中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2100051434
最近更新日期： Date of Last Refreshed on：	2022-06-12 00:47:09
注册时间： Date of Registration：	2021-09-23 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	评价千层纸素片在健康成年受试者单次及多次口服给药后的安全性、耐受性、药代动力学和食物影响的Ⅰ期临床试验
Public title：	A phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and food effects of Melaleuca tablet in healthy adult subjects after single and multiple oral administration
注册题目简写：
English Acronym：
研究课题的正式科学名称：	评价千层纸素片在健康成年受试者单次及多次口服给药后的安全性、耐受性、药代动力学和食物影响的Ⅰ期临床试验
Scientific title：	A phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and food effects of Melaleuca tablet in healthy adult subjects after single and multiple oral administration
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：	葛展虹	研究负责人：	张建良
Applicant：	Ge Zhanhong	Study leader：	Zhang Jianliang
申请注册联系人电话： Applicant telephone：	+86 15157694842	研究负责人电话： Study leader's telephone：	+86 18930812345
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：	QLchictr@163.com	研究负责人电子邮件： Study leader's E-mail：	zhangjianliang@shphc.org.cn
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：	南京江北新区新锦湖路3-1号	研究负责人通讯地址：	上海市金山区漕廊公路2901号
Applicant address：	3-1 Xinjinhu Road, Jiangbei New District, Nanjing, Jiangsu	Study leader's address：	2901 Caolang Road, Jinshan District, Shanghai
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：	南京芩领医药科技有限公司
Applicant's institution：	Nanjing Qinling Pharmaceutical Technology Company Limited
研究负责人所在单位：	上海市公共卫生临床中心
Affiliation of the Leader：	Shanghai Public Health Clinical Center

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-E045-02	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：	上海市公共卫生临床中心医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Shanghai Public Health Clinical Center
伦理委员会批准日期： Date of approved by ethic committee：	2021-08-06 00:00:00
伦理委员会联系人：	刘峰
Contact Name of the ethic committee：	Liu Feng
伦理委员会联系地址：	上海市金山区漕廊公路2901号
Contact Address of the ethic committee：	2901 Caolang Road, Jinshan District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 37990333 8349	伦理委员会联系人邮箱： Contact email of the ethic committee：	lunliweiyuanhui2009@126.com

研究实施负责（组长）单位：

上海市公共卫生临床中心

Primary sponsor：

Shanghai Public Health Clinical Center

研究实施负责（组长）单位地址：

上海市金山区漕廊公路2901号

Primary sponsor's address：

2901 Caolang Road, Jinshan District, Shanghai

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)：	南京芩领医药科技有限公司	具体地址：	江北新区新锦湖路3-1号
Institution hospital：	Nanjing Qinling Pharmaceutical Technology Company Limited	Address：	3-1 Xinjinhu Road, Jiangbei New District

经费或物资来源：

自筹

Source(s) of funding：

Self-raised

研究疾病：

肝癌

Target disease：

hepatic carcinoma

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：评价千层纸素片单次口服给药后的安全性和耐受性；次要目的：评价千层纸素片单次口服给药后的药代动力学特征。

Objectives of Study：

Main purpose: To evaluate the safety and tolerability of Melaleuca vulgaris tablets after a single oral administration; Secondary objective: To evaluate the pharmacokinetic characteristics of Melaleuca paper tablets after a single oral administration.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Fully understand the purpose, nature, method and possible adverse reactions of this trial, volunteer as a subject, and sign the informed consent (ICF) before any research procedure begins, and guarantee that any procedure will involve myself in the research ;
2. Healthy adult male and female subjects over 18 years old (including 18 years old), with a sex (male:female) ratio of 1:1 (except for study 1 group 1);
3. Female weight >= 45.0kg, male weight >= 50.0kg, body mass index (BMI) within the range of 18.0-26.0 kg/m2 (including boundary values); body mass index (BMI) = weight (kg) / height 2 (m2) ;
4. Based on the detailed medical history, complete physical examination, vital signs examination, laboratory examination, electrocardiogram, chest radiograph, and abdominal B-ultrasound examination results showing no abnormality or abnormality without clinical significance; subjects who are judged by the investigator to be in good health ;
5. The subjects voluntarily take effective contraceptive measures from the screening period to 6 months after the end of the study, of which non-drug contraceptive measures should be used voluntarily during the trial period; and the subjects have no pregnancy from the screening period to 6 months after the end of the study , sperm donation, egg donation plan;
6. The subjects can communicate well with the researcher, voluntarily and can comply with the restrictions and procedures of the research, and accept hospitalization for observation.

