ChiCTR2500106384 版本V1.0 版本创建时间2025/07/23 09:36:15 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：

 ChiCTR2500106384 

最近更新日期：

Date of Last Refreshed on：

 2025-07-23 09:35:42 

注册时间：

Date of Registration：

 2025-07-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价IMBZ18g在中国健康受试者中安全性、耐受性和药代动力学特征的单中心、随机、双盲、安慰剂对照、单次给药和多次给药剂量递增的I期临床研究

Public title：

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Administration and Multiple-Administration Dose Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of IMBZ18g in Healthy Chinese Subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价IMBZ18g在中国健康受试者中的单中心、随机、双盲、安慰剂对照、单次给药和多次给药剂量递增的I期临床研究

Scientific title：

Evaluation of a single center, randomized, double-blind, placebo-controlled, single dose, and multiple dose escalation phase I clinical study of IMBZ18g in Chinese 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：

姚柳端 

研究负责人：

李昕 

Applicant：

YAO Liuduan  

Study leader：

LI Xin 

申请注册联系人电话：

Applicant telephone：

 +86 135 7052 0006

研究负责人电话：

Study leader's
telephone：

+86 731 8617 1383

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：

 yaoliuduan@gzhc.com.cn

研究负责人电子邮件：

Study leader's E-mail：

 xin-li@cssdsyy.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：

广州市黄埔区神舟路288号D栋312房

研究负责人通讯地址：

湖南省-长沙市-天心区劳动西路176号

Applicant address：

Room 312, Building D, Shenzhou Road No.288, Huangpu District, Guangzhou

Study leader's address：

No. 176 Laodong West Road, Tianxin District, Changsha, Hunan

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：

广州艾奇西新药研究有限公司

Applicant's institution：

Guangzhou HC New Drug Research Co., Ltd.

研究负责人所在单位：

长沙市第三医院

Affiliation of the Leader：

The Third Hospital of Changsha

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：

 CS3-会2025EC-030; CS3-快2025EC-069

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：

长沙市第三医院伦理委员会

Name of the ethic committee：

Changsha Third Hospital Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-29 00:00:00

伦理委员会联系人：

廖彩秀

Contact Name of the ethic committee：

Liao Caixiu

伦理委员会联系地址：

长沙市天心区劳动西路176号

Contact Address of the ethic committee：

No. 176 Laodong West Road, Tianxin District, Changsha, Hunan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 8517 1314

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 cssdsyyllwyh@163.com

研究实施负责（组长）单位：

长沙市第三医院

Primary sponsor：

The Third Hospital of Changsha

研究实施负责（组长）单位地址：

长沙市天心区劳动西路176号

Primary sponsor's address：

No. 176 Laodong West Road, Tianxin District, Changsha, Hunan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

Country：

China

Province：

Hunan

City：

单位(医院)：

长沙市第三医院

具体地址：

长沙市天心区劳动西路176号

Institution
hospital：

The Third Hospital of Changsha

Address：

No. 176 Laodong West Road, Tianxin District, Changsha, Hunan

经费或物资来源：

广州艾奇西新药研究有限公司

Source(s) of funding：

Guangzhou HC New Drug Research Co., Ltd.

研究疾病：

健康人  

Target disease：

healthy subjects

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：

主要目的： ?评价中国健康受试者接受单次和多次IMBZ18g给药后的安全性和耐受性。 次要目的： ?评估中国健康受试者接受单次和多次IMBZ18g给药后的药代动力（Pharmacokinetics，PK）特征； ?确定II期推荐给药剂量（Recommended Phase II Dose，RP2D）； ?评价中国健康受试者接受单次IMBZ18g给药后对QT间期的影响。  

Objectives of Study：

Main purpose: Evaluate the safety and tolerability of single and multiple administration of IMBZ18g in Chinese healthy subjects. Secondary purpose: Evaluate the pharmacokinetic (PK) characteristics of Chinese healthy subjects after single and multiple administration of IMBZ18g; Determine the Recommended Phase II Dose (RP2D) for Phase II administration; Evaluate the effect of single administration of IMBZ18g on QT interval in Chinese healthy 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：

