中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2300070027
最近更新日期： Date of Last Refreshed on：	2023-07-09 15:22:10
注册时间： Date of Registration：	2023-03-31 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项评估 SAK2001 在晚期实体瘤受试者中的安全性、耐受性、药代动力学特征以及初步抗肿瘤疗效的 I 期临床研究
Public title：	A phase I clinical study evaluating the safety, tolerability, pharmacokinetic profile, and initial antitumor efficacy of SAK2001 in subjects with advanced solid tumors
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项评估 SAK2001 在晚期实体瘤受试者中的安全性、耐受性、药代动力学特征以及初步抗肿瘤疗效的 I 期临床研究
Scientific title：	A phase I clinical study evaluating the safety, tolerability, pharmacokinetic profile, and initial antitumor efficacy of SAK2001 in subjects with advanced solid tumors
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：	刘健	研究负责人：	刘健
Applicant：	Liu Jian	Study leader：	Liu Jian
申请注册联系人电话： Applicant telephone：	+86 571 87236560	研究负责人电话： Study leader's telephone：	+86 571 87236560
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：	lindaliu87@zju.edu.cn	研究负责人电子邮件： Study leader's E-mail：	lindaliu87@zju.edu.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：	杭州市上城区79号	研究负责人通讯地址：	杭州市上城区79号
Applicant address：	79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang	Study leader's address：	79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang
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：	浙江大学医学院附属第一医院
Applicant's institution：	The First Affiliated Hospital, Zhejiang University School of Medicine
研究负责人所在单位：	浙江大学医学院附属第一医院
Affiliation of the Leader：	The First Affiliated Hospital, Zhejiang University School of Medicine

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：	2023伦审第（32）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：	浙江大学医学院附属第一医院临床研究伦理委员会
Name of the ethic committee：	Clinical Research Ethics Committee of he First Affiliated Hospital , Zhejiang University School of Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2023-02-23 00:00:00
伦理委员会联系人：	周惠丽
Contact Name of the ethic committee：	Zhou Huili
伦理委员会联系地址：	杭州市上城区79号
Contact Address of the ethic committee：	79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang
伦理委员会联系人电话： Contact phone of the ethic committee：		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：

浙江大学医学院附属第一医院

Primary sponsor：

The First Affiliated Hospital, Zhejiang University School of Medicine

研究实施负责（组长）单位地址：

杭州市上城区79号

Primary sponsor's address：

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	浙江	市(区县)：	杭州
Country：	China	Province：	Zhejiang	City：	Hangzhou
单位(医院)：	慧禹康成（杭州）医药科技有限公司	具体地址：	浙江省杭州市余杭区仓前街道文一西路1378号1幢E座二层209-9
Institution hospital：	Huiyu Kangcheng (Hangzhou) Pharmaceutical Technology Co., LTD.	Address：	209-9, Floor 2, Block E, Building 1, 1378 Wenyi Road West, Cangqian Street, Yuhang District

经费或物资来源：

慧禹康成（杭州）医药科技有限公司

Source(s) of funding：

Huiyu Kangcheng (Hangzhou) Pharmaceutical Technology Co., LTD.

研究疾病：

晚期实体瘤

Target disease：

Advanced solid tumor

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：

析因分组（即根据危险因素或暴露因素分组）

Study design：

Factorial

研究目的：

主要目的：评价SAK2001在晚期实体瘤受试者中的安全性和耐受性，并观察该药的剂量限制性毒性（DLT），确定其在人体中的最大耐受剂量（MTD），为后续临床研究提供剂量选择依据；次要目的：评价SAK2001在晚期实体瘤受试者中的药代动力学（PK）特征；初步评价SAK2001在晚期实体瘤受试者中的抗肿瘤疗效；比较SAK2001与多西他赛注射液（泰索帝?）的PK特征、安全性和抗肿瘤疗效。