排除标准：

1. 有临床显著的心血管、肝脏、肾脏、呼吸、血液和淋巴、内分泌、免疫、精神、神经、胃肠道系统等慢性疾病史或严重疾病史；
2. 有特定过敏史者，或过敏体质（如对两种或以上药物、食物如牛奶和花粉过敏者），或已知对本药组分或类似物过敏者；
3.有吞咽困难或任何影响药物吸收的胃肠道疾病史；
4. 不能耐受静脉穿刺者，有晕针晕血史者；
5. 对饮食有特殊要求，不能遵守提供的饮食和相应的规定者；
6. 在整个试验期间及未来6个月内有妊娠计划，试验期间不愿采取一种或一种以上的非药物避孕措施（如完全禁欲、避孕环、伴侣结扎等）者，或在整个试验期间及研究结束后6个月内有捐精、捐卵计划者；
7. 筛选前6个月内有药物滥用史，或筛选前3个月内使用过毒品者；
8. 筛选前3个月内每日吸烟量大于5支，或试验期间不能停止使用任何烟草类产品者；
9. 筛选前3个月内经常饮酒（每周饮酒超过14个标准单位，1标准单位含14g酒精，如360mL啤酒或45mL酒精量为40%的烈酒或150mL葡萄酒）者，或既往酗酒（即男性每周饮酒超过28个标准单位，女性每周饮酒超过21个标准单位），或试验期间不能禁酒者；
10. 筛选前3个月内献血包括成分血或大量失血（≥200mL），接受输血或使用血制品者；
11. 筛选前3个月内接受过手术，或者计划在研究期间进行手术者，及凡接受过会影响药物吸收、分布、代谢、排泄的手术者；
12. 筛选前3个月内每天饮用过量茶、咖啡和/或富含咖啡因的饮料（8杯以上，1杯=250 mL）者、富含黄嘌呤的食物或饮料等影响药物吸收、分布、代谢、排泄的特殊饮食者；
13. 筛选前3个月内参加过其他药物临床试验者并使用了试验药物者；
14. 筛选前1个月内接受过疫苗接种或者计划在研究期间进行疫苗接种者；
15. 筛选前1个月内使用过任何影响肝药酶活性的药物，如氯丙嗪、保泰松等；
16. 筛选前14天内使用了任何处方药、非处方药、中草药和膳食补充剂/保健（包括维生素等）者；
17. 筛选前7天内过量食用火龙果、芒果、柚子、酸橙、杨桃或由其制备的食物或饮料者；
18. 生命体征检查异常有临床意义者，参考正常值范围（包括临界值）：坐位收缩压90~139mmHg，舒张压60~89mmHg，坐位脉搏60~100次/分，体温（耳温）35.4~37.7℃，呼吸16~20次/分，具体情况由研究者综合判定；
19. 实验室检查及辅助检查任何项目异常并经研究者判断有临床意义者；
20. 乙肝病毒学指标、丙型肝炎病毒抗体、抗人类免疫缺陷病毒抗体或抗梅毒螺旋体特异性抗体检查有一项或一项以上异常有临床意义者；
21. 筛选期妊娠检查阳性的妇女；
22. 酒精呼气检测结果阳性；
23. 药筛（吗啡、冰毒、氯胺酮、摇头丸、大麻）检测阳性者；
24. 自筛选至-1天内饮用过量茶、食用过富含巧克力、任何富含咖啡因（8杯以上，1杯=250mL）、富含黄嘌呤的食物或饮料等影响药物吸收、分布、代谢、排泄的特殊饮食者；
25. 自筛选至-1天内过量食用火龙果、芒果、柚子、酸橙、杨桃或由其制备的食物或饮料者；
26. 自筛选至-1天内发生急性疾病者；
27. 自筛选至-1天内使用了任何处方药、非处方药、中草药和膳食补充剂/保健品（包括维生素等）者；
28. 自筛选至-1天内过量使用烟草类产品或酒精类产品者；
29. 研究者认为受试者有任何不适宜参加本试验的情况。

