抗磷脂抗体综合征）者; h.筛选前5年内有恶性肿瘤病史者（已根治的皮肤基底细胞癌、皮肤鳞状细胞癌、宫颈原位癌、低级别前列腺原位癌及已根治的甲状腺乳头状癌除外）。
5.预期生存期＜2年者。
6.合并传染病规定： a.已知或怀疑有系统性病毒、寄生虫或真菌感染者，或预计在筛选后14天内接受抗生素治疗者。b.筛选时人类免疫缺陷病毒（HIV）抗体阳性；梅毒抗体阳性；乙肝表面抗原（HBsAg）阳性者必须HBV DNA低于检测下限可入组；丙肝病毒抗体（HCV Ab）阳性者必须HCV RNA低于检测下限可入组。
7.其他规定： a.筛查前 3 个月内有持续酒精滥用史（每周饮酒量＞14个酒精单位，1瓶350ml的啤酒、120ml葡萄酒或30ml酒精度40%的烈酒为1个酒精单位）。b.筛选前3个月内献血超过500 mL者。c.妊娠或正在哺乳期的女性。d.根据研究者的判断，任何不适合参与研究的安全问题或个人状况，包括但不限于干扰评价或限制参与试验的其他血液系统、消化系统或中枢神经（包括脑血管疾病、退行性疾病）等系统疾病者；药物治疗不能充分控制的严重精神疾病者；筛选前3年内有吸毒史者；不愿遵守研究程序，或不愿充分合作者；不能参与临床试验的其他情况。

Exclusion criteria：

1. Previous concomitant medications or treatments: Previous use of drugs or treatments that affect lipid metabolism, excluding statins and ezetimibe: a. At least 14 days before receiving the study drug (or within 5 half-lives of the drug, whichever is longer), used any prescription drugs, over-the-counter drugs, herbal medicines/mass-produced Chinese medicines, health supplements or nutritional supplements that affect lipid metabolism; used PCSK9 monoclonal antibody within 3 months; used PCSK9 small nucleic acid drugs or ASO within 1 year; had received PCSK9 gene therapy before; was participating in other lipid-lowering drug clinical trials; or had used the study drug before; b. Had undergone lipoprotein plasma exchange treatment within 1 year before screening; c. Had participated in another clinical study using non-biological agents (administered within 30 days or 5 half-lives before screening, whichever is longer) or biological agents (antibodies or others) (administered within 3 months or 5 half-lives before screening, whichever is longer) before screening; d. Had received antithrombotic treatment (such as warfarin, dabigatran, apixaban) within 14 days before enrollment. 2. Previous history of drug allergy: Based on the assessment by the investigators, the subjects were found to be allergic to the drugs contained in the lipid nanoparticles (LNP), or to the components of the LNP-mRNA vaccine, or had experienced adverse reactions due to LNP-based drug treatments. 3. Subjects with homozygous FH (HoFH), double heterozygous FH or compound heterozygous FH identified through genetic testing. 4. Regulations on pre-existing comorbidities: a. During the screening process, there is NYHA-defined grade Ⅲ-Ⅳ heart failure, or left ventricular ejection fraction < 50%, or prolonged QTc interval (for females > 470ms, for males > 450ms). b. Within the past 3 months before screening, there are severe arrhythmias that are not well controlled, such as recurrent and highly symptomatic ventricular tachycardia, rapid ventricular reactivity atrial fibrillation or supraventricular tachycardia, when the condition is not well controlled by medication. c. Within the past 3 months before screening, there is myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, coronary artery bypass grafting, severe deep vein thrombosis or pulmonary embolism; within the past 6 months before screening, there has been cerebrovascular accident or planned cardiac surgery or cardiac revascularization during the main study period. d. Patients with poorly controlled hypertension who are receiving conventional treatment (systolic blood pressure (SBP) >= 160mmHg and/or diastolic blood pressure (DBP) ≥ 100mmHg). e. Patients with poorly controlled diabetes (glycated hemoglobin > 8.5%). f. Patients with diseases that significantly affect lipid levels and are uncontrolled, such as nephrotic syndrome, severe liver disease, Cushing's syndrome, thyroid dysfunction, etc. (patients with hypothyroidism before screening who have received stable thyroid replacement treatment for >= 28 days, with normal TSH test results, and agree to maintain the same thyroid replacement drug dosage during the study can be considered for inclusion). g. Patients with bleeding tendencies or a history of coagulation disorders (such as liver cirrhosis, malignant hematological diseases, antiphospholipid syndrome), etc. h. Patients with a history of malignant tumors within the past 5 years (excluding cured skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, low-grade prostate carcinoma, and cured thyroid papillary carcinoma). 5. Those with an expected survival period of less than 2 years. 6. Merged Infection Regulations: a. Individuals who are known or suspected to have systemic viruses, parasites, or fungi, or who are expected to receive antibiotic treatment within 14 days after screening. b. Those with positive human immunodeficiency virus (HIV) antibody at screening; positive syphilis antibody; positive hepatitis B surface antigen (HBsAg) must have HBV DNA below the detection limit to be eligible for enrollment; those with positive hepatitis C virus antibody (HCV Ab) must have HCV RNA below the detection limit to be eligible. 7. Other regulations: a. Within 3 months prior to screening, there was a continuous history of alcohol abuse (more than 14 alcohol units per week, 1 bottle of 350ml beer, 120ml wine or 30ml alcohol with an 40% alcohol content is considered as 1 alcohol unit). b. Those who donated blood more than 500 mL within 3 months prior to screening. c. Pregnant or lactating women. d. According to the researcher's judgment, any safety issues or personal conditions that are not suitable for participating in the study, including but not limited to diseases in other systems such as the blood system, digestive system or central nervous system (including cerebrovascular diseases, degenerative diseases), etc.; patients with severe mental disorders that cannot be adequately controlled by medication; those who refused to follow the research procedures or were unwilling to fully cooperate; other situations that prevent participation in clinical trials.