Objectives of Study：

Main purpose: To evaluate the safety and tolerability of SAK2001 in subjects with advanced solid tumors, and to observe the dose-limiting toxicity (DLT) of SAK2001 to determine the maximum tolerated dose in humans (MTD) to provide the basis for dose selection in subsequent clinical studies; Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of SAK2001 in subjects with advanced solid tumors. To evaluate the antitumor effect of SAK2001 in patients with advanced solid tumors. The PK characteristics, safety and antitumor efficacy of SAK2001 and Docetaxel injection (Taxoteil ?) were compared.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

Subjects must meet all of the following criteria:
1. Written informed consent (ICF) must be signed before any research-specific procedure can be performed;
2. Aged 18-75 years (including upper and lower limits);
3. Subjects with advanced solid tumors confirmed histologically or cytologically by standard treatment failure or intolerance or relapse after treatment;
4. There was at least one measurable (increasing/expanding) or evaluable (increasing) tumor lesion (RECISTv 1.1 efficacy evaluation criteria);
5. The physical status score of the Eastern Oncology Collaboration Group (ECOG) was less than 1 point;
6. Expected survival >= 3 months;
7. Good organ function (no blood transfusion, blood products, or blood cell growth factors such as granulocyte colony stimulating factor within 2 weeks), including:
(1) Blood routine: neutrophil count (ANC) >= 1.5 x 10^9 /L, platelet count (PLT) >= 90 x 10^9/L, and hemoglobin (Hb) >= 90 g/L;
(2) Renal function: Serum creatinine <= 1.5 times the upper limit of normal (ULN) or calculated muscle Anhydride clearance (Ccr) > 60 mL/min. Ccr formula: male Ccr = [(140 - years of age) by weight (kg)] / [0.818 x Scr (mu mol/L)], women Ccr = 0.85 x [(140 - age) by weight (kg)]/[0.818 x Scr (mu mol/L)];
(3) Liver function: total bilirubin (TBIL) <= 1.5ULN, aspartate transaminase (AST) <= 2.5 times ULN, alanine transaminase (ALT) <= 2.5 times ULN (if liver metastasis exists during screening: aspartate transaminase (AST) <= 5 times ULN, alanine transaminase (ALT) <= 5 times ULN);
(4) Coagulation function: activated partial thromboplastin time (aPTT) <= 1.5 times ULN, coagulation proenzyme time (PT) is <= 1.5 ULN, and the International Normalized ratio (INR) is <= 1.5 ULN;
8. Women of reproductive age and all male subjects agree to use adequate contraceptive methods (such as condoms and intrauterine devices) during the trial period and for at least 6 months after the end of the study treatment; Blood human chorionic gonadotropin (hCG) pregnancy test results must be negative for female subjects of childbearing age within 7 days prior to first receiving the study drug; All male subjects were not allowed to donate sperm during the trial and for at least six months after the end of the study treatment;
9. Willingness and ability to comply with clinical protocol (as determined by the investigator).