受试者必须符合下述所有标准方可纳入研究： 1.年龄在18~45周岁（含18和45周岁）的中国志愿者，男女兼可； 2.男性志愿者体重不小于50 kg，女性志愿者体重不小于45 kg；体重指数在19~26范围内（包括临界值）。体重指数（BMI）＝体重（kg）/身高^2（m^2）； 3.试验前签署知情同意书、并对试验内容、过程及可能出现的不良反应充分了解； 4.志愿者能够和研究者进行良好的沟通，并且理解和遵守本项研究的各项要求者。

Inclusion criteria

Subjects must meet all of the following criteria to be included in the study: 1. Chinese volunteers aged 18 to 45 years old (inclusive), both male and female; 2. The weight of male volunteers should not be less than 50 kg, and the weight of female volunteers should not be less than 45 kg; the body mass index should be within the range of 19-26 (including the critical value). Body Mass Index (BMI)=Weight (kg)/Height ^2 (m ^2) ; 3. Sign the informed consent form before the trial and fully understand the trial content, process and possible adverse reactions; 4. Volunteers are able to communicate effectively with researchers and understand and comply with the requirements of this study.

排除标准：

如果受试者满足下列任何1条标准，则将其从研究中排除： 1.使用研究药物前3个月内参加了任何药物临床试验者且使用研究药物者； 2.有呼吸系统、心血管系统、内分泌系统、泌尿系统、神经系统、血液学、免疫学（包括个人或家族史遗传性免疫缺陷）、代谢异常等病史且研究者认为目前仍有临床意义者； 3.对青霉素和头孢菌素过敏者，或对本药物任何一种成分过敏，或有药物、食物或其他物质过敏史者，或过敏体质者； 4.存在肝脏或肾脏疾病，或其他已知会干扰药物的吸收、分布、代谢或排泄的状况，或者存在这些疾病的后遗症者； 5.有艰难梭菌相关性腹泻者； 6.使用研究药物前30天内使用过任何影响研究药物吸收代谢的药物，经研究者判断不宜参加试验者； 7.使用研究药物前14天内使用过任何药物者（包括中草药、保健品等）； 8.使用研究药物前6个月内接受过经研究者判断会影响药物吸收、分布、代谢、排泄的手术者；或使用研究药物前4周内接受过外科手术；或计划在试验期间进行外科手术者； 9.筛选时根据CockcroftGault公式计算的肌酐清除率≤80 mL/min； 10.体格检查、心电图、生命体征、实验室检查（输血四项、血生化、血常规、凝血功能、尿常规）各项检查异常有临床意义者（以临床医师判断为准）； 11.使用研究药物前3个月内献血或大量失血（＞400mL）者，接受输血或使用血制品者，或打算在试验期间或试验结束后3个月内献血或血液成份者； 12.酗酒者或使用研究药物前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位=360 mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒）；或试验期间不愿意停止饮酒或任何含酒精的制品； 13.药物滥用者或使用研究药物前1年内使用过软毒品（如：大麻）或硬毒品（如：可卡因、苯环己哌啶等）者； 14.嗜烟者或使用研究药物前3个月每日吸烟量多于5支者，或试验期间不能停止使用任何烟草类产品； 15.每天饮用过量茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯=250 mL）者，或不同意试验期间停止饮用茶、咖啡和/或含咖啡因的饮料者； 16.使用研究药物前7天内进食可能影响药物体内代谢的饮食（包括葡萄柚或葡萄柚产品、火龙果、芒果、柚子、橘子等），或研究者认为有其他影响药物吸收、分布、代谢、排泄的饮食者，或不同意试验期间停止进食上述饮食者； 17.酒精呼气试验阳性者； 18.尿毒筛试验阳性者； 19.对饮食有特殊要求，不能遵守统一饮食者； 20.不能耐受静脉穿剌或有晕血、晕针史者； 21.志愿者（或其伴侣）试验期间至试验结束后3个月内有妊娠计划、捐精捐卵计划，或不愿采取一种或一种以上的非药物避孕措施（如完全禁欲、避孕套、避孕环、伴侣结扎等）者； 22.女性志愿者为妊娠或哺乳期女性；或在使用研究药物前2周内发生非保护性性行为者；或使用研究药物前30天内使用口服避孕药或使用研究药物前6个月内使用长效雌激素或孕激素注射剂或埋植片者； 23.使用研究药物前14天内接种疫苗或减毒活疫苗，或计划会在试验期间接种疫苗者； 24.志愿者可能因为其他原因而不能完成本研究或经研究者判断具有其它不宜参加试验原因者。

