ChiCTR2500114954 版本V1.0 版本创建时间2025/12/19 12:48:32 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：

 ChiCTR2500114954 

最近更新日期：

Date of Last Refreshed on：

 2025-12-19 12:48:25 

注册时间：

Date of Registration：

 2025-12-19 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

评价GPN00068注射液在健康受试者中单次/多次静脉给药的安全性、耐受性和药代动力学特征的I期临床试验

Public title：

Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of GPN00068 Injection Following Single and Multiple Intravenous Doses in Healthy Subjects.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价GPN00068注射液在健康受试者中单次/多次静脉给药的安全性、耐受性和药代动力学特征的I期临床试验

Scientific title：

Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of GPN00068 Injection Following Single and Multiple Intravenous Doses in Healthy 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：

郑子明 

研究负责人：

张玉 

Applicant：

Zheng Ziming 

Study leader：

Zhang Yu 

申请注册联系人电话：

Applicant telephone：

 +86 130 3717 2142

研究负责人电话：

Study leader's
telephone：

+86 139 7129 2838

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：

 zhengziming1314@163.com

研究负责人电子邮件：

Study leader's E-mail：

 zhangwkp@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 华中科技大学

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：

中国湖北省武汉市江汉区解放大道1277号

研究负责人通讯地址：

中国湖北省武汉市江汉区解放大道1277号

Applicant address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei Province, China

Study leader's address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei Province, China

申请注册联系人邮政编码：

Applicant postcode：

 430074

研究负责人邮政编码：

Study leader's postcode：

 430074

申请人所在单位：

华中科技大学同济医学院附属协和医院

Applicant's institution：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究负责人所在单位：

华中科技大学同济医学院附属协和医院

Affiliation of the Leader：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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]伦审字(0325-01)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：

华中科技大学同济医学院附属协和医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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：

褚圆圆

Contact Name of the ethic committee：

Chu Yuanyuan

伦理委员会联系地址：

中国湖北省武汉市江汉区解放大道1277号

Contact Address of the ethic committee：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 8572 6375

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 whunionlunli@126.com

研究实施负责（组长）单位：

华中科技大学同济医学院附属协和医院

Primary sponsor：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究实施负责（组长）单位地址：

中国湖北省武汉市江汉区解放大道1277号

Primary sponsor's address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei Province, 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)：

湖北

市(区县)：

武汉

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

华中科技大学同济医学院附属协和医院

具体地址：

中国湖北省武汉市江汉区解放大道1277号

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei Province, China

经费或物资来源：

远大医药（中国）有限公司

Source(s) of funding：

Yuanda Pharmaceutical (China) Co., Ltd

研究疾病：

脓毒症  

Target disease：

Sepsis

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：

评估健康受试者单次/多次静脉给药GPN00068注射液的安全性与耐受性，以及体内药代动力学特征。  

Objectives of Study：

Evaluate the safety and tolerability of single/multiple intravenous administration of GPN00068 injection in healthy subjects, as well as its pharmacokinetic characteristics in vivo.

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. 受试者理解并遵守研究流程，自愿参加，并签署知情同意书； 2. 年龄为18~45周岁的健康成年受试者（包括边界值），男女均有； 3. 体重不超过80 kg。男性受试者体重不低于50 kg、女性受试者体重不低于45 kg。BMI＝体重（kg）/身高^2（kg/m^2），体重指数在18~26 kg/m^2范围内（包括边界值）； 4. 不酗酒，同意在试验期间禁烟和禁酒； 5. 从筛选期到给药结束后6个月无育儿计划且同意在研究期间采取有效措施避孕者，育龄妇女血妊娠试验阴性。

Inclusion criteria

1. Subjects understand and comply with the study procedures, voluntarily participate, and have signed the informed consent form; 2. Healthy adult subjects aged 18 to 45 years (inclusive), of either sex; 3. Body weight not exceeding 80 kg. Male subjects must weigh at least 50 kg, and female subjects at least 45 kg. BMI = body weight (kg) / height^2 (kg/m^2), with a body mass index within the range of 18 to 26 kg/m^2 (inclusive); 4. Non-alcoholic; agree to abstain from smoking and alcohol consumption during the study period; 5. Subjects with no intention to conceive from screening through 6 months after the last dose, and who agree to use effective contraceptive measures during the study; women of childbearing potential must have a negative serum pregnancy test.