排除标准：

如果受试者满足下列任一标准，则不能入组本研究： 1.哺乳期妇女； 2. 具有临床症状的脑转移、脊髓压迫、癌性脑膜炎，或有其他证据表明受试者脑、脊髓转移灶尚未控制的受试者； 3.≥2级周围神经病变(NCI CTCAE v5.0)； 4.严重的中枢神经系统或精神疾病病史，需要药物治疗(例如类固醇或抗癫痫药物)的严重癫痫或痴呆受试者； 5.严重的心血管疾病，包括但不限于：不稳定型心绞痛、有症状的冠状动脉疾病、严重心律失常、心肌梗塞、基线左室射血分数低于 50% 、心力衰竭，纽约心脏病学会(NYHA) 分级为II级及以上；具有临床意义的基线心电图QTc间期延长者(男性>450 ms，女性>470 ms)及其他不稳定的心脏疾病； 6.未控制的活动性严重感染(按照NCI CTCAE v5.0级别>2，须接受系统性抗感染治疗者，或给药前体温>38℃且无法解释者)； 7.具有其他重大疾病的症状或体征，包括但不限于：终末期器官衰竭、除癌症外的其他重大慢性疾病(如终末期糖尿病、 IV级高血压、严重凝血功能异常、中风或短暂性脑缺血发作、肺栓塞，或者入组本试验之前6个月内非导管相关性深静脉血栓、活动性自身免疫性疾病)； 8.5年内有其他恶性肿瘤病史(已治愈的宫颈癌或皮肤基底细胞癌除外)； 9.既往应用多西他赛进行姑息性化疗(辅助治疗如果应用多西他赛治疗，复发时间在末次用药后6个月以内) 或研究者认为其他不适合接受多西他赛单药治疗的情况； 10.对研究药物的辅料有严重过敏史(按照NCI CTCAE v5.0级别≥ 3)；研究药物辅料包括：维生素E、蛋黄卵磷脂、中链甘油三酸酯、蔗糖。 *扩展阶段对泰索帝@辅料成分包括吐温80、注射用乙醇严重过敏的受试者不建议纳入阳性对照组； 11.首次给药前4周内接受过放疗、化疗、手术(诊断性活检除外) 、免疫治疗或其他抗肿瘤(如生物制剂或激素等)治疗， 6周内接受过亚硝基脲类或丝裂霉素治疗，2周内或已知药物的5个半衰期内 (以时间长者为准) 接受过口服氟尿嘧啶类、小分子靶向药物、有抗肿瘤适应症的中药，且既往抗肿瘤治疗的不良反应无法恢复到 NCI CTCAE v5.0级别≤1 (脱发等研究者判断无安全风险的毒性除外)； 12.首次给药前4周内接受过任何临床试验药物治疗(如果确定受试者既往所用试验药物的5个半衰期<4周，也可以以5个半衰期为准)； 13.首次给药前2周内接受过对CYP3A代谢酶通路有显著影响的药物(包括但不限于：环孢素、特非那定、酮康唑、咪康唑、伊曲康唑、伏立康唑、红霉素、醋竹桃霉素、泰利霉素、克拉霉素、环孢霉素A 、艿法唑酮、奈非那韦、利托那韦、沙奎那韦、茚地那韦、替拉那韦、维拉帕米、地尔硫卓、巴比妥类、卡马西平、苯妥英、非那西汀、奥美拉唑、米达唑仑、三唑仑、阿扎莫林、利福平、奎尼丁等) 或给药前48 h内食用过对P450代谢酶通路有显著影响的食物(例如：葡萄柚以及含葡萄柚的食物等)； 14.首次给药前2周内接受过系统性使用的糖皮质激素(强的松>10 mg/天或等效价剂量的同类药物) 或其他免疫抑制剂治疗；注：除外以下情况：使用局部、眼部、关节腔内、鼻内和吸入型糖皮质激素治疗；短期使用糖皮质激素进行预防治疗(例如预防造影剂过敏)。 15.活动性乙型肝炎(乙肝表面抗原【HbsAg】阳性或核心抗体【HbcAb】阳性且 HBV-DNA> 1000 IU/ml (>10^3 拷贝/ml))，或丙型肝炎病毒感染[丙肝病毒抗体阳性且HCV-RNA阳性)、人类免疫缺陷病毒(HIV)检查阳性； 16.5年内有精神药物滥用或吸毒史(询问)； 17.无法控制的第三间隙积液； 18.其他严重的急性或慢性医学或精神状况，或者可能加重与参加试验或使用试验药物相关的风险的实验室检查异常，或者可能干扰试验结果解读的实验室检查异常，以及研究者认为不适宜参加本研究的其他任何情况。

