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：	ChiCTR2500098700
最近更新日期： Date of Last Refreshed on：	2025-03-12 15:53:20
注册时间： Date of Registration：	2025-03-12 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项随机、双盲、安慰剂对照、单次给药、剂量递增评价KYS202004A注射液在健康成年受试者中的安全性、耐受性及药代动力学的首次人体临床研究
Public title：	The first randomized, double-blind, placebo-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of KYS202004A injection in healthy adult subjects
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项随机、双盲、安慰剂对照、单次给药、剂量递增评价KYS202004A注射液在健康成年受试者中的安全性、耐受性及药代动力学的首次人体临床研究
Scientific title：	The first randomized, double-blind, placebo-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of KYS202004A injection in healthy adult subjects
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：	景娇	研究负责人：	缪丽燕
Applicant：	Jing Jiao	Study leader：	Miao Liyan
申请注册联系人电话： Applicant telephone：	+86 189 6229 5533	研究负责人电话： Study leader's telephone：	+86 512 6797 2858
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：	zhuchangle0106@163.com	研究负责人电子邮件： Study leader's E-mail：	miaolysuzhou@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：	江苏省连云港市经济技术开发区江宁工业城康缘路58号	研究负责人通讯地址：	苏州市姑苏区平海路899号
Applicant address：	No.58 Kangyuan Road Jiangning Industrial City Lianyungang Economic and Technological Development Zone Jiangsu Province	Study leader's address：	No. 899, Pinghai Road, Gusu District, Suzhou
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：	江苏康缘药业股份有限公司
Applicant's institution：	Jiangsu Kangyuan Pharmaceutical Co., LTD Jiangsu Kangyuan Pharmaceutical Co. LTD
研究负责人所在单位：	苏州大学附属第一医院
Affiliation of the Leader：	The First Affiliated Hospital of Soochow University

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：	(2024)伦审批第521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：	苏州大学附属第一医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of the First Affiliated Hospital of Soochow University
伦理委员会批准日期： Date of approved by ethic committee：	2024-12-10 00:00:00
伦理委员会联系人：	陈罡
Contact Name of the ethic committee：	Chen Gang
伦理委员会联系地址：	江苏省苏州市姑苏区平海路899号苏大附一院总院综合楼1312办公室
Contact Address of the ethic committee：	Room 1312, General Hospital, Suzhou University, No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 512 6797 2861	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：

苏州大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Soochow University

研究实施负责（组长）单位地址：

苏州市姑苏区平海路899号

Primary sponsor's address：

No. 899, Pinghai Road, Gusu District, Suzhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu Province	City：
单位(医院)：	江苏康缘药业股份有限公司	具体地址：	江苏省连云港市经济技术开发区江宁工业城康缘路58号
Institution hospital：	Jiangsu Kangyuan Pharmaceutical Co., LTD	Address：	No.58 Kangyuan Road, Jiangning Industrial City, Lianyungang Economic and Technological Development Zone, Jiangsu Province

经费或物资来源：

江苏康缘药业股份有限公司

Source(s) of funding：

Jiangsu Kangyuan Pharmaceutical Co., LTD

研究疾病：

银屑病

Target disease：

Psoriasis

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：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

主要目的：评价在健康成年受试者中单次注射不同剂量KYS202004A注射液后的安全性和耐受性。次要目的：评价在健康成年受试者中单次注射不同剂量KYS202004A注射液后的药代动力学（PK）特征。评价在健康成年受试者中单次注射不同剂量KYS202004A注射液后的免疫原性的情况。探索性目的：探索在健康成年受试者中单次注射不同剂量KYS202004A注射液后生物标志物变化。

Objectives of Study：

Main purpose: To evaluate the safety and tolerability of a single injection of KYS202004A at different doses in healthy adult subjects. Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of KYS202004A injection after a single injection of different doses in healthy adult subjects. To evaluate the immunogenicity of a single injection of KYS202004A at different doses in healthy adult subjects. Exploratory purpose: To explore the changes of biomarkers after a single injection of KYS202004A at different doses in healthy adult subjects.