研究实施时间：

Study execute time：

从 From 2025-11-27 00:00:00至 To 2027-11-27 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-15 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

0.6mg/kg剂量组

样本量：

6

Group：

The 0.6 mg/kg dosage group

Sample size：

干预措施：

EPI-001T注射液，0.6mg/kg，单次输注

干预措施代码：

Intervention：

EPI-001T injection, 0.6mg/kg, single infusion

Intervention code：

组别：

剂量拓展队列2

样本量：

10

Group：

Dose Expansion Cohort 2

Sample size：

干预措施：

OBD剂量，多次给药

干预措施代码：

Intervention：

OBD dosage, multiple administrations

Intervention code：

组别：

剂量拓展队列1

样本量：

10

Group：

Dose Expansion Cohort 1

Sample size：

干预措施：

OBD剂量，单次给药

干预措施代码：

Intervention：

OBD dosage, single administration

Intervention code：

组别：

1.0mg/kg剂量组

样本量：

6

Group：

The 1.0 mg/kg dosage group

Sample size：

干预措施：

EPI-001T注射液，1.0mg/kg，单次输注

干预措施代码：

Intervention：

EPI-001T injection, 1.0 mg/kg, single infusion

Intervention code：

组别：

0.8mg/kg剂量组

样本量：

6

Group：

The 0.8 mg/kg dosage group

Sample size：

干预措施：

EPI-001T注射液，0.8mg/kg，单次输注

干预措施代码：

Intervention：

EPI-001T injection, 0.8mg/kg, single infusion

Intervention code：

组别：

0.3mg/kg剂量组

样本量：

6

Group：

The 0.3 mg/kg dosage group

Sample size：

干预措施：

EPI-001T注射液，0.3mg/kg，单次输注

干预措施代码：

Intervention：

EPI-001T injection, 0.3mg/kg, single infusion

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 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海交通大学医学院附属仁济医院 

单位级别：

三级甲等 

Institution
hospital：

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 上海市 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海交通大学医学院附属瑞金医院 

单位级别：

三级甲等 

Institution
hospital：

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

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：

分别于研究药物输注前2 h内，1 h，输注结束时，输注结束后0.5 h，1 h，2 h，4 h，6 h，8 h，12 h，24 h，48 h，72 h，W1、W2和W4采集

测量方法：

PK-mRNA及PK-阳离子脂质的Cmax、Tmax、AUC0-t、AUC0-∞、t1/2、CL/F、Vd/F等。

Measure time point of outcome：

-2h, 1h, end of infusion, 0.5h、1h、 2 h，4 h，6 h，8 h，12 h，24 h，48 h、72 h after infusion, W1, W2, W4.

