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A single center clinical study of evaluating the injection of microRNA2911 plasmid in healthy adults

注册号：

Registration number：

ITMCTR2000003169

最近更新日期：

Date of Last Refreshed on：

2020-03-31

注册时间：

Date of Registration：

2020-03-31

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

一项评价microRNA2911注射质粒在健康成人中的单中心的临床研究

Public title：

A single center clinical study of evaluating the injection of microRNA2911 plasmid in healthy adults

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价microRNA2911注射质粒在健康成人中安全性和耐受性的临床研究

Scientific title：

A clinical study evaluating the safety and tolerability of microRNA2911 plasmids in healthy adults

研究课题的正式科学名称简写：

Scientific title acronym：

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：

ChiCTR2000031432 ; ChiMCTR2000003169

申请注册联系人：

王延博

研究负责人：

张辰宇

Applicant：

Yanbo Wang

Study leader：

Chenyu Zhang

申请注册联系人电话：

Applicant telephone：

+86 15751865780

研究负责人电话：

Study leader's telephone：

+86 13913994223

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：

ybwang91@126.com

研究负责人电子邮件：

Study leader's E-mail：

cyzhang@nju.edu.cn

申请单位网址(自愿提供)：

Study leader's 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：

江苏省南京市栖霞区仙林大道163号

研究负责人通讯地址：

江苏省南京市栖霞区仙林大道163号

Applicant address：

163 Xianling Avenue, Qixia District, Nanjing, Jiangsu, China

Study leader's address：

163 Xianling Avenue, Qixia District, Nanjing, Jiangsu, 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：

南京大学

Applicant's institution：

Nanjing University

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

2013/8/26 0:00:00

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：

南京大学

Primary sponsor：

Nanjing University

研究实施负责（组长）单位地址：

江苏省南京市栖霞区仙林大道163号

Primary sponsor's address：

163 Xianling Avenue, Qixia District, Nanjing, Jiangsu, 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)：

江苏

市(区县)：

南京

Country：

China

Province：

Jiangsu

City：

Nanjing

单位(医院)：

南京鼓楼医院

具体地址：

江苏省南京市鼓楼区中山路321号

Institution
hospital：

Nanjing Drum Tower hospital

Address：

321 Zhongshan Avenue, Nanjing, Jiangsu Province

经费或物资来源：

中央高校基本科研业务费

Source(s) of funding：

Basic scientific research operating expenses of central universities

研究疾病：

新型冠状病毒肺炎(COVID-19)

研究疾病代码：

Target disease：

Novel Coronavirus Pneumonia (COVID-19)

Target disease code：

研究类型：

Study type：

基础科学研究

Basic Science

研究设计：

Study design：

不同剂量对照

Dose comparison

研究所处阶段：

Study phase：

I期临床试验

Phase I clinical trial

研究目的：

评价microRNA2911注射质粒在健康人中的安全性和耐受性

Objectives of Study：

To evaluate the safety and tolerance of microRNA2911 plasmid in healthy people.

药物成份或治疗方案详述：

采用开放、剂量递增试验设计，入组为健康人（本项目研究人员志愿参与），计划入组15例受试者。受试者经筛选后依次入组至第1-5剂量组，静脉滴注给予microRNA2911质粒，每例受试者可累计接受3次静脉滴注给药，滴注时长10分钟。剂量递增采取加速滴定结合“3+3”试验设计。每例受试者只能接受一个剂量的试验，不得对同一受试者进行剂量递增。第1、2组受试者隔天一次（QOD），第3、4、5组每天给药一次（QD），完成2次给药后，通过对受试者进行临床观察、生命体征、体格检查、实验室检查，心电图检查等，评估不良事件（Adverse Event, AE）及不良反应（Adverse Reaction，ADR）。经研究者评估安全性和耐受性良好，没有剂量限制性毒性（DLT）发生，可以开始下一剂量组试验，同时该组第3次给药按计划正常进行，完成3次给药后持续观察28天。同时，采集不同时间点血样。