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

1.Voluntarily participate in the study and obtain informed consent prior to any study-related evaluation;
2. Aged between 18 and 55 years (including the cut-off) at the time of the screening visit, male or female;
3. At the time of screening visit, the weight of male subjects should not be less than 50 kg and that of female subjects should not be less than 45 kg. Body mass index in the range of 19.0 ~ 26.0 kg/m^2 (including the critical value);
4.During screening and baseline visit, subjects were judged to be in good health (platelet count should not be lower than the lower limit of normal) according to previous medical history, vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, etc.;
5.The subject (including the partner) agrees to voluntarily take effective contraceptive measures from the date of signing the informed consent to 6 months after the administration of the drug; The blood pregnancy test for female subjects must be negative and non-lactating; No sperm or egg donation within 6 months after self-medication;
6.Be able to communicate well with the investigator and be willing to comply with visits, study treatments, laboratory tests, and other research-related procedures and requirements as specified in the study protocol.

排除标准：

1.对试验用药品或其辅料过敏，或有严重过敏史（包括任何食物过敏或药物过敏）； 2.筛选访视时既往存在重大中枢神经系统、呼吸系统、心血管系统、消化系统、血液系统、内分泌系统、肌肉骨骼疾病、泌尿系统、自身免疫性疾病或肿瘤等任何疾病或身体状况，或现存任何急性疾病； 3.既往存在中度到重度充血性心力衰竭（纽约心脏病协会分级标准为III或IV级）病史； 4.既往接受过器官移植； 5.既往存在慢性或复发性感染性疾病，或真菌、寄生虫或霉菌性病原体引起的全身性感染，或其他机会性感染史； 6.已知的活动性或潜伏性结核病史、或未得到充分治疗的潜伏性结核感染、或结核病患者接触史； 7.筛选前6个月内发生过严重的骨骼或关节感染，或筛选前3个月内发生过严重感染（如因感染住院、或因感染接受过肠外抗生素治疗），或筛选前3个月内发生过带状疱疹病毒感染； 8.乙型肝炎表面抗原（HBsAg）阳性，或丙型肝炎抗体（HCV-Ab）阳性，或人免疫缺陷病毒抗体（HIV-Ab）阳性，或梅毒螺旋体抗体（TP-Ab）阳性； 9.存在任何急性感染，或具有任何感染的症状或体征； 10.既往存在严重出血、或筛选时存在皮肤伤口、手术部位、创伤部位、粘膜严重溃疡或骨折没有完全愈合，或在筛选前6个月内发生过活动性胃十二指肠溃疡、肠梗阻、溃疡性结肠炎、食管胃底静脉曲张、胃肠道穿孔，或存在其他出血风险； 11.12 导联心电图异常且有临床意义，如：男性QTcF间期（Fridericia校正）＞450 ms，女性＞470 ms； 12.血清肌酐清除率（Ccr）< 90 mL/min（根据Cockcroft-Gault公式计算）； 13.已知或怀疑药物滥用史（如：吗啡、甲基安非他明、氯胺酮、二亚甲基双氧安非他明、四氢大麻酚酸等），或基线期药物筛查试验阳性； 14.筛选前1年内酗酒（每周饮酒超过14个标准单位，1个标准单位含14 g酒精，如5%的啤酒360 ml、40%的烈酒45 ml、12%的葡萄酒120 ml），或基线期酒精呼气测试值大于正常值上限；或不能遵守研究期间禁止饮酒规定； 15.筛选前3个月内每天吸烟超过5支，或不能遵守研究期间禁止吸烟规定； 16.不同意或无法保证在试验首次给药前48 h至出院不摄取任何含有或代谢后产生咖啡因或黄嘌呤食物或饮料（如咖啡、茶、巧克力）； 17.筛选前3个月内接受过疫苗、或筛选前30天内接受过任何疫苗、或计划在研究期间接受任何疫苗； 18.筛选前6个月内接受了任何研究药物治疗或参加任何药物/研究器械试验； 19.给药前14天至最后一次访视期间，无法保证不使用任何药物（研究者允许使用的药物除外），包括处方药和非处方药、维生素、保健品及中草药； 20.给药前30天内接受过重大外科手术或在本研究期间内计划接受重大外科手术； 21.筛选前3个月内曾献血或失血量>=400毫升者或接受输血者； 22.存在有其它严重的系统性疾病或实验室检查异常或其他原因而不适合参加本研究的。