Exclusion criteria：

Subjects will not be enrolled in this study if they meet any of the following criteria: 1. Lactating women; 2. Subjects with clinical symptoms of brain metastasis, spinal cord compression, cancerous meningitis, or other evidence of uncontrolled brain or spinal cord metastasis; 3. >= grade 2 peripheral neuropathy (NCI CTCAE v5.0); 4. Subjects with severe epilepsy or dementia who have a history of severe central nervous system or psychiatric disorders requiring medication (such as sterol or antiepileptic drugs); 5. Severe cardiovascular disease, including but not limited to: unstable angina, symptomatic coronary artery disease, severe arrhythmia, myocardial infarction, baseline left ventricular ejection fraction less than 50%, heart failure, New York College of Cardiology (NYHA) grade II or above; Clinically significant baseline ECG QTc interval prolongation (male > 450 ms, female > 470 ms) and other unstable heart disease; 6. Uncontrolled, active and severe infections (those requiring systemic anti-infective therapy according to the NCI CTCAE v5.0 level > 2, or those with unexplained pre-administration body temperature > 38 degree C); 7. Having symptoms or signs of other serious diseases, including but not limited to: End-stage organ failure, other major chronic diseases other than cancer (such as end-stage diabetes, grade IV hypertension, severe coagulation abnormalities, stroke or transient ischemic attack, pulmonary embolism, or non-catheter-associated deep vein thrombosis, active autoimmune disease within 6 months prior to inclusion in this trial); 8. A history of other malignancies (other than cured cervical cancer or basal cell carcinoma of the skin) within 5 years; 9. Previous docetaxel palliative chemotherapy (adjuvant therapy if docetaxel treatment, recurrence time within 6 months after the last dose) or other conditions in which docetaxel monotherapy was not considered appropriate by the investigator; 10. A history of severe allergy to excipients of the investigational drug (>= 3 according to NCI CTCAE v5.0 level) Study drug excipients included: vitamin E, egg yolk lecithin, medium chain triglyceride, sucrose. * In the expansion phase, subjects with severe allergy to Taxote@ excipients including Tine80 and ethanol for injection are not recommended to be included in the positive control group; 11. Radiotherapy, chemotherapy, surgery (other than diagnostic biopsy), immunotherapy or other antitumor (such as biologics or hormones) therapy within 4 weeks prior to initial administration, nitroso-urea or mitomycin therapy within 6 weeks, Received oral fluorouracil, small-molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications within 2 weeks or within 5 half-lives of known drugs (depending on the duration), and the adverse reactions of previous anti-tumor treatment could not be recovered to NCI CTCAE v5.0 level <= 1 (except for toxicity without safety risk as determined by researchers, such as hair loss); 12. Received any investigational drug within 4 weeks prior to initial dosing (if it is determined that the 5 half-life of the investigational drug previously used by the subject is < 4 weeks, 5 half-lives may also be used); 13. Received drugs with significant effects on the CYP3A metabolic enzyme pathway within 2 weeks prior to initial administration (including but not limited to: Cyclosporine, Terphenadine, ketoconazole, Miconazole, Itraconazole, Voriconazole, erythromycin, acetonamycin, Telycin, Clarithromycin, Cyclosporine A, Fasoldone, Nelfinavir, Ritonavir, Saquinavir, Indenavir, Tiranavir, Verapamil, Diltiazem, Barbiturates, carbamazepine, Phenytoin, Phenoxetine, Omeprazole, midazolam, triazolam, azamorine, rifampicin, quinidine, etc.) or food (e.g. Grapefruit and grapefruits containing foods) that significantly affected the P450 metabolic enzyme pathway within 48 h prior to administration; 14. Systemic use of glucocorticoids (prednisone > 10 mg/ day or equivalent equivalent dose of the same drug) or other immunosuppressant therapy within 2 weeks prior to initial administration. Note: Except in the following cases: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; Short-term use of corticosteroids for prophylactic treatment (e.g. to prevent hypersensitivity to contrast media); 15. Active hepatitis B (HbsAg positive or HbcAb positive with HBV-DNA > 1,000 IU/ml (> 10^3 copies/ml)), Or hepatitis C virus infection [HCV antibody positive and HCV-RNA positive), human immunodeficiency virus (HIV) test positive; 16. A history of psychoactive substance abuse or drug use within 5 years (inquiry); 17. Uncontrolled third space effusion; 18. Other severe acute or chronic medical or psychiatric conditions, or abnormalities in laboratory tests that may aggravate the risks associated with participation in the trial or with the use of the trial drug, or abnormalities in laboratory tests that may interfere with the interpretation of the test results, and any other conditions that the investigator deems inappropriate for participation in the study.