排除标准：

1. 筛选前受试者存在有临床意义的下列疾病（包括但不限于胃肠道、肾、肝、神经、血液、内分泌、肿瘤、肺、免疫、精神或心脑血管疾病）； 2. 有长QT综合征家族史（祖父母、父母和兄弟姐妹）及筛选期QT间期延长者，如男性>=0.45秒，女性>=0.47秒； 3. 筛选前存在潜在影响试验用药品吸收、分布、代谢和排泄的胃肠道及肝脏、肾脏疾病史或手术史者，或者可能对受试者构成危害的任何病情； 4. 任何具有临床意义的体格检查、心电图或临床实验室结果； 5. 生命体征异常（收缩压<=90 mmHg或>=140 mmHg，舒张压>=90 mmHg或<=60 mmHg、脉搏<=55次/分或>=100次/分）； 6. 筛选期尿路梗阻或尿排空困难； 7. 有酗酒史（酗酒定义为：每周饮用14个单位的酒精：1单位=啤酒285 ml，或烈酒25 ml，或葡萄酒100 ml），或者在首次给药前48小时内服用过任何含酒精的制品，或者筛选期内酒精呼气试验阳性者； 8. 筛选前2年内有药物滥用史或使用过毒品者或筛选期内尿药筛查阳性者； 9. 筛选前3个月每日吸烟超过5支或自签署受试者知情同意至受试者出组期间不能放弃吸烟者； 10. 乙型肝炎表面抗原（HBsAg）、丙型肝炎病毒（HCV）抗体和/或人类免疫缺陷病毒（HIV）抗体、梅毒血清反应（TRUST）检查结果为阳性者； 11. 入组前4周内使用任何处方药，或者入组前2周内使用任何非处方药（包括维生素、中草药类补药等），或者入组前2周内服用过影响药物代谢酶的食物，比如西柚或含有西柚的饮料。可以使用对乙酰氨基酚，但必须记录在病历中； 12. 存在有临床意义的药物、食物过敏史或特应性变态反应性疾病史（哮喘、荨麻疹、湿疹性皮炎）； 13. 在筛选前3个月内献血或者作为受试者被采样者或大量失血者（>=400 ml）； 14. 在筛选前3个月内参加了其他临床试验（如果受试者在治疗前退出研究，即未被随机化或未接受治疗，可以入组本研究）； 15. 受试者正在哺乳或妊娠结果阳性，或近期有生育计划； 16. 采血困难，不能耐受静脉穿刺者，或有晕针、晕血史者； 17. 筛选前1个月内接种过疫苗者或在试验期内计划接种疫苗者； 18. 研究者认为具有其他不适宜参加本试验因素的受试者。