Exclusion criteria：

1. Allergy to the investigational drug or its excipients, or a history of severe allergies (including any food allergies or drug allergies); 2. Any previous disease or physical condition such as major central nervous system, respiratory system, cardiovascular system, digestive system, blood system, endocrine system, musculoskeletal disease, urinary system, autoimmune disease or tumor at the time of the screening visit, or any existing acute disease; 3. Previous history of moderate to severe congestive heart failure (grade III or IV on the New York Heart Association grading criteria); 4. Previous organ transplantation; 5. History of chronic or recurrent infectious diseases, or systemic infections caused by fungal, parasitic or fungal pathogens, or other opportunistic infections; 6. Known history of active or latent tuberculosis, or inadequately treated latent tuberculosis infection, or history of contact with tuberculosis patients; 7. Severe bone or joint infection within 6 months before screening, or serious infection within 3 months before screening (such as hospitalization for infection, or parenteral antibiotic treatment for infection), or herpes zoster virus infection within 3 months before screening; 8. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis C antibody (HCV-Ab), or positive for human immunodeficiency virus antibody (HIV-Ab), or positive for Treponema pallidum antibody (TP-Ab); 9. Presence of any acute infection, or with any signs or symptoms of infection; 10. Previous severe bleeding, or severe ulcers or fractures of skin wounds, surgical sites, trauma sites, mucous membranes that have not healed completely at the time of screening, or active gastroduodenal ulcers, intestinal obstruction, ulcerative colitis, esophageal and gastric varices, gastrointestinal perforation, or other bleeding risks within 6 months prior to screening; 11.12 Abnormal and clinically significant lead ECG, e.g., QTcF interval (Fridericia's correction) >450 ms for males and 470 ms for females> 12. Serum creatinine clearance (Ccr) < 90 mL/min (calculated according to the Cockcroft-Gault formula); 13. Known or suspected history of drug abuse (such as: morphine, methamphetamine, ketamine, methylenedioxyamphetamine, tetrahydrocannabinolic acid, etc.), or positive drug screening test at baseline; 14. Alcohol abuse within 1 year prior to screening (drinking more than 14 standard units per week, 1 standard unit containing 14 g of alcohol, such as 360 ml of 5% beer, 45 ml of 40% spirits, 120 ml of 12% wine), or the breath test value of alcohol in the baseline period is greater than the upper limit of normal; or unable to comply with the prohibition of alcohol consumption for the duration of the study; 15. Smoking more than 5 cigarettes per day within 3 months prior to screening, or unable to comply with the smoking ban during the study; 16. Do not agree or cannot guarantee that you will not ingest any food or drink (such as coffee, tea, chocolate) that contains or produces caffeine or xanthine after being metabolized from 48 hours before the first dose of the trial to discharge; 17. Received a vaccine within 3 months prior to screening, or received any vaccine within 30 days prior to screening, or plans to receive any vaccine during the study; 18. Received any investigational drug treatment or participated in any drug/investigational device trial within 6 months prior to screening; 19. During the period from 14 days before dosing to the last visit, it is impossible to guarantee that no drugs (except for drugs allowed by the investigator), including prescription and over-the-counter drugs, vitamins, health products and Chinese herbal medicines; 20. Major surgical surgery within 30 days prior to dosing or planned major surgical operation during this study period; 21. Those who have donated blood or lost blood within 3 months before screening>=400 ml or received blood transfusion; 22. Those who have other serious systemic diseases or abnormal laboratory tests or other reasons that make them unsuitable for participating in this study.