研究实施时间：

Study execute time：

从 From 2023-03-21 00:00:00至 To 2024-03-20 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-04-01 00:00:00 至 To 2024-03-31 00:00:00

干预措施：

Interventions：

组别：	剂量递增组(2.5mg/m2)	样本量：	1
Group：	Dose increasing group (2.5 mg/m2)	Sample size：	1
干预措施：	每 3 周给药一次(可根据安全性和 PK 数据对下一剂量组的给药剂量和给药频率进行调整；可根据情况再增加数个剂量组)。采用加速滴定和传统的“3+3”方法进行剂量递增。	干预措施代码：
Intervention：	Dosing every 3 weeks (the dose and frequency of dosing in the next dose group can be adjusted based on safety and PK data; Additional dose groups may be added as appropriate). Accelerated titration and the traditional "3 + 3" method were used for dose escalation.	Intervention code：

组别：	剂量递增组(7.5mg/m2)	样本量：	1
Group：	Dose increasing group (7.5 mg/m2)	Sample size：	1
干预措施：	每 3 周给药一次(可根据安全性和 PK 数据对下一剂量组的给药剂量和给药频率进行调整；可根据情况再增加数个剂量组)。采用加速滴定和传统的“3+3”方法进行剂量递增。	干预措施代码：
Intervention：	Dosing every 3 weeks (the dose and frequency of dosing in the next dose group can be adjusted based on safety and PK data; Additional dose groups may be added as appropriate). Accelerated titration and the traditional "3 + 3" method were used for dose escalation.	Intervention code：

组别：	剂量递增组(15mg/m2)	样本量：	1
Group：	Dose increasing group (15 mg/m2)	Sample size：	1
干预措施：	每 3 周给药一次(可根据安全性和 PK 数据对下一剂量组的给药剂量和给药频率进行调整；可根据情况再增加数个剂量组)。采用加速滴定和传统的“3+3”方法进行剂量递增。	干预措施代码：
Intervention：	Dosing every 3 weeks (the dose and frequency of dosing in the next dose group can be adjusted based on safety and PK data; Additional dose groups may be added as appropriate). Accelerated titration and the traditional "3 + 3" method were used for dose escalation.	Intervention code：

组别：	剂量递增组(25mg/m2)	样本量：	6
Group：	Dose increasing group (25 mg/m2)	Sample size：	6
干预措施：	每 3 周给药一次(可根据安全性和 PK 数据对下一剂量组的给药剂量和给药频率进行调整；可根据情况再增加数个剂量组)。采用加速滴定和传统的“3+3”方法进行剂量递增。	干预措施代码：
Intervention：	Dosing every 3 weeks (the dose and frequency of dosing in the next dose group can be adjusted based on safety and PK data; Additional dose groups may be added as appropriate). Accelerated titration and the traditional "3 + 3" method were used for dose escalation.	Intervention code：

组别：	剂量递增组(35mg/m2)	样本量：	6
Group：	Dose increasing group (35 mg/m2)	Sample size：	6
干预措施：	每 3 周给药一次(可根据安全性和 PK 数据对下一剂量组的给药剂量和给药频率进行调整；可根据情况再增加数个剂量组)。采用加速滴定和传统的“3+3”方法进行剂量递增。	干预措施代码：
Intervention：	Dosing every 3 weeks (the dose and frequency of dosing in the next dose group can be adjusted based on safety and PK data; Additional dose groups may be added as appropriate). Accelerated titration and the traditional "3 + 3" method were used for dose escalation.	Intervention code：