Exclusion criteria：

1. Subjects with clinically significant diseases prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular diseases); 2. Subjects with a family history of long QT syndrome (in grandparents, parents, or siblings) or prolonged QT interval during screening (male >= 0.45 sec, female >= 0.47 sec); 3. Subjects with a history of gastrointestinal, hepatic, or renal diseases or surgeries prior to screening that may potentially affect the absorption, distribution, metabolism, or excretion of the investigational product, or any condition that may pose a risk to the subject; 4. Any clinically significant findings from physical examination, electrocardiogram (ECG), or clinical laboratory tests; 5. Abnormal vital signs (systolic blood pressure <= 90 mmHg or >= 140 mmHg, diastolic blood pressure >= 90 mmHg or <= 60 mmHg, pulse rate <= 55 bpm or >= 100 bpm); 6. Urinary tract obstruction or difficulty with urinary emptying during screening; 7. Subjects with a history of alcohol abuse (defined as consumption of 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine), or consumption of any alcoholic product within 48 hours prior to first dosing, or a positive breath alcohol test during screening; 8. Subjects with a history of drug abuse or use of illicit drugs within the past 2 years, or a positive urine drug screen during screening; 9. Subjects who smoked more than 5 cigarettes per day within the past 3 months, or who are unable to abstain from smoking from the time of signing the informed consent until study completion; 10. Subjects with positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and/or human immunodeficiency virus (HIV) antibody, or syphilis serology (TRUST); 11. Subjects who used any prescription medication within 4 weeks prior to enrollment, or any over-the-counter medication (including vitamins, herbal supplements, etc.) within 2 weeks prior to enrollment, or consumed foods affecting drug-metabolizing enzymes (e.g., grapefruit or grapefruit-containing beverages) within 2 weeks prior to enrollment. Acetaminophen may be used but must be documented in the medical record; 12. Subjects with a clinically significant history of drug or food allergy or atopic allergic disorders (e.g., asthma, urticaria, eczematous dermatitis); 13. Subjects who donated blood, participated as a subject in blood sampling, or experienced significant blood loss (>= 400 mL) within the past 3 months; 14. Subjects who participated in another clinical trial within the past 3 months (subjects who withdrew from a prior study prior to randomization or treatment may be enrolled in this study); 15. Subjects who are breastfeeding, have a positive pregnancy test, or have plans to conceive in the near future; 16. Subjects with difficulty with venipuncture, intolerance to needle insertion, or a history of syncope related to needles or blood; 17. Subjects who received any vaccination within the past month or who plan to receive a vaccination during the trial period; 18. Subjects whom the investigator considers to have other factors making them unsuitable for participation in this trial.

研究实施时间：

Study execute time：

从 From 2023-07-09 00:00:00至 To 2024-12-25 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-08-03 00:00:00 至 To 2023-11-08 00:00:00

干预措施：

Interventions：

组别：

单次给药剂量递增组

样本量：

 36

Group：

Single dose increasing group

Sample size：

干预措施：

单次静脉注射GPN00068。 小剂量：0.01 mg/kg，0.04 mg/kg 用法：GPN00068 注射液静脉推注（30 秒内），单次给药。 正常剂量组：0.08 mg/kg，0.16 mg/kg，0.24 mg/kg，0.36 mg/kg，0.54 mg/kg 用法：GPN00068 注射液输注，输注速度150 mL/h，输注时间30 min 内，单次给药。 第 1 和 2 剂量组每例受试者间隔至少 1 h 给药，以保证受试者的安全。第 3~7 剂量组给药采取哨兵法原则，每个剂量组先随机入组 2 例受试者给予试验药或安慰剂。研究者根据哨兵的（不少于 48 小时）安全性观察结果，决定是否开展该剂量组剩余受试者的随机给药。 单次剂量递增试验预计 7 个剂量组，0.01 mg/kg、0.04 mg/kg 剂量组各入组 4 例（3 例接受试验药物，1 例接受安慰剂），其他剂量组各入组 8 例（6 例接受试验药物，2 例接受安慰剂）

干预措施代码：

Intervention：

Single intravenous administration of GPN00068. Low doses: 0.01 mg/kg, 0.04 mg/kg Administration: GPN00068 injection administered by intravenous bolus injection (within 30 seconds), single dose only. Therapeutic dose groups: 0.08 mg/kg, 0.16 mg/kg, 0.24 mg/kg, 0.36 mg/kg, 0.54 mg/kg Administration: GPN00068 injection administered via intravenous infusion at a rate of 150 mL/h, completed within 30 minutes, single dose only. For Dose Groups 1 and 2, each subject must be dosed at least 1 hour apart to ensure subject safety. For Dose Groups 3 through 7, a sentinel dosing strategy will be employed: initially, two subjects per dose group will be randomized to receive either the investigational product or placebo. The investigator will evaluate the safety data (for at least 48 hours) from these sentinel subjects before deciding whether to proceed with randomization and dosing of the remaining subjects in that dose group. The single ascending-dose study is planned to include seven dose groups: Dose groups 0.01 mg/kg and 0.04 mg/kg: 4 subjects each (3 receiving investigational drug, 1 receiving placebo). All other dose groups (0.08, 0.16, 0.24, 0.36, and 0.54 mg/kg): 8 subjects each (6 receiving investigational drug, 2 receiving placebo).

