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单次皮下给予阿巴西普的PK、安全性、耐受性研究
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注册号:

Registration number:

ChiCTR-IIR-16008693 

最近更新日期:

Date of Last Refreshed on:

2016-06-23 

注册时间:

Date of Registration:

2016-06-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

单次皮下给予阿巴西普的PK、安全性、耐受性研究 

Public title:

Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

在中国健康受试者中评估单次皮下给予阿巴西普125mg的药代动力学、安全性、耐受性的随机、双盲、安慰剂对照的I期临床试验 

Scientific title:

A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously 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:

胡爽 

研究负责人:

丁艳华 

Applicant:

Shuanghu 

Study leader:

Yanhua Ding 

申请注册联系人电话:

Applicant telephone:

+86 25 8556 0000-1826 

研究负责人电话:

Study leader's telephone:

+86 431 88782168 

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:

hushuang@simcere.com 

研究负责人电子邮件:

Study leader's E-mail:

dingyanhua2003@126.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:

江苏省南京市玄武区玄武大道699号-18 

研究负责人通讯地址:

吉林省长春市新民大街71号 

Applicant address:

699-18 Xuanwu Avenue, Xuanwu District, Nanjing, Jiangsu, China 

Study leader's address:

71 Xinmin Street, Changchun, Jilin, 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:

江苏先声药业有限公司 

Applicant's institution:

Jiangsu Simcere Pharmaceutical R&D Co. Ltd 

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:

2016-160427-061 

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:

吉林大学第一医院伦理委员会 

Name of the ethic committee:

IRB of The First Hospital, Jilin University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-04-27 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

吉林大学第一医院 

Primary sponsor:

The First Hospital, Jilin University 

研究实施负责(组长)单位地址:

吉林省长春市新民大街71号 

Primary sponsor's address:

71 Xinmin Street, Changchun, Jilin, 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):

吉林

市(区县):

长春

Country:

China

Province:

Jilin

City:

Changchun

单位(医院):

吉林大学第一医院

具体地址:

吉林省长春市新民大街71号

Institution
hospital:

The First Hospital, Jilin University

Address:

71 Xinmin Street, Changchun, Jilin, China

经费或物资来源:

江苏先声药业有限公司 

Source(s) of funding:

Jiangsu Simcere Pharmaceutical R&D Co. Ltd 

研究疾病:

类风湿关节炎 

Target disease:

Rheumatoid Arthritis 

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:

研究目的:

评价在中国健康受试者中单次皮下给予阿巴西普125 mg的药代动力学特征、安全性、耐受性及免疫原性 

Objectives of Study:

To assess the single dose PK, safety, tolerability and immunogenicity of abatacept 125mg administered SC in Chinese healthy subjects 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)受试者自愿参加研究并签署知情同意书;(2)健康受试者,健康的定义为在病史、体格检查、心电图检查及实验室检查方面与正常值无临床意义的偏差;(3)男性受试者的体重须大于50 kg,女性受试者的体重须大于45kg,且所有受试者体重均须小于100 kg,包括边界值;(4)体重指数(BMI)在19-26 kg/m2之间,包括边界值;(5)男性或女性受试者,18-45岁之间(包括边界值);(6)育龄期女性在整个研究期间,给药前4周及给药后10周必须采用可靠的避孕方式以避免妊娠,有生育能力男性受试者也需在研究期间及给药后10周内采取可靠的避孕方式避免其性伴侣怀孕;(7)育龄期女性在给药前24小时内的血妊娠试验须为阴性。 

Inclusion criteria

(1) Subjects are willing to participate in this study and signed informed consent; (2) Healthy subjects, as determined by no clinically significant deviation from normal in medical history, physical examination, Electrocardiograph(ECG), and clinical laboratory determinations; (3) Body weight for male must be>=50 kg, for female be>=45 kg, and all subjects must be <=100kg; (4) Body mass index (BMI) is 19-26 kg/m2 (boundary value included); (5) Men and women 18-45 years old (boundary value included); (6) Women of child bearing potential (WOCBP) must be using the adequate method of contraception to avoid pregnancy throughout the study, for 4 weeks before and for up to 10 weeks after administration of abatacept, male subjects of childbearing potential must be using an adequate method of contraception throughout the study and for up to 10 weeks after administration of investigational product in such a manner that risk of pregnancy is minimized; (7) WOCBP must have a negative serum pregnancy test within 24 hours prior to study medication administration. 

排除标准:

(1)女性怀孕或在哺乳期;(2)有中枢神经系统、心血管系统、肝肾功能不全、消化道系统、呼吸系统、代谢及骨骼系统疾病(包括但不限于:心律失常、心动过缓、低血压、冠心病、支气管哮喘、糖尿病、甲状腺功能亢进、帕金森病、癫痫、震颤麻痹、恶性肿瘤等),或其他任何可能影响研究结果的疾病及生理条件者;(3)入组前3个月内参加了任何药物临床试验,或在研究期间计划参加其他药物临床研究者;(4)先前曾使用过阿巴西普(CTLA4-Ig)、belatacept(LEA29Y)或任何白细胞消耗剂者;(5)其他排除标准。 

Exclusion criteria:

(1) Women who are pregnant or breast-feeding; (2) History or concurrent diseases of central nervous system, cardiovascular system, renal, hepatic, digestive tract, respiratory system, metabolism and musculoskeletal system. (including but not limited to arrhythmia, bradycardia, hypotension, coronary heart disease, bronchial asthma, diabetes, hyperthyroidism, Parkinson's disease, epilepsy, shaking palsy, cancer, etc.). Or any other diseases or physiological abnormalities, which might affect study results; (3) Exposed to any investigational medication within 3 months of enrollment, or plan to receive other investigational medication during the study; (4) Prior exposure to abatacept (CTLA4-Ig), belatacept (LEA29Y) or any leukocyte depleting agent; (5) Other exclusion criteria. 

研究实施时间:

Study execute time:

From2016-04-27To 2017-01-31 

征募观察对象时间:

Recruiting time:

From2016-08-20To 2016-11-20 

干预措施:

Interventions:

组别:

阿巴西普组

样本量:

20

Group:

Abatacept Group

Sample size:

干预措施:

阿巴西普单次给药

干预措施代码:

Intervention:

Single dose of abatacept

Intervention code:

组别:

安慰剂组

样本量:

2

Group:

Placebo Group

Sample size:

干预措施:

安慰剂单次给药

干预措施代码:

Intervention:

Single dose of placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

吉林 

市(区县):

长春 

Country:

China 

Province:

Jilin 

City:

Changchun 

单位(医院):

吉林大学第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital, Jilin University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

PK参数

指标类型:

主要指标 

Outcome:

PK parameters

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗-阿巴西普抗体及抗CTLA-4-T抗体

指标类型:

次要指标 

Outcome:

Anti-abatacept antibodies and anti-CTLA-4-T antibodies

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

次要指标 

Outcome:

AE

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 years
最大 Max age 45 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):

区组随机

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

blocked randomization

盲法:

Blinding:

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):

不公开

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

No Participant Data sharing plan

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:

通过纸质CRF记录

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

record in paper CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-06-20
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