研究实施时间：

Study execute time：

从 From 2024-11-18 00:00:00至 To 2026-06-18 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-03-18 00:00:00 至 To 2025-11-28 00:00:00

干预措施：

Interventions：

组别：	试验组-0.3mg/kg剂量	样本量：	6
Group：	Experimental group -0.3mg/kg dose	Sample size：	6
干预措施：	给受试者静脉滴注KYS202004A，剂量及制备：0.3mg/kg的KYS202004A注射液溶解于100 mL的5%葡萄糖注射液中，输液体积：100 mL，输注时长： 20~40min，输注速度： 2.5~5 mL/min	干预措施代码：
Intervention：	Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 0.3mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the infusion volume was 100 mL, the infusion duration was 20~40min, and the infusion speed was 2.5~5 mL/min	Intervention code：

组别：	试验组-0.9mg/kg剂量	样本量：	6
Group：	Experimental group -0.9mg/kg dose	Sample size：	6
干预措施：	给受试者静脉滴注 KYS202004A，剂量及制备：0.9mg/kg的KYS202004A注射液溶解于100 mL的5%葡萄糖注射液中，输液体积：100 mL，输注时长： 20~40min，输注速度： 2.5~5 mL/min	干预措施代码：
Intervention：	Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 0.9mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the infusion volume was 100 mL, the infusion duration was 20~40min, and the infusion speed was 2.5~5 mL/min	Intervention code：

组别：	试验组-1.8mg/kg剂量	样本量：	6
Group：	Experimental group -1.8mg/kg dose	Sample size：	6
干预措施：	给受试者静脉滴注 KYS202004A，剂量及制备：1.8mg/kg的KYS202004A注射液溶解于100 mL的5%葡萄糖注射液中，输液体积：100 mL，输注时长： 20~40min，输注速度： 2.5~5 mL/min	干预措施代码：
Intervention：	Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 1.8mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the infusion volume was 100 mL, the infusion duration was 20~40min, and the infusion speed was 2.5~5 mL/min	Intervention code：

组别：	试验组-3.0mg/kg剂量	样本量：	6
Group：	Experimental group -3.0mg/kg dose	Sample size：	6
干预措施：	给受试者静脉滴注 KYS202004A，剂量及制备：3.0mg/kg的KYS202004A注射液溶解于100 mL的5%葡萄糖注射液中，输液体积：100 mL，输注时长： 20~40min，输注速度： 2.5~5 mL/min	干预措施代码：
Intervention：	Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 3.0mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the infusion volume was 100 mL, the infusion duration was 20~40min, and the infusion speed was 2.5~5 mL/min	Intervention code：

组别：	试验组-4.5mg/kg剂量	样本量：	6
Group：	Experimental group -4.5mg/kg dose	Sample size：	6
干预措施：	给受试者静脉滴注 KYS202004A，剂量及制备：4.5mg/kg的KYS202004A注射液溶解于100 mL的5%葡萄糖注射液中，输液体积：100 mL，输注时长： 20~40min，输注速度： 2.5~5 mL/min	干预措施代码：
Intervention：	Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 4.5mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the infusion volume was 100 mL, the infusion duration was 20~40min, and the infusion speed was 2.5~5 mL/min	Intervention code：

组别：	试验组-6.0mg/kg剂量	样本量：	6
Group：	Experimental group -6.0mg/kg dose	Sample size：	6
干预措施：	给受试者静脉静滴注 KYS202004A，剂量及制备：6.0mg/kg的KYS202004A注射液溶解于100 mL的5%葡萄糖注射液中，输液体积：100 mL，输注时长： 20~40min，输注速度： 2.5~5 mL/min	干预措施代码：
Intervention：	Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 6.0mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the infusion volume was 100 mL, the infusion duration was 20~40min, and the infusion speed was 2.5~5 mL/min	Intervention code：