Intervention code：

组别：

多次给药剂量递增组

样本量：

 27

Group：

Multiple dose escalation group

Sample size：

干预措施：

多次静脉注射GPN00068。用法：静脉输注，各剂量组给药方法如下： 剂量：0.08 mg/kg，0.16 mg/kg，0.32 mg/kg 给药：GPN00068 注射液静脉输注，输注时间30 min 内，每12 h（+/-0.5 h）给药一次，连续给药5 天，第五天仅早上给药一次。 多次剂量递增试验预计 3 个剂量组，0.08 mg/kg、0.16 mg/kg、0.32 mg/kg 各入组 12 例（9 例接受试验药物，3 例接受安慰剂）

干预措施代码：

Intervention：

Multiple intravenous administrations of GPN00068. Administration: GPN00068 injection administered via intravenous infusion over 30 minutes, dosed every 12 hours (+/-0.5 hours), for a total of 5 consecutive days. On day 5, only a single morning dose is administered. The multiple ascending-dose study is expected to include 3 dose levels: 0.08 mg/kg, 0.16 mg/kg, and 0.32 mg/kg. Each dose group will enroll 12 subjects (9 receiving the investigational drug and 3 receiving placebo).

Intervention code：

组别：

安慰剂组

样本量：

 21

Group：

Placebo group

Sample size：

干预措施：

静脉注射安慰剂

干预措施代码：

Intervention：

Intravenous injection of placebo

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

 武汉 

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

 华中科技大学同济医学院附属协和医院 

单位级别：

 三甲 

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

SAD 血药代动力学 PK 参数：AUC0-∞、AUC0-t、Cmax、Tmax、 t1/2z、λz、CLz、Vz、AUC_%Extrap、MRT 等。

指标类型：

主要指标

Outcome：

SAD pharmacokinetic (PK) parameters: AUC?–∞, AUC?–t, Cmax, Tmax, t?/?z, λz, CLz, Vz, AUC_%Extrap, MRT, etc.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

SAD 尿药代动力学 PK 参数：Ae、Fe、CLR

指标类型：

主要指标

Outcome：

SAD urinary pharmacokinetic (PK) parameters: Ae, Fe, CLR

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

MAD 药代动力学 PK 参数：AUC0-∞、AUC0-t、Cmax,ss、Tmax、 t1/2z、λz、CLss、Vz、MRT、AUC_%Extrap、Cmin,ss、Cmax,ss、Cav,ss、 Swing、 Ctrough,ss、 AUC0-τ,ss 及稳态波动系数（ DF）、蓄积比率 等。

指标类型：

主要指标

Outcome：

MAD pharmacokinetic (PK) parameters: AUC?–∞, AUC?–t, Cmax,ss, Tmax, t?/?z, λz, CLss, Vz, MRT, AUC_%Extrap, Cmin,ss, Cmax,ss, Cav,ss, Swing, Ctrough,ss, AUC?–τ,ss, fluctuation coefficient at steady state (DF), and accumulation ratio.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安全性与耐受性评估：不良事件、实验室检查（血常规、凝血功能、尿常规、血生化、肾脏B超等）、生命体征（坐位血压、脉搏和体温）、体格检查、心电图检查、注射部位反应，以及仅在SAD中进行的类过敏指标检测、肾脏损伤早期指标检测和IL-6检测。

指标类型：

副作用指标

Outcome：

Safety and Tolerability Assessment: Adverse events, laboratory tests (complete blood count, coagulation function, urinalysis, serum biochemistry, renal ultrasound, etc.), vital signs (supine blood pressure, pulse, and temperature), physical examination, electrocardiogram (ECG), injection site reactions, as well as allergenicity markers, early indicators of renal injury, and IL-6 detection (conducted only in SAD).