Measure method：

PK-mRNA and PK-cationic lipids' Cmax, Tmax, AUC0-t，AUC0-∞，t1/2，CL/F，Vd/F，etc.

指标中文名：

其他血脂指标

指标类型：

次要指标

Outcome：

Other lipid indicators

Type：

Secondary indicator

测量时间点：

整个研究期间

测量方法：

其他血脂指标较基线的经时百分比变化。

Measure time point of outcome：

Throughout the entire study period

Measure method：

The percentage changes over time of other lipid indicators compared to the baseline.

指标中文名：

体格检查/生命体征

指标类型：

主要指标

Outcome：

Physical examination / Vital signs

Type：

Primary indicator

测量时间点：

整个研究期间

测量方法：

体格检查/生命体征较基线变化情况

Measure time point of outcome：

Throughout the entire study period

Measure method：

Physical examination / Changes in vital signs compared to baseline

指标中文名：

12导联心电图

指标类型：

主要指标

Outcome：

12-lead electrocardiogram

Type：

Primary indicator

测量时间点：

整个研究期间

测量方法：

12导联心电图检测指标情况较基线变化情况

Measure time point of outcome：

Throughout the entire study period

Measure method：

The changes in the 12-lead electrocardiogram detection indicators compared to the baseline values

指标中文名：

不良事件、严重不良事件、特别关注不良事件发生率

指标类型：

主要指标

Outcome：

Incidence rates of AEs、SAEs and AESIs

Type：

Primary indicator

测量时间点：

整个研究期间

测量方法：

不良事件发生频率

Measure time point of outcome：

Throughout the entire study period

Measure method：

Frequency of adverse events

指标中文名：

C反应蛋白

指标类型：

主要指标

Outcome：

C-reactive protein

Type：

Primary indicator

测量时间点：

D1研究药物输注前2h内，输注1h，输注结束时，输注结束后2h和12h、24 h、48 h、72 h、W1、W2、W4、W6、W8、W12、W16、W24、W36、W52采集

测量方法：

C反应蛋白较基线变化情况

Measure time point of outcome：

D1（-2h、1h、end of infusion, 2 h、12 h、24h 48h 、72 h after infusion、W1、W2、W4、W6、W8、W12、W16、W24、W36、W52）

Measure method：

The changes in C-reactive protein compared to the baseline level

指标中文名：

Anti-PEG

指标类型：

次要指标

Outcome：

Anti-PEG

Type：

Secondary indicator

测量时间点：

D1在研究药物输注前2 h内，输注结束后2h、4h、8h、24h、72 h、W1、W2、W4采集

测量方法：

Anti-PEG抗体滴度。

Measure time point of outcome：

-2h, 2h、4h、8h、24h、72 h after infusion, W1, W2, W4.

Measure method：

Anti-PEG antibody titer.

指标中文名：

PCSK9

指标类型：

次要指标

Outcome：

PCSK9

Type：

Secondary indicator

测量时间点：

整个研究期间

测量方法：

PCSK9检测值较基线的经时百分比变化；

Measure time point of outcome：

Throughout the entire study period

Measure method：

The percentage change in the PCSK9 detection value compared to the baseline over time;

指标中文名：

实验室检查指标（血常规、血生化、尿常规、凝血功能等）

指标类型：

主要指标

Outcome：

Laboratory test indicators (such as blood routine, blood biochemistry, urine routine, coagulation function, etc.)

Type：

Primary indicator

测量时间点：

整个研究期间

测量方法：

实验室检查指标（血常规、血生化、尿常规、凝血功能等）较基线变化情况

Measure time point of outcome：

Throughout the entire study period

Measure method：

The changes in laboratory test indicators (such as blood routine, blood biochemistry, urine routine, coagulation function, etc.) compared to the baseline values

指标中文名：

LDL-C

指标类型：

次要指标

Outcome：

LDL-C

Type：

Secondary indicator

测量时间点：

整个研究期间

测量方法：

LDL-C较基线的经时百分比变化；

Measure time point of outcome：

Throughout the entire study period

Measure method：

The percentage change in LDL-C from baseline over time;

采集人体标本：

Collecting sample(s)
from participants：

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：

标本中文名：

全血

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

无

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

None

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：

None

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）：

NA

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

NA

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：

易迪西EDC系统

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

Clinflash EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-12-19 11:38:11