Today is 2020-12-01

A single-site, single-arm,open Phase I Study to Evaluate the Safety,tolerability and pharmacokinetic of CD24Fc in healthy adults
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注册号:

Registration number:

ChiCTR2000038672 

最近更新日期:

Date of Last Refreshed on:

2020-09-27 

注册时间:

Date of Registration:

2020-09-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价CD24Fc注射液在健康成人受试者中的安全性、耐受性和药代动力学特征的单中心、单臂、开放的Ⅰ期临床试验 

Public title:

A single-site, single-arm,open Phase I Study to Evaluate the Safety,tolerability and pharmacokinetic of CD24Fc in healthy adults 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价CD24Fc注射液在健康成人受试者中的安全性、耐受性和药代动力学特征的单中心、单臂、开放的Ⅰ期临床试验 

Scientific title:

A single-site, single-arm,open Phase I Study to Evaluate the Safety,tolerability and pharmacokinetic of CD24Fc in healthy adults 

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:

尹龙萍 

研究负责人:

方显锋 

Applicant:

Longpin Yin 

Study leader:

xianfeng Fang 

申请注册联系人电话:

Applicant telephone:

18761305865 

研究负责人电话:

Study leader's telephone:

18601030116 

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:

lpyin@oncoimmune.com 

研究负责人电子邮件:

Study leader's E-mail:

xfang@oncoimmune.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://gz.oncoimmune-gz.com/ 

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:

广州国际生物岛标准产业单元三期一栋602 

研究负责人通讯地址:

广州国际生物岛标准产业单元三期一栋602 

Applicant address:

Standard industry unit room 602, building 1, phase 3, Guangzhou international bio-island,Guangzhou, Guangdong,China 

Study leader's address:

Standard industry unit room 602, building 1, phase 3, Guangzhou international bio-island,Guangzhou, Guangdong,China 

申请注册联系人邮政编码:

Applicant postcode:

510320 

研究负责人邮政编码:

Study leader's postcode:

510320 

申请人所在单位:

广州昂科免疫生物技术有限公司 

Applicant's institution:

OncoImmune-Guangzhou,Inc. 

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:

京地伦药字2020第31-02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:

首都医科大学附属北京地坛医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Ditan Hospital affiliated to Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-09-17 

伦理委员会联系人:

周运翱 

Contact Name of the ethic committee:

Zhou YunAo 

伦理委员会联系地址:

北京市朝阳区京顺东街8号 

Contact Address of the ethic committee:

8 East Jingshun Road, Chaoyang District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-84322140 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

bjdtyyll@163.com 

研究实施负责(组长)单位:

首都医科大学附属北京地坛医院 

Primary sponsor:

Beijing Ditan Hospital affiliated to Capital Medical University 

研究实施负责(组长)单位地址:

北京市朝阳区京顺东街8号 

Primary sponsor's address:

8 East Jingshun Road, Chaoyang District, Beijing, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州昂科免疫生物技术有限公司

具体地址:

广州国际生物岛标准产业单元三期一栋602

Institution
hospital:

oncoimmune-gz

Address:

Standard industry unit room 602, building 1, phase 3, Guangzhou international bio-island,Guangzhou, Guangdong,China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

新型冠状病毒肺炎 

Target disease:

COVID-19 

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CD24Fc在健康成人受试者中的安全性和耐受性。 

Objectives of Study:

Evaluate the Safety,tolerability of CD24Fc in healthy adults 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1) 签署知情同意书时年龄≥18周岁,男女均可。 2) 体重在50~90 kg之间,体重指数(BMI)在19~26kg/m2之间(包括边界值)。 3) 同意在研究的第29天结束前不参与其他研究。 

Inclusion criteria

1) Both male and female aged ≥18 years when signing the informed consent form. 2) Body weight is between 50 and 90 kg, and body mass index (BMI) is between 19 and 26kg/m2 (including boundary value). 3) Agree not to participate in other studies until the end of the 29th day of the study. 

排除标准:

1) 对研究药物或其成分过敏者,或有过敏体质:如对两种或以上药物、食物过敏者;或对同类药物有过敏史者; 2) 筛选期有临床表现异常、需排除的疾病,包括但不限于精神神经系统、心血管系统、血液和淋巴系统、免疫系统、肾脏、肝脏、胃肠道、呼吸系统、代谢及骨骼等系统疾病及恶性肿瘤既往病史者; 3) 体格检查、生命体征检查、实验室检查(血常规、尿常规、血生化等)结果异常且有临床意义,并对本试验评估有影响者;其中,空腹血糖、LDL-C、甘油三酯任一项≥1.5ULN者不可入组; 4) 有临床意义的心电图检查异常者,PR间期≥210ms,QRS≥120ms,QTcF≥450ms,或者既往有临床意义房室传导阻滞; 5) 试验前4周内已知有细菌、病毒、真菌、寄生虫感染或其他感染或需要抗感染治疗或住院的任何感染性疾病,经临床医生判定可能影响试验结果者; 6) 采血困难或不能耐受静脉穿刺者,有晕针晕血史者; 7) 试验前3个月内献血或失血≥200mL,或计划在研究期间或研究结束后3个月内献血或血液成分者; 8) 试验前3个月内日吸烟量大于5支者及整个试验期间不能禁烟者; 9) 签署知情同意书前3个月内每周饮酒量大于14单位(1单位酒精≈360mL啤酒或45mL酒精含量为40%的烈酒或150mL葡萄酒),或给药前一天酒精呼气试验为阳性者(呼气酒精含量>0.0mg/100mL),或试验期间不能禁酒者; 10) 既往长期饮用过量(一天8杯以上,1杯=200mL)茶、咖啡或含咖啡因的饮料者; 11) 试验前14天内使用过任何药物(包括处方药、非处方药、中草药等)或保健品; 12) 药物成瘾和药物滥用检测一项或多项呈阳性者,试验前1年内有药物滥用/依赖史或毒品史者; 13) 人类免疫缺陷病毒(HIV)抗体、乙型肝炎表面抗原、丙型肝炎病毒抗体、梅毒螺旋体抗体检测阳性者; 14) 妊娠期、哺乳期女性或计划在试验期间怀孕的女性,以及在整个试验期间至试验结束后3个月内不愿采取屏障避孕措施的男性或女性; 15) 试验期间计划参加剧烈运动,包括身体接触性运动或碰撞性运动者; 16)试验前6个月内接受过重大外科手术者,或计划在研究期间进行外科手术者; 17) 试验前3个月内参加了任何药物临床试验且服用过试验药物者; 18) 研究者、研究中心、申办者和合同研究组织的雇员或相关人员; 19) 研究者认为受试者存在其他不适合参加研究的情况。 