Type：

Adverse events

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 45 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）：

本试验单次和多次给药为随机、双盲、安慰剂对照、剂量递增设计，均采用区组随机化方法，每个剂量组分别随机，由统计单位采用SAS（9.4 或更高版本）软件生成随机号及其对应的组别（试验药或安慰剂）。受试者筛选合格之后按照筛选号从小到大获得随机号。随机化过程中所设定的区组长度、种子数和SAS程序将一同保存记录，以保证该随机号编码具有可重现性。 单次给药筛选号命名规则为A+S+三位编号，如 AS001、AS002，以此类推。多次给药筛选号命名规则为B+S+三位编号，如BS001、BS002，以此类推。 单次给药随机号名称规则为A+四位数组成，第一位数代表为剂量组号，后三位数代表组内顺序号，如第一个剂量组随机号为A1001到A1004，第二个剂量组随机号为A2001到A2004，以此类推。多次给药随机号名称规则同单次给药，将A换成B。 受试者在给药前退出试验，可以采用筛选合格但未入组的同性别受试者进行替补，替补受试者随机号+100，即A2101 将替补A2001，替补受试者接受和被替补受试者相同的研究干预措施。

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

This trial is a randomized, double-blind, placebo-controlled, dose escalation design for single and multiple doses, using block randomization. Each dose group is randomized separately, and the statistical unit generates a random number and its corresponding group (experimental drug or placebo) using SAS (version 9.4 or higher) software. After the subjects pass the screening, random numbers are obtained from the screening number in ascending order. The block length, seed number, and SAS program set during the randomization process will be recorded together to ensure the reproducibility of the random number encoding. The naming convention for single dose screening numbers is A+S+three digit numbers, such as AS001 AS002, and so on. The naming convention for multiple administration screening numbers is B+S+three digit numbers, such as BS001 BS002, and so on. The naming convention for single dose random numbers is composed of A+four digits, with the first digit representing the dose group number and the last three digits representing the sequence number within the group. For example, the first dose group random number is A1001 to A1004, the second dose group random number is A2001 to A2004, and so on. The random number name rule for multiple doses is the same as for a single dose, replace A with B. If a subject withdraws from the trial before administration, a qualified but non enrolled subject of the same gender can be used as a substitute. The substitute subject will have a random number of+100, i.e. A2101 will replace A2001. The substitute subject will receive the same research intervention measures as the substitute subject.

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：

相应规格试验药物与其模拟剂（安慰剂）在外观、重量、标签、包装以及给药数量等方面相同，以确保盲法的实施。 随机号即作为药物盲法实施的药物号，同时为替补受试者准备完全相同的一份药物，备用药物号采用原药物号+100。药物现场编盲由统计单位（独立编盲人员）和申办单位与本试验无关人员参加，将已形成的随机号（药物号）填写（或粘贴）在标签上。编盲过程形成编盲记录保存。

Blinding：

The corresponding specifications of the investigational drug and its analog (placebo) are identical in appearance, weight, labeling, packaging, and dosage to ensure the implementation of blinding. The random number is used as the drug number for implementing drug blinding, and an identical drug is prepared for the substitute subjects. The backup drug number is the original drug number plus 100. The on-site blinding of drugs shall be conducted by the statistical unit (independent blinding personnel) and the applicant unit, and personnel unrelated to this trial shall participate. The generated random number (drug number) shall be filled in (or pasted) on the label. The process of blind coding forms blind coding records for preservation.

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）：

研究结束半年；国家生物信息中心(https://ngdc.cncb.ac.cn/gsub/)

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

Six months after the study completion; National Bioinformation Center (https://ngdc.cncb.ac.cn/gsub/)

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：

数据采集：eCRF 数据来源于原始记录，由数据录入人员根据eCRF 填写说明，将受试者访视数据及时录入 EDC。 数据管理：本项目以NMPA颁布的《临床试验数据管理工作技术指南》、《药物临床试验数据管理与统计分析的计划和报告指导原则》、《临床试验的电子数据采集技术指导原则》中的要求为基本依据进行数据管理。

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

Data collection: eCRF data comes from raw records, and the data entry personnel fill in the instructions according to eCRF to timely enter the subject visit data into EDC. Data Management: This project is based on the requirements of the "Technical Guidelines for Clinical Trial Data Management", "Guidelines for Planning and Reporting of Drug Clinical Trial Data Management and Statistical Analysis", and "Technical Guidelines for Electronic Data Collection of Clinical Trials" issued by NMPA for data management.

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 12:48:25