Description for medicine or protocol of treatment in detail：

An open, dose-increasing trial design will be adopted to enroll healthy people (the researchers of this project volunteered to participate), and 15 subjects will be planned to be enrolled. Subjects were selected and enrolled into the 1-5 dose group. MicroRNA2911 plasmid was given by intravenous infusion. Each subject could receive 3 times of intravenous infusion for 10 minutes. The experimental design of accelerating titration combined with "3+3" was adopted for dose increasing. Each subject may only receive one dose of the test and may not increase the dose for the same subject. Subjects in groups 1 and 2 were given drugs every other day (QOD), while those in groups 3, 4 and 5 were given drugs once a day (QD). After giving drugs for two times, the subjects were evaluated for Adverse Event (AE) and Adverse Reaction (ADR) by clinical observation, vital signs, physical examination, laboratory examination and electrocardiogram examination. After the investigator's assessment of safety and tolerability, no dose limiting toxicity (DLT) occurred, the next dose group trial could be started, and the third dose of the group was administered as planned, followed by continuous observation for 28 days after the completion of the third dose. Meanwhile, blood samples were collected at different time points.

纳入标准：

1. 签署知情同意书当日年龄 18 周岁以上（含 18 周岁）的健康男性或女性受试者； 2. 男性体重 ≥ 50kg，女性体重≥ 45kg，体重指数（BMI）在 19～28 kg/m2（含 19 和 28）范围内（BMI=体重（kg）/身高 2（m2））； 3. 筛选期体格检查、生命体征、血常规、尿常规、血生化、凝血三项、腹部 B 超、胸部 X 片等检查结果必须在与年龄和性别相符合的正常范围内，或 者 符 合 方 案 规 定 ， 或 者 如 果 超 出 正 常 范 围 被 判 定 为 “ 无 临 床 意 义 （NCS）”； 4. 12 导联心电图正常，男性 QTcF＜430ms，女性 QTcF＜450ms；QTc 间期 以 Fridericia 公式校正（QTcF = QT/(RR^0.33)，RR 为标准化的心率值，根 据 60 除以心率而得）； 5. 育龄妇女妊娠试验阴性； 6. 同意自筛选至末次研究药物给药后至少 3 个月内禁欲或采取有效的非药物 避孕措施者（对于女性受试者还要求在进入研究前两周开始禁欲或采取有 效的非药物避孕措施者）； 7. 受试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，理解并签署知情同意书。

Inclusion criteria

1. Healthy male or female subjects >=18 years old at the date of signing the informed consent; 2. Male body weight 50kg, female body weight >=45kg, body mass index (BMI) in the range of 19-28kg / m2 (including 19 and 28) (BMI = weight (kg) / height 2 (M2)); 3. The results of physical examination, vital signs, blood routine, urine routine, blood biochemistry, blood coagulation, abdominal B-ultrasound, chest X-ray and other examinations in the screening period must be within the normal range consistent with age and gender, or meet the requirements of the program, or be judged as "NCS" if they are beyond the normal range; 4. 12 lead ECG was normal, QTCF was less than 430ms in men and 450 ms in women; QTc interval was corrected by friderica formula (QTCF = QT / (RR ^ 0.33), RR was the standardized heart rate value, which was obtained by dividing 60 by heart rate); 5. Pregnancy test is negative in women of childbearing age; 6. Agree to abstain or take effective non drug contraceptive measures within at least 3 months from screening to the last study drug administration (female subjects also require to start abstinence or take effective non drug contraceptive measures two weeks before entering the study); 7. Subjects who can communicate well with researchers, understand and comply with the requirements of this study, and understand and sign the informed consent.