Exclusion criteria:

1) Allergic to the study drugs or their ingredients, or allergic constitution: if allergic to two or more drugs or food;Or have allergic history to similar drugs; (2) Screening for diseases with abnormal clinical manifestations that need to be excluded, including but not limited to the mental nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism, bone and other systemic diseases and previous history of malignant tumors; 3) Abnormal and clinically significant results of physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry, etc.) and have an impact on the evaluation of this test;Among them, fasting blood glucose, LDL-C, triglyceride of any item ≥1.5ULN cannot be enrolled; 4) Abnormal ecg examination with clinical significance, PR interval ≥210ms, QRS≥120ms, QTcF≥450ms, or previous clinical significance of ATRIoventricular block; 5) Having any known bacterial, viral, fungal, parasitic or other infection or any infectious disease requiring anti-infective treatment or hospitalization within 4 weeks before the test, which may affect the test results as determined by the clinician; 6) Patients who have difficulty in blood collection or cannot tolerate vein puncture and have a history of fainting needles and blood; 7) Blood donation or blood loss ≥200mL within 3 months before the test, or plan to donate blood or blood composition within 3 months after the study; 8) Those who smoked more than 5 cigarettes per day in the 3 months before the test and could not smoke during the whole test period; 9) drink more than 14 units of alcohol (1 unit ≈360mL beer or 45mL 40% spirits or 150mL wine) per week within 3 months prior to signing the informed consent, or breath test positive for alcohol (breath alcohol >0.0mg/100mL) the day before administration, or cannot abstain during the test; 10) Past long-term excessive consumption (more than 8 cups a day, 1 cup =200mL) of tea, coffee or caffeinated beverages; 11) Used any medicine (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or health care products within 14 days before the trial; 12) Having a history of drug abuse/dependence or drug abuse within 1 year prior to the test; 13) Positive detection of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis C virus antibody, treponema Pallidum antibody; 14) Women who are pregnant, breastfeeding or planning to become pregnant during the course of the study, and men or women who do not wish to use barrier contraception throughout the study period and for a period of three months after the end of the study; 15) Those who plan to participate in vigorous exercise during the test, including contact or collision exercise; 16) Those who have undergone major surgery within 6 months prior to the study, or plan to undergo surgery during the study period; 17) Those who have participated in any drug clinical trial and taken the experimental drug within 3 months before the trial; 18) Researchers, research centers, sponsors and employees of contract research organizations or related personnel; 19) The researcher believes that the subject has other conditions that are not suitable for the study. 

研究实施时间:

Study execute time:

From2020-11-05To 2021-08-05 

征募观察对象时间:

Recruiting time:

From2020-11-05To 2021-06-05 

干预措施:

Interventions:

组别:

第一组

样本量:

3

Group:

Group 1

Sample size:

干预措施:

CD24Fc 240mg

干预措施代码:

Intervention:

CD24Fc 240mg

Intervention code:

组别:

第二组

样本量:

3

Group:

Group 2

Sample size:

干预措施:

CD24Fc 360mg

干预措施代码:

Intervention:

CD24Fc 360mg

Intervention code:

组别:

第三组

样本量:

6

Group:

Group 3

Sample size:

干预措施:

CD24Fc 480mg

干预措施代码:

Intervention:

CD24Fc 480mg

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京地坛医院 

单位级别:

三级 

Institution
hospital:

Beijing Ditan Hospital affiliated to Capital Medical University  

Level of the institution:

Lecel 3 

测量指标:

Outcomes:

指标中文名:

不良事件

指标类型:

主要指标 

Outcome:

AE

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 Sign monitoring

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:

实验室检查

指标类型:

主要指标 

Outcome:

Laboratory Testing

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

主要指标 

Outcome:

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:

药代动力学参数

指标类型:

次要指标 

Outcome:

PK

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗药抗体

指标类型:

次要指标 

Outcome:

ADA

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:

全血

组织:

Sample Name:

CBC

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

血清

组织:

Sample Name:

Serum

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 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):

单臂试验

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

Single arm

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

2021.8 药物临床试验登记与信息公示平台 www.chinadrugtrials.org.cn

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

2021.8 china drug trials registration and information publicity platform www.chinadrugtrials.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:

eCRF

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

eCRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-09-27
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