Exclusion criteria：

If a subject meets any of the following criteria, they will be excluded from the study: 1.Individuals who have participated in any clinical trial of the investigational drug within the past 3 months and have used the investigational drug; 2.Individuals with a history of respiratory system, cardiovascular system, endocrine system, urinary system, nervous system, hematology, immunology (including personal or family history of hereditary immunodeficiency), metabolic abnormalities, etc., who are still clinically significant according to the researchers; 3.Individuals who are allergic to penicillin and cephalosporins, or to any component of this drug, or have a history of allergies to drugs, food, or other substances, or have an allergic constitution; 4.Individuals with liver or kidney diseases, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or with sequelae of these diseases; 5.Individuals with Clostridium difficile associated diarrhea; 6.Individuals who have used any drugs that affect the absorption and metabolism of the investigational drug within 30 days prior to its use, and have been deemed unsuitable by the researcher to participate in the trial; 7.Individuals who have used any medication (including traditional Chinese herbs, health supplements, etc.) within the 14 days prior to using the research drug; 8.Those who have undergone surgery that the researcher judged would affect drug absorption, distribution, metabolism, and excretion within 6 months before using the study drug; or those who have undergone surgery within 4 weeks before using the study drug; or those who plan to undergo surgery during the trial; 9.Creatinine clearance calculated according to the Cockcroft-Gault formula at screening ≤ 80 mL/min; 10.Those with clinically significant abnormalities in physical examination, electrocardiogram, vital signs, laboratory tests (four blood transfusions, blood biochemistry, blood routine, coagulation function, urine routine) (subject to the judgment of clinical physicians); 11.Those who donated blood or lost a large amount of blood (>400 mL) within 3 months before using the study drug, received blood transfusion or used blood products, or planned to donate blood or blood components during the trial or within 3 months after the end of the trial; 12.Alcoholics or regular drinkers within 6 months before using the study drug, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of 40% alcohol liquor or 150 mL wine); or unwilling to stop drinking or any alcoholic products during the trial; 13.Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before using the study drug; 14.Smokers or those who smoke more than 5 cigarettes a day in the 3 months before using the study drug, or cannot stop using any tobacco products during the trial; 15.Those who drink excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day, or those who do not agree to stop drinking tea, coffee and/or caffeinated beverages during the trial; 16.Those who have consumed food that may affect the metabolism of the drug in the body (including grapefruit or grapefruit products, pitaya, mango, pomelo, orange, etc.) within 7 days before the use of the study drug, or those who the researchers believe have other foods that affect the absorption, distribution, metabolism, and excretion of the drug, or those who do not agree to stop eating the above foods during the trial; 17.Those who have a positive alcohol breath test; 18.Those who have a positive urine drug screening test; 19.Those who have special requirements for diet and cannot follow a unified diet; 20.Those who cannot tolerate intravenous puncture or have a history of blood or needle phobia; 21.Volunteers (or their partners) have plans to become pregnant or donate sperm and eggs during the trial and within 3 months after the end of the trial, or are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, contraceptive rings, partner sterilization, etc.); 22.Female volunteers are pregnant or breastfeeding women; or have had unprotected sex within 2 weeks before using the study drug; or have used oral contraceptives within 30 days before using the study drug, or have used long-acting estrogen or progesterone injections or implants within 6 months before using the study drug; 23.Have received a vaccine or live attenuated vaccine within 14 days before using the study drug, or plan to receive a vaccine during the trial; 24.Volunteers may not be able to complete this study for other reasons or have other reasons that the researcher determines are not suitable for participating in the trial.