排除标准：

1. 过敏体质或已知对研究药物/同类药物过敏的患者； 2. 经常使用镇静、安眠药或其他成瘾性药物的患者；在首次给药前 12 个月内有药 物滥用史或药物滥用筛查阳性的患者； 3. 酗酒者或筛选前 6 个月内经常饮酒，平均每周饮酒超过 14 单位酒精的患者 （1 单位= 360mL 啤酒或 45mL 酒精量为 40%的烈酒或 150mL 葡萄酒），嗜烟或戒烟时间少于 3 个月的患者，酒精呼气测试及烟碱测试阳性的患者，并且在试验期 间不能禁烟和禁酒； 4. 首次给药前一个月内使用了任何处方药、中草药类补药的患者；首次给药前 2 周内 使用了任何非处方药（OTC）、食物补充剂（包括维生素、钙片等）的患者；首次给药前两周内使用过避孕药的患者； 5. 首次给药前 3 个月内参加过其它临床试验并服用研究药物的患者； 6. 首次给药前 3 个月内参加献血（含成分献血）或失血400 mL的患 者，筛选前 1个月内参加献血（含成分献血）或失血200 mL，或接受输血的患者； 7. 首次给药前 3 年内有自主神经功能失调史和/或现病史（如，反复发作的晕厥、心悸等）； 8. 既往有心血管、肝脏、肾脏、肺部、消化道、神经系统疾病等病史，有可能有显著影响药物吸收、分布、代谢和排泄的任何病史或病情的患者。具有可能对参加试验的受试者构成危害的任何病史或病情。研究者应考虑以下病史或病情：炎 症性胃肠炎、胃食管反流、胃肠道或直肠出血史；胰腺损伤或胰腺炎病史；较 大的手术史比如胃切除术、胃肠吻合术、或肠切除术等；急慢性肾功能不全病 史，肾移植病史； 9. 筛选前一周内有严重的呕吐、腹泻病史的患者； 10. 妊娠期、哺乳期女性受试者和不能按要求进行避孕的育龄女性受试者； 11. 乙肝表面抗原阳性，丙肝抗体阳性，梅毒抗体阳性，HIV 抗体阳性的患者； 12. 对饮食有特殊要求，不能遵守所提供的饮食和相应的规定的患者； 13. 在首次给药前 48 小时直至研究结束，拒绝停用任何包含甲基黄嘌 呤的饮料或食物，例如咖啡、茶、可乐、巧克力等的受试者； 14. 在首次给药前 7 天直至研究结束，拒绝停用任何包含葡萄柚的饮料或食物的受试者； 15. 静脉采血困难或不能耐受静脉穿刺的受试者； 16. 经研究者判断，具有其他不适合参加本研究的因素（包括且不限于不能理 解研究要求、依从性差、体弱等）的受试者。