组别：	剂量递增组(45mg/m2)	样本量：	6
Group：	Dose increasing group (45 mg/m2)	Sample size：	6
干预措施：	每 3 周给药一次(可根据安全性和 PK 数据对下一剂量组的给药剂量和给药频率进行调整；可根据情况再增加数个剂量组)。采用加速滴定和传统的“3+3”方法进行剂量递增。	干预措施代码：
Intervention：	Dosing every 3 weeks (the dose and frequency of dosing in the next dose group can be adjusted based on safety and PK data; Additional dose groups may be added as appropriate). Accelerated titration and the traditional "3 + 3" method were used for dose escalation.	Intervention code：

组别：	剂量扩展组（SAK2001）	样本量：	36
Group：	Dose extension Group (SAK2001)	Sample size：	36
干预措施：	SAK2001 拟在 1-3 个剂量组与多西他赛注射液(泰索帝? ) 75 mg/m2 剂量对照进行剂量扩展研究，SAK2001 各剂量组和泰索帝? 组每组受试者例数 12 例，随机接受试验药物 SAK2001 或泰索帝? 。每 3 周为一个给药周期，治疗期每 2 个周期(±3 天)进行疗效评价。	干预措施代码：
Intervention：	SAK2001 intends to conduct a dose extension study comparing 1-3 dose groups with Docetaxel injection solution (Taxoteil) at a dose of 75 mg/m2. There are 12 subjects in each SAK2001 dose group and Taxoteil group, and the experimental drug SAK2001 or Taxoteil will be randomly accepted.	Intervention code：

组别：	剂量扩展组（泰索帝75 mg/m2 ）	样本量：	12
Group：	Dose extension group (Taxoteil 75 mg/m2)	Sample size：	12
干预措施：	SAK2001 拟在 1-3 个剂量组与多西他赛注射液(泰索帝? ) 75 mg/m2 剂量对照进行剂量扩展研究，SAK2001 各剂量组和泰索帝? 组每组受试者例数 12 例，随机接受试验药物 SAK2001 或泰索帝? 。每 3 周为一个给药周期，治疗期每 2 个周期(±3 天)进行疗效评价。	干预措施代码：
Intervention：	SAK2001 intends to conduct a dose extension study comparing 1-3 dose groups with Docetaxel injection solution (Taxoteil) at a dose of 75 mg/m2. There are 12 subjects in each SAK2001 dose group and Taxoteil group, and the experimental drug SAK2001 or Taxoteil will be randomly accepted.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	中国	市(区县)：	杭州
Country：	China	Province：	Zhejiang	City：	Hangzhou
单位(医院)：	浙江大学医学院附属第一医院	单位级别：	三级甲等
Institution hospital：	The First Affiliated Hospital, Zhejiang University School of Medicine	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	安全性	指标类型：	主要指标
Outcome：	Security	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特征	指标类型：	次要指标
Outcome：	PK characteristics	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疗效	指标类型：	次要指标
Outcome：	Curative effect	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	其它	说明	检测后立即销毁或保存至国家局核查1年之后销毁
Fate of sample：	0thers	Note：	After testing, it shall be destroyed immediately or stored for one year after verification by CFDI

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）：

由北京春天医药科技发展有限公司采用区组化随机方式进行随机。

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

The randomization method was adopted by Beijing Spring Medical Science and Technology Development Co., LTD.

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：	None
Blinding：	None

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）：	中国临床试验注册中心（http://www.chictr.org.cn/）
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	China Clinical Trial Registration Center (http://www.chictr.org.cn/)
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：	暂未确定/Not yet
注册人： Name of Registration：	2023-03-31 11:51:27