组别：	安慰剂组	样本量：	12
Group：	Placebo group	Sample size：	12
干预措施：	给受试者静脉静滴注安慰剂，剂量及制备：安慰剂注射液溶解于100 mL的5%葡萄糖注射液中，输液体积：100 mL，输注时长： 20~40min，输注速度： 2.5~5 mL/min	干预措施代码：
Intervention：	The subjects were given intravenous infusion of placebo, dosage and preparation: the placebo injection was dissolved in 100 mL 5% glucose injection, the infusion volume was 100 mL, the infusion duration was 20~40min, and the infusion speed was 2.5~5 mL/min	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	浙江	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	苏州大学附属第一医院	单位级别：	三甲
Institution hospital：	The First Affiliated Hospital of Soochow University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	生命体征	指标类型：	主要指标
Outcome：	Vital signs	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	体格检查	指标类型：	主要指标
Outcome：	Physical examination	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

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：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	达峰浓度（Cmax）	指标类型：	次要指标
Outcome：	Peak concentration	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	达峰时间（Tmax）	指标类型：	次要指标
Outcome：	Time to peak	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血药浓度-时间曲线下面积（AUC0-t, AUC 0-∞）	指标类型：	次要指标
Outcome：	Area under the plasma-drug concentration-time curve	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血浆消除半衰期（t1/2）	指标类型：	主要指标
Outcome：	Plasma elimination half-value period	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血浆清除率（CL）	指标类型：	次要指标
Outcome：	Plasma clearance	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	表观分布容积（V）	指标类型：	次要指标
Outcome：	Apparent volume of distribution	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	平均滞留时间（MRT）	指标类型：	次要指标
Outcome：	Mean residence time	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	给药后抗药抗体（ADA）的发生率	指标类型：	次要指标
Outcome：	Incidence of anti-drug antibodies (ADA) after administration	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	肿瘤坏死因子-α（TNF-α）水平及较基线的变化	指标类型：	次要指标
Outcome：	TNF-α levels and changes from baseline	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	白介素17A（IL-17A）水平及较基线的变化	指标类型：	次要指标
Outcome：	IL-17A levels and changes from baseline	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：	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：	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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	55	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）：

根据研究需要，根据筛选合格的顺序给予随机号。受试者的随机号由独立统计师采用区组随机化方法产生。独立统计师采用SAS V9.4的 PLAN 过程，用区组随机法生成48个随机号。各个剂量组的2例哨兵，均按照1:1的比例随机分配至KYS202004A和安慰剂组，其余6例按照5:1的比例随机分配至KYS202004A和安慰剂组。

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

According to the research needs, random number is given according to the order of screening. The random numbers of the subjects were generated by independent statisticians using block randomization. Independent statisticians used the PLAN procedure of SAS V9.4 to generate 48 random numbers using block randomization. Two sentries in each dose group were randomly assigned to KYS202004A and placebo group in a ratio of 1:1, and the other six were randomly assigned to KYS202004A and placebo group in a ratio of 5:1.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	本研究将以双盲方式进行，研究人员和受试者均不知道研究药物和安慰剂的分配情况。由申办单位或其指定的单位对每个试验组的试验药物和安慰剂进行编盲。
Blinding：	The study will be conducted in a double-blind manner, with neither the researchers nor the subjects knowing the distribution of the study drug and placebo. The test drug and placebo shall be blinded by the sponsor or its designated unit for each trial group.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
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）：	试验完结后通过论文发表形式公开；Medidata Clinical Cloud®；https://login.imedidata.com
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After the completion of the experiment, it will be published in the form of a paper. Medidata Clinical Cloud®; https://login.imedidata.com
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：	暂未确定/Not yet
注册人： Name of Registration：	2025-03-12 15:53:14