研究实施时间：

Study execute time：

从 From 2025-07-23 00:00:00至 To 2026-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-07-25 00:00:00 至 To 2025-12-30 00:00:00

干预措施：

Interventions：

组别：

SAD阶段IMBZ18g组

样本量：

 32

Group：

SAD stage IMBZ18g group

Sample size：

干预措施：

6个剂量组（100 mg、250 mg、500 mg、1000 mg、2000 mg和3000 mg）空腹条件下静脉滴注给药

干预措施代码：

Intervention：

Six dose groups (100mg,250mg,500mg,1000mg,2000mg and 3000mg) will perform intravenous infusion of administration on an empty stomach.

Intervention code：

组别：

SAD阶段安慰剂组

样本量：

 10

Group：

SAD stage placebo group

Sample size：

干预措施：

5个剂量组（250 mg、500 mg、1000 mg、2000 mg和3000 mg）空腹条件下静脉滴注生理盐水

干预措施代码：

Intervention：

Five dose groups (250mg,500mg,1000mg,2000mg and 3000mg) will perform intravenous infusion of physiological saline on an empty stomach.solution

Intervention code：

组别：

MAD阶段IMBZ18g组

样本量：

 18

Group：

MAD stage IMBZ18g group

Sample size：

干预措施：

3个剂量组（500 mg、1000 mg 和 2000 mg）空腹条件下静脉滴注给药

干预措施代码：

Intervention：

There dose groups (500mg,1000mg and 2000mg ) will perform intravenous infusion of administration on an empty stomach.

Intervention code：

组别：

MAD阶段安慰剂组

样本量：

 6

Group：

MAD stage placebo group

Sample size：

干预措施：

3个剂量组（500 mg、1000 mg 和 2000 mg）空腹条件下静脉滴注生理盐水

干预措施代码：

Intervention：

There dose groups (500mg,1000mg and 2000mg ) will perform intravenous infusion of physiological saline on an empty stomach.solution

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China

Province：

Hunan

City：

单位(医院)：

 长沙市第三医院 

单位级别：

 三甲 

Institution
hospital：

The Third Hospital of Changsha

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：

实验室评价（血常规、血生化、尿常规、凝血功能）

指标类型：

主要指标

Outcome：

Laboratory evaluation (blood routine, blood biochemistry, urine routine, coagulation function)

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（ECG）

指标类型：

主要指标

Outcome：

12 lead electrocardiogram (ECG)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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：

注射部位反应

指标类型：

主要指标

Outcome：

Injection site reaction

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

单次给药PK参数

指标类型：

次要指标

Outcome：

Single dose PK 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：

多次给药PK参数

指标类型：

次要指标

Outcome：

multiple dose PK parameters

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：

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：

尚未开始

Not yet recruiting

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）：

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或更高版本的PLAN过程，用区组随机法生成受试者随机表。为确保该随机数据具有重现性，需要保存所设定的随机数种子参数。

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

The random number of the subjects was generated by an independent statistician using block randomization method, and the independent statistician used SAS v9.4 or higher version PLAN process to generate the subject randomization table using block randomization method. To ensure the reproducibility of the random data, it is necessary to save the set random number seed parameters.

