Today is 2022-01-28

Pharmacokinetics, Safety and Immunogenicity of subcutaneous and intravenous QX005N in Healthy Subjects:A Randomized, open-label, Parallel-group,Single-dose, Single-center, Phase Ⅰ Study
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注册号:

Registration number:

ChiCTR2200055637 

最近更新日期:

Date of Last Refreshed on:

2022-01-15 

注册时间:

Date of Registration:

2022-01-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项在健康受试者中评估皮下注射和静脉滴注QX005N注射液药代动力学特征、安全性和免疫原性的随机、开放、平行、单次给药、单中心、Ⅰ期临床研究 

Public title:

Pharmacokinetics, Safety and Immunogenicity of subcutaneous and intravenous QX005N in Healthy Subjects:A Randomized, open-label, Parallel-group,Single-dose, Single-center, Phase Ⅰ Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项在健康受试者中评估皮下注射和静脉滴注QX005N注射液药代动力学特征、安全性和免疫原性的随机、开放、平行、单次给药、单中心、Ⅰ期临床研究 

Scientific title:

Pharmacokinetics, Safety and Immunogenicity of subcutaneous and intravenous QX005N in Healthy Subjects:A Randomized, open-label, Parallel-group,Single-dose, Single-center, Phase Ⅰ Study 

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:

李秀秀 

研究负责人:

陈桂玲 

Applicant:

Xiuxiu Li 

Study leader:

Guiling Chen 

申请注册联系人电话:

Applicant telephone:

18800172336 

研究负责人电话:

Study leader's telephone:

18343113983 

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:

lixiuxiu@qyuns.net 

研究负责人电子邮件:

Study leader's E-mail:

chenguiling707@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:

泰州市药城大道907号1号楼1310室 

研究负责人通讯地址:

浙江省杭州市下城区东新路848号 

Applicant address:

Room 1310, Building 1, No.907 Yaocheng Avenue, Taizhou, Jiangsu, China 

Study leader's address:

No. 848, Dongxin Road, Xiacheng District, Hangzhou City, Zhejiang Province 

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:

江苏荃信生物医药股份有限公司 

Applicant's institution:

Jiangsu Qyuns Therapeutics 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:

2021伦审第(34)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:

树兰(杭州)医院临床试验伦理委员会 

Name of the ethic committee:

Clinical Trial Ethics committee of SHULAN(HANGZHOU)HOSPITAL 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

管文花 

Contact Name of the ethic committee:

Wenhua Guan 

伦理委员会联系地址:

浙江省杭州市下城区东新路848号 

Contact Address of the ethic committee:

No. 848, Dongxin Road, Xiacheng District, Hangzhou City, Zhejiang Province 

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:

树兰(杭州)医院 

Primary sponsor:

SHULAN(HANGZHOU)HOSPITAL 

研究实施负责(组长)单位地址:

浙江省杭州市下城区东新路848号 

Primary sponsor's address:

No. 848, Dongxin Road, Xiacheng District, Hangzhou City, Zhejiang Province 

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

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏荃信生物医药有限公司

具体地址:

泰州市药城大道907号1号楼1310室

Institution
hospital:

Jiangsu Qyuns Therapeutics Co.,Ltd.

Address:

Room 1310, Building 1, No.907 Yaocheng Avenue, Taizhou, Jiangsu, China

经费或物资来源:

自费 

Source(s) of funding:

At sponsor's own expense 

研究疾病:

特应性皮炎 

Target disease:

Atopic dermatitis 

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:

主要目的: 评价单次皮下注射和静脉滴注QX005N在健康受试者中的药代动力学特征,考察皮下注射QX005N与静脉滴注QX005N相比下的绝对生物利用度。 次要目的: 评价单次皮下注射和静脉滴注QX005N在健康受试者中的安全性; 评价单次皮下注射和静脉滴注QX005N在健康受试者中的免疫原性。 

Objectives of Study:

Primary objective To evaluate the pharmacokinetics (PK) of subcutaneous and intravenous QX005N in healthy subjects, to investigate the absolute bioavailability of subcutaneous QX005N compared with intravenous QX005N. Secondary objective To evaluate the safety of subcutaneous and intravenous QX005N in healthy subjects; To evaluate the immunogenicity of subcutaneous and intravenous QX005N in 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:

满足全部入选标准方可入选: 1.签署知情同意书时,年龄在18~50(含两端值)岁的健康成年人; 2.男性受试者体重≥50.0 kg,女性受试者体重≥45.0 kg,并且均≤100.0 kg;体重指数(BMI=体重/身高平方(kg/m2))在18.0~28.0 kg/m2范围内(包括两端值); 3.经全面检查包括生命体征、体格检查、实验室检查、12导联心电图、腹部彩超及胸正位片检查正常或异常但无临床意义; 4.同意在试验期间以及试验结束后6个月内无生育计划且自愿采取有效避孕措施; 5.受试者充分了解试验目的、性质、方法以及可能发生的不良反应,自愿作为受试者,并签署知情同意书; 能够按照方案要求完成试验者。 

Inclusion criteria

Subjects who meet all the following inclusion criteria can be included: 1.Healthy adults who are 18 to 50 (including 18 and 50) years old when signing the ICFs; 2.Male subjects weight ≥50.0 kg and ≤100.0 kg, and female subjects weight ≥45.0 kg and ≤100.0 kg; the body mass index (BMI = weight/height square (kg/m2)) of subjects within the range of 18.0-28.0 kg/m2 (including 18.0 and 28.0); 3.Comprehensive examinations including vital signs、 physical examination and laboratory tests、12-lead ECG、abdominal color Doppler ultrasound and chest anteroposterior X-ray are normal or abnormal but not clinically significant; 4.Subjects agree to have no birth plan and take effective contraceptive measures voluntarily during the study period and within 6 months after the end of the study; 5.Subjects fully understand the study objective, nature, methods and possible adverse reactions, voluntarily become subjects, and sign the ICFs; Subjects can complete the trial as required in the protocol. 

排除标准:

满足下列1项排除标准即排除: 1.既往接受过同靶点(IL-4Rα)药物者; 2.两种及以上药物或食物过敏者,或经研究者判断可能会对研究药物或研究药物中的任何成分过敏者; 3.筛选前五年内曾有药物滥用史或试验前3个月使用过毒品者;或尿液药物滥用筛查阳性者; 4.乙肝表面抗原定性[HBsAg]、丙型肝炎病毒抗体[Anti-HCV]、丙型肝炎病毒核心抗原[HCV-cAg]、人免疫缺陷病毒[HIV]抗原抗体联合检测、梅毒螺旋体特异性抗体测定[TP-ELISA]有一项及以上阳性者; 5.筛选前7天内有感染(包括慢性或局部感染)者,有反复感染史并有易发生感染的基础疾病者,播散性单纯疱疹感染或复发性(>1次)或播散性带状疱疹史者,机会性感染史者; 6.有活动性结核史者,或者筛选时有活动性或潜伏性结核感染者; 7.研究者认为具有临床意义或影响研究的疾病或异常,包括但不限于神经系统、心血管系统、肾脏、肝脏、胃肠道、呼吸系统、血液系统、代谢、眼科(结膜炎、角膜炎)、妇科(仅女性受试者)、骨骼系统疾病或传染疾病; 8.筛选前4周内献血≥400mL,或失血≥400mL,或在筛选前8周内接受过输血者; 9.筛选前4周内或者计划在试验过程中接种活(减毒)疫苗者; 10.筛选前4周内使用过任何处方药、中草药,或筛选前2周内使用过非处方或膳食补充品(包括维生素、钙补充剂等); 11.筛选前3个月内平均每日吸烟量大于5支或习惯性使用含尼古丁制品; 12.筛选前6个月内平均每周饮酒量大于14单位酒精(1单位酒精=360mL啤酒或45 mL酒精含量为40%的烈酒或150mL葡萄酒)或给药前2天服用过含酒精的制品者; 13.筛选前3个月内或5个半衰期(以时间较长者为准)参加过任何药物或医疗器械的临床试验者; 14.妊娠检测阳性或处于哺乳期的女性受试者; 15.研究者认为其他任何可能影响受试者提供知情同意或遵循试验方案的情况,或受试者参加试验可能影响试验结果或自身安全的情况。 