Exclusion criteria：

1. Have a history of clinically significant chronic diseases or serious diseases of the cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, mental, neurological, gastrointestinal systems, etc.;
2. Those with a history of specific allergies, or allergies (such as those who are allergic to two or more drugs, foods such as milk and pollen), or those who are known to be allergic to the components or analogs of this drug;
3. A history of dysphagia or any gastrointestinal disease that affects drug absorption;
4. Those who cannot tolerate venipuncture, and those who have a history of fainting and bleeding;
5. Those who have special requirements for diet and cannot comply with the provided diet and corresponding regulations;
6. Those who have a pregnancy plan during the entire trial period and the next 6 months, are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, contraceptive ring, partner ligation, etc.) Those who have sperm or egg donation plans during and within 6 months after the end of the study;
7. Those who have a history of drug abuse within 6 months before screening, or who have used drugs within 3 months before screening;
8. Those who smoked more than 5 cigarettes per day within 3 months before screening, or who could not stop using any tobacco products during the trial;
9. Those who regularly drink alcohol (more than 14 standard units per week, 1 standard unit contains 14g alcohol, such as 360mL beer or 45mL spirits with an alcohol content of 40% or 150mL wine) within 3 months before screening, or have been drinking heavily ( That is, men who drink more than 28 standard units per week and women who drink more than 21 standard units per week), or those who cannot abstain from alcohol during the trial;
10. Those who donated blood, including blood components or massive blood loss (>=200mL), received blood transfusion or used blood products within 3 months before screening;
11. Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion;
12. Those who drink too much tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL), food or beverages rich in xanthine, etc., within 3 months before screening, affect drug absorption and distribution , metabolism and excretion of special dieters;
13. Those who have participated in clinical trials of other drugs and used experimental drugs within 3 months before screening;
14. Those who have been vaccinated within 1 month before screening or plan to be vaccinated during the study;
15. Have used any drugs that affect the activity of liver drug enzymes, such as chlorpromazine, phenylbutazone, etc., within 1 month before screening;
16. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and dietary supplements/health care (including vitamins, etc.) within 14 days before screening;
17. Excessive consumption of dragon fruit, mango, grapefruit, lime, star fruit or food or drink prepared therefrom within 7 days before screening;
18. For patients with clinically significant abnormal vital signs, refer to the normal range (including the critical value): systolic blood pressure 90~139mmHg in sitting position, diastolic blood pressure 60~89mmHg, pulse rate in sitting position 60~100 beats/min, body temperature (ear temperature) 35.4~ 37.7°C, breathing 16-20 times/min, the specific situation will be determined comprehensively by the investigator;
19. Any abnormalities in laboratory examinations and auxiliary examinations that are judged by the investigator to be clinically significant;
20. One or more abnormalities in the examination of hepatitis B virological indicators, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody are clinically significant;
21. Women with positive pregnancy test during the screening period;
22. Positive result of alcohol breath test;
23. Those who have tested positive for drug screening (morphine, methamphetamine, ketamine, ecstasy, marijuana);
24. Excessive consumption of tea, chocolate-rich food, any food or drink rich in caffeine (more than 8 cups, 1 cup = 250mL), and xanthine-rich foods or drinks within -1 days from screening to affect drug absorption, distribution, and metabolism , Excretion of special dieters;
25. Excessive consumption of dragon fruit, mango, grapefruit, lime, star fruit or food or drink prepared therefrom within -1 day from screening;
26. Those with acute disease within -1 days from screening;
27. Those who have used any prescription drugs, non-prescription drugs, Chinese herbal medicines and dietary supplements/health products (including vitamins, etc.) within -1 days from screening;
28. Excessive use of tobacco products or alcohol products within -1 days from screening;
29. The investigator believes that the subject has any circumstances that are not suitable for participating in this trial.

研究实施时间：

Study execute time：

从 From 2021-08-27 00:00:00至 To 2022-01-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2021-09-17 00:00:00 至 To 2021-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	28
Group：	Experimental group	Sample size：	28
干预措施：	千层纸素片	干预措施代码：
Intervention：	Melaleuca Paper Sheet	Intervention code：

组别：	对照组	样本量：	25
Group：	Control Group	Sample size：	25
干预措施：	安慰剂	干预措施代码：
Intervention：	placebo	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市公共卫生临床中心	单位级别：	三级甲等
Institution hospital：	Shanghai Public Health Clinical Center	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	安全性指标	指标类型：	主要指标
Outcome：	safety indication	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	药代动力学指标	指标类型：	主要指标
Outcome：	Pharmacokinetic Indicators	Type：	Primary 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：

标本中文名：	粪便	组织：
Sample Name：	feces	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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age		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）：

在研究中每名受试者接受研究的顺序将由随机方案确定。随机方案由统计单位应用 SAS（9.4 或更高版本）按随机化程序产生。

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

In the study, the order in which each subject will receive the study will be determined by the randomization scheme. The random plan is generated by the statistical company using SAS (version 9.4 or higher) according to the randomization procedure.

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：	Not stated
Blinding：	Not stated
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	数据库由上海凌先医药科技有限公司数据管理部门建立，按照FDA 21 CFR Part 11 在经验证的系统中遵循CDISC和ICH GCP标准。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The database was established by Data management department of Shanghai Lingxian MED and complies with CDISC and ICH GCP standards in a verified system in accordance with FDA 21 CFR Part 11.
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：	本研究数据管理由上海凌先医药科技有限公司负责，以确保临床试验数据的有效性、完整性、私密性和可溯源性。由研究者或经研究者授权的人员将信息录入eCRF中，任何对数据做出的改动都会被自动记录在系统中。 eCRF填写完成后应及时通过网络提交，eCRF系统中数据经 SDV、DM审核、医学核查及统计核查，质疑处理确认无疑问后，在数据锁定前须有研究者或授权人进行电子签名，声明eCRF 系统中的所有信息均属实。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The data management of this study is managed by Shanghai Lingxian MED to ensure the validity, completeness, privacy and traceability of clinical trial data. The researcher or a person authorized by the researcher records the information into eCRF, and any changes made to the data will be automatically recorded in the system. After completing eCRF, it should be submitted online in time. The data in eCRF system has been reviewed by SDV, DM, medical and statistical verification. After the questioning process is confirmed, there must be an electronic signature by the researcher or authorized person to declare that all information in eCRF is true before the data is locked.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2021-09-23 20:01:38