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：

本试验为双盲研究。对试验用药品分配处于盲态的人员包括：申办者、研究者、受试者。对试验用药品分配处于非盲态的人员包括制作随机表和破盲信封的统计师、药品仓储供应商管理人员进行 PK血样分析的生物分析实验室人员、药品配置研究者以及为研究者和申办者进行中期 PK 分析的药代动力学家。

Blinding：

This experiment is a double-blind study. The personnel who are blinded in the allocation of experimental drugs include: sponsors, researchers, and subjects. The personnel responsible for non blinded allocation of experimental drugs include statisticians who create randomization tables and unblinded envelopes, bioanalytical laboratory personnel who conduct PK blood sample analysis for drug storage supplier management, drug configuration researchers, and pharmacokinetic experts who conduct mid-term PK analysis for researchers and sponsors. Blind safety and PK data will be provided to researchers and sponsors; Hide the random number or provide a simulated random number to researchers and sponsors by non blinded pharmacokinetic experts to avoid disclosing the treatment allocation plan.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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)：

none

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：

研究者应当确保所有临床试验数据是从临床试验的源文件和试验记录中获得的，是准确、完整、可读和及时的。源数据必须保持可归因性、易读性、同时性、原始性、准确性、完整性、一致性和持久性。研究者须按照法规要求保存原始数据。源数据的修改应当留痕，不能掩盖初始数据，并记录修改的理由。临床试验中所使用的过的计算机化系统应当具有完善的权限管理和稽查轨迹，可以追溯至记录的创建者或者修改者，保障所采集的源数据可以溯源。 原始病历的记录需完整、清晰。对数据的更正需注明原因、修改人、修改日期，并保留修改痕迹。 本试验数据管理由申办单位指定的数据管理部门负责，本试验使用电子数据采集（Electronic Data Capture，EDC）系统。根据数据管理计划（Data Management Plan，DMP）和数据核查说明（Data Verification Specification，DVS）对系统数据进行管理和核查。 数据管理部门根据方案设计eCRF。研究者或者研究者指定人员根据原始数据准确、完整、及时地填写eCRF。数据管理员对录入EDC系统的数据进行逻辑核查和人工核查，保证数据的准确性。数据管理过程中应保存所有的稽查轨迹。数据管理员对疑问数据提出质疑，所有质疑得到解决，研究者对每一份eCRF中进行电子签名确认。申办单位负责人、研究者、数据管理人员和统计分析师在盲态下共同审核数据。最终数据库锁定，对文件进行归档。锁定的数据库一般不得解锁，如需解锁时，提交申请由主要研究者、数据管理人员和统计分析师等人员共同签署。数据库的再次锁定应遵循和数据库首次锁定一样的通知/批准过程。

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

Researchers should ensure that all clinical trial data is obtained from the source files and trial records of clinical trials, and is accurate, complete, readable, and timely. The source data must maintain traceability, readability, simultaneity, originality, accuracy, completeness, consistency, and persistence. Researchers must preserve raw data in accordance with regulatory requirements. The modification of source data should leave a trace, not cover up the initial data, and record the reasons for the modification. The computerized systems used in clinical trials should have complete permission management and audit trajectories, which can be traced back to the creator or modifier of the records, ensuring that the collected source data can be traced back. The original medical records must be complete and clear. The correction of data should indicate the reason, modifier, modification date, and retain the traces of modification. The data management of this experiment is the responsibility of the data management department designated by the sponsor, and this experiment uses an Electronic Data Capture (EDC) system. Manage and verify system data according to the Data Management Plan (DMP) and Data Verification Specification (DVS). The data management department designs eCRF according to the plan. Researchers or designated personnel shall accurately, completely, and timely fill in eCRF based on the original data. The data administrator conducts logical and manual checks on the data entered into the EDC system to ensure its accuracy. All audit trajectories should be saved during the data management process. The data administrator raised doubts about the questionable data, and all doubts were resolved. The researchers conducted electronic signature confirmation on each eCRF. The head of the applicant, researchers, data management personnel, and statistical analysts jointly review the data in a blinded manner. Finally, the database is locked and the files are archived. Locked databases generally cannot be unlocked. If unlocking is required, an application must be submitted and signed jointly by the main researcher, data management personnel, and statistical analysts. The re locking of the database should follow the same notification/approval process as the initial locking of the database.

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：

  2025-07-23 09:35:42