Exclusion criteria:

Subjects who meet one of the following exclusion criteria should be excluded: 1.Prior receipt of anti-IL-4R drugs; 2.Subjects with two or more drug or food allergies, or subjects may be allergic to the IP or any component of the IP formulation ; 3.Subjects who had a history of drug abuse within 5 years before screening or had used drugs within 3 months prior to the trial or had a positive test for drug abuse in the urine; 4.Subjects who had one or more positive results for hepatitis B surface antigen[HBsAg], hepatitis C virus antibody [Anti-HCV], hepatitis C virus core antigen [HCV-cAg], HIV antigen/ antibody or Treponema pallidum specific antibody[ TP-ELISA] ; 5.Subjects with infection within 7 days before screening (including chronic or local infection); history of recurrent infection and underlying diseases that is prone to infection; history of disseminated herpes simplex infection or recurrent (>1 time) or disseminated herpes zoster (HZ), and history of opportunistic infection; 6.Subjects with a history of active tuberculosis, or subjects with active or latent tuberculosis infection at screening; 7.Diseases or abnormalities deemed clinically significant or affecting the study by the investigator, including but not limited to nervous system, cardiovascular system, kidney, liver, gastrointestinal tract, respiratory system, blood system, metabolism, ophthalmology (conjunctivitis, keratitis), Gynecology (female subjects only), skeletal disease or infectious disease; 8.Subjects who donated blood ≥ 400 ml within 4 weeks before screening, or had blood loss at least 400 ml, or had received blood transfusion within 8 weeks before screening; 9.Subjects who plan to receive live (attenuated) vaccine within 4 weeks before screening or during the trial; 10.Subjects who have used any prescription drugs, Chinese herbal medicines within 4 weeks before screening, or over-the-counter or dietary supplements (including vitamins, calcium supplements, etc.) within 2 weeks before screening; 11.Subjects who smoked more than 5 cigarettes per day or habitually used nicotine-containing products within 3 months before screening; 12.Subjects who had consumed more than 14 units of alcohol per week within 6 months before screening (1 unit alcohol = 360 ml beer or 45 ml liquor with 40% alcohol or 150 ml wine) or had consumed alcoholic products within 2 days before administration; 13.Subjects who have participated in clinical study of any drug or medical device within 3 months or five half-lives(whichever is longer) before screening; 14.Female subjects who are positive in pregnancy test or are breastfeeding; 15.Any other circumstances as judged by the investigator that may affect the subjects in providing ICFs or following the study protocol, or taking participation in the trial that may affect the results or the subjects’ safety . 

研究实施时间:

Study execute time:

From2022-01-31To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2022-02-01To 2022-04-30 

干预措施:

Interventions:

组别:

QX005N SC组

样本量:

12

Group:

QX005N SC组

Sample size:

干预措施:

QX005N注射液

干预措施代码:

Intervention:

QX005N Injection

Intervention code:

组别:

QX005N IV组

样本量:

12

Group:

QX005N IV组

Sample size:

干预措施:

QX005N注射液

干预措施代码:

Intervention:

QX005N Injection

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):

树兰(杭州)医院 

单位级别:

三级甲等 

Institution
hospital:

QX005N Injection  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

PK

指标类型:

主要指标 

Outcome:

PK

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

指标类型:

次要指标 

Outcome:

safety

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫原性

指标类型:

次要指标 

Outcome:

immunogenicity

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:

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 50 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):

由专职的处于非盲态的研究人员登录中央随机化系统,申请随机号和配发试验用药品。

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

This trial is made by full-time non-blinded researchers log in to the central randomization system to apply for the random number and distribution of test drugs.

盲法:

开放

Blinding:

open-label

是否共享原始数据:

IPD sharing

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):

暂无

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

Not available yet.

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:

病例报告表和电子数据采集和管理系统

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

Case report form and electronic data acquisition and management system

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2022-01-15
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