Exclusion criteria：

1. Patients with allergic constitution or known allergy to study drug / similar drug; 2. Patients who often use sedatives, sleeping pills or other addictive drugs; patients who have a history of drug abuse or positive drug abuse screening within 12 months before the first administration; 3. Alcoholics or patients who drink more than 14 units of alcohol per week (1 unit = 360ml of beer or 45ml of spirits or 150ml of wine with 40% of alcohol), patients who are addicted to smoking or quit smoking for less than 3 months, patients who are positive in alcohol breath test and nicotine test, and can not be banned from smoking or alcohol during the test period; 4. Patients who used any prescription medicine or Chinese herbal medicine supplement within one month before the first administration; patients who used any over-the-counter medicine (OTC), food supplement (including vitamins, calcium tablets, etc.) within two weeks before the first administration; patients who used contraceptive within two weeks before the first administration; 5. Patients who participated in other clinical trials and took the study drug within 3 months before the first administration; 6. The patients who participated in blood donation (including component blood donation) or lost 400ml blood within 3 months before the first administration, and the patients who participated in blood donation (including component blood donation) or lost 200ml blood within 1 month before screening, or received blood transfusion; 7. There was a history of autonomic nervous dysfunction and / or current history (such as recurrent syncope, palpitation, etc.) within 3 years before the first administration; 8. Patients with previous history of cardiovascular, liver, kidney, lung, digestive tract, nervous system diseases, and any history or condition that may significantly affect drug absorption, distribution, metabolism and excretion. Any medical history or condition that may be hazardous to the subjects participating in the trial. Researchers should consider the following medical history or conditions: inflammatory gastroenteritis, gastroesophageal reflux, gastrointestinal or rectal bleeding; history of pancreatic injury or pancreatitis; major surgical history such as gastrectomy, gastroenterostomy, or enterotomy; history of acute and chronic renal insufficiency, history of kidney transplantation; 9. Screening the patients with severe vomiting and diarrhea in the previous week; 10. Pregnant and lactating female subjects and those of childbearing age who could not use contraception as required; 11. Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive; 12. Patients who have special requirements for diet and fail to comply with the provided diet and corresponding regulations; 13. Subjects who refused to stop using any drink or food containing methylxanthine, such as coffee, tea, cola, chocolate, etc., 48 hours before the first administration until the end of the study; 14. Subjects who refused to discontinue any drink or food containing grapefruit 7 days before the first administration until the end of the study; 15. Subjects with difficulty in venous blood collection or intolerability to venipuncture; 16. Subjects with other unsuitable factors (including but not limited to the inability to understand the research requirements, poor compliance, weakness, etc.) judged by the researcher.

研究实施时间：

Study execute time：

从From 2020-04-01

至To      2020-08-31

征募观察对象时间：

Recruiting time：

从From 2020-05-01

至To      2020-05-31

干预措施：

Interventions：

组别：

不同剂量组

样本量：

15

Group：

Different dose groups

Sample size：

干预措施：

注射剂量

干预措施代码：

Intervention：

Injection dose

Intervention code：

样本总量 Total sample size ： 15

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

南京鼓楼医院

单位级别：

三甲医院

Institution/hospital：

Nanjing Drum Tower Hospital

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

安全性和耐受性

指标类型：

主要指标

Outcome：

Safety and tolerance

Type：

Primary indicator

测量时间点：

测量方法：

不良事件以及严重不良事件的发生率、实验室检查、生命体征、体格检查和12导联心电图（ECG）的记录结果

Measure time point of outcome：

Measure method：

指标中文名：

药代动力学

指标类型：

次要指标

Outcome：

Pharmacokinetics

Type：

Secondary indicator

测量时间点：

测量方法：

药代动力学参数：AUCinf ，AUC0-t ，AUC0-tau，Cmax，Tmax，t1/2，CL，Vz，MRTinf，Rac(AUC)，Rac(Cmax)

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：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 70 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由第三方非参试人员使用计算机随机生成

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

Randomly generated by a third party non-participant using a computer

盲法：

随机双盲试验

Blinding：

Randomized double-blind trial

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）：

http://www.medresman.org.cn/register.aspx

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

http://www.medresman.org.cn/register.aspx

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：

1.采用病例记录表。为了保证数据的完整性、准确性和可靠性，本次研究中采取了以下措施： （1）选择有资格和经验的研究人员； （2）在研究开始前通过讲座和文字材料等向研究人员详细介绍本试验方案的内容，并共同对可能发生的问题制定解决方案； （3）统计阶段对数据进行盲态核查。如存在偏差，由研究人员进行确认或修正。 2. 使用电子采集和管理系统ResMan进行数据的采集和管理。

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

1. Case Record Form. In order to ensure the integrity, accuracy and reliability of the data, the following measures were taken in this study: (1)Qualified and experienced researchers; (2) We will introduce the contents of the experimental program to the researchers in detail through lectures and written materials before the study starts,and work together to develop solutions to possible problems; (3) We will conduct blind verification of data in the statistical stage.If there is a deviation, the researcher shall confirm or correct it. 2. Data collection and management by electronic acquisition and management system ResMan.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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