ChiCTR2400083835 版本V1.0 版本创建时间2024/05/06 10:26:38 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400083835 

最近更新日期：

Date of Last Refreshed on：

 2024-05-06 10:26:31 

注册时间：

Date of Registration：

 2024-05-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

SYN045片在健康成人受试者中单次给药的安全性、耐受性、药代动力学和食物影响I期临床研究

Public title：

Phase I clinical study to investigate the safety, tolerability, pharmacokinetic of single doses of SYN045 tablets in healthy subjects and the effect of food on pharmacokinetics

注册题目简写：

English Acronym：

研究课题的正式科学名称：

SYN045片在健康成人受试者中单次给药的安全性、耐受性、药代动力学和食物影响I期临床研究

Scientific title：

Phase I clinical study to investigate the safety, tolerability, pharmacokinetic of single doses of SYN045 tablets in healthy subjects and the effect of food on pharmacokinetics

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：

张炜 

研究负责人：

胡伟 

Applicant：

Wei Zhang 

Study leader：

Wei Hu 

申请注册联系人电话：

Applicant telephone：

 +86 551 6599 7141

研究负责人电话：

Study leader's
telephone：

+86 138 5608 6475

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：

 zhangpharmacy@163.com

研究负责人电子邮件：

Study leader's E-mail：

 hwgcp@ayefy.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：

安徽省合肥市经开区芙蓉路678号

研究负责人通讯地址：

安徽省合肥市经济技术开发区芙蓉路678号

Applicant address：

678 Furong Road, ETDZ, Hefei, Anhui Province

Study leader's address：

No. 678, Furong Road, Economic and Technological Development Zone, Hefei City, Anhui 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：

安徽医科大学第二附属医院药物临床试验中心

Applicant's institution：

Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University

研究负责人所在单位：

安徽医科大学第二附属医院药物临床试验中心

Affiliation of the Leader：

Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University

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：

 YW2024-068

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：

安徽医科大学第二附属医院药物临床试验伦理委员会

Name of the ethic committee：

Ethics Committee of The Second Hospital of Anhui Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-04-24 00:00:00

伦理委员会联系人：

张静

Contact Name of the ethic committee：

Jing Zhang

伦理委员会联系地址：

安徽省合肥市经开区芙蓉路678号

Contact Address of the ethic committee：

678 Furong Road, ETDZ, Hefei, Anhui Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 551 6380 6061

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：

安徽医科大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Anhui Medical University

研究实施负责（组长）单位地址：

安徽省合肥市经开区芙蓉路678号

Primary sponsor's address：

678 Furong Road, ETDZ, Hefei, Anhui 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)：

河北省

市(区县)：

Country：

China

Province：

Hebei

City：

单位(医院)：

石家庄四药有限公司

具体地址：

石家庄高新技术产业开发区槐安东路518号

Institution
hospital：

Shijiazhuang No.4 Pharmaceutical Co.,Ltd

Address：

No. 518, Huaian East Road, High-tech Industrial Development, Shijiazhuang

经费或物资来源：

石家庄四药有限公司

Source(s) of funding：

Shijiazhuang No.4 Pharmaceutical Co.,Ltd

研究疾病：

无  

Target disease：

None

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SYN045片在健康受试者中单次口服给药和不同饮食条件下给药的安全性和耐受性。 次要目的：评价SYN045片在健康受试者中单次口服给药和不同饮食条件下给药后的药代动力学特征。 探索性目的：探索SYN045在血浆、尿液和粪便中的代谢物谱。  

Objectives of Study：

Primary objective: To evaluate the safety and tolerability of SYN045 tablets administered orally as a single dose and under different dietary conditions in healthy subjects. Secondary objective: To evaluate the pharmacokinetic profile of SYN045 tablets after single oral administration and administration under different dietary conditions in healthy subjects. Exploratory Objective: To explore the metabolite profile of SYN045 in plasma, urine, and feces.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1) 健康受试者，男性和女性（男女均有），年龄18~45周岁（含边界值）； 2) 男性受试者的体重≥50.0 kg，女性受试者的体重≥45.0 kg，体重指数（BMI）在19~26 kg/m2[BMI=体重（kg）/身高2（m2）]范围内（含边界值）； 3) 受试者（包括男性受试者及其女性伴侣）愿意自筛选前2周至最后一次给药后6个月内无生育计划且自愿采取有效的非药物的避孕措施（参见附录）且无捐精、捐卵计划； 4) 受试者筛选前签署书面的知情同意书，并对研究内容、过程及可能出现的不良反应充分了解，且能够按照方案要求完成研究。

Inclusion criteria

1) Healthy subjects, male and female (both male and female), aged 18~45 years old (including boundary value); 2) The weight of male subjects ≥ 50.0 kg, the weight of female subjects ≥ 45.0 kg, and the body mass index (BMI) was within the range of 19~26 kg/m2 [BMI = weight (kg)/height 2 (m2)] (including boundary value); 3) Subjects (including male subjects and their female partners) are willing to have no fertility plan and voluntarily take effective non-drug contraceptive measures (see Appendix) from 2 weeks before screening to 6 months after the last dose and have no sperm donation and egg donation plans; 4) The subject signed a written informed consent form before screening, and fully understood the content, process and possible adverse reactions of the study, and was able to complete the study in accordance with the requirements of the protocol.

排除标准：

1) 筛选前发生或正在发生有临床表现异常需排除的疾病，包括但不限于循环系统、内分泌系统、神经系统、消化系统、呼吸系统、血液及淋巴系统、泌尿系统、内分泌系统、免疫系统疾病者，或能干扰试验结果的任何其他疾病（如：运动障碍、抽搐病史、抑郁症、闭角型青光眼等）者； 2) 既往有慢性或活动性消化道疾病者，如胃肠道穿孔、胃肠道瘘、食管疾病、胃炎、消化性溃疡、肠炎、胃食管反流、胰腺炎，活动性胃肠道出血或进行过消化道手术者，或给药前3个月内体重变化超过10%者； 3) 筛选前7天内有消化道症状（腹泻、便秘、恶心、呕吐、排便不规律，或腹泻便秘交替性发作），研究者认为不宜参加试验者； 4) 既往出现过诊断不明的皮肤病灶或黑色素瘤史者； 5) 既往有低血压病史者； 6) 既往有严重冠状动脉心脏病或不稳定型心绞痛，或最近6个月内曾发生心肌梗塞，或有失代偿性心力衰竭，或有严重心律失常，或有与心肌功能疾病相关的且与肺高压无关的先天性或获得性瓣膜缺损等心脏疾病者；或最近3个月内曾发生脑血管事件者（例如短暂性脑缺血发作、卒中）； 7) 既往有药物、食物或其他物质过敏史，易敏体质者； 8) 在筛选前3个月内接受过手术或者计划在研究期间进行手术者，及接受过会影响药物吸收、分布、代谢、排泄的手术者； 9) 筛选前14天内使用过任何处方药、非处方药、中草药、保健品和维生素者； 10) 筛选前30天内使用过任何抑制或诱导肝脏对药物代谢的药物（如：诱导剂--巴比妥类、卡马西平、苯妥英、糖皮质激素、奥美拉唑；抑制剂--SSRI类抗抑郁药、西咪替丁、地尔硫卓、大环内酯类、硝基咪唑类、镇静催眠药、维拉帕米、氟喹诺酮类、抗组胺类）；CYP2C8强效抑制剂（如吉非罗齐）者； 11) 筛选前3个月内入组了其他药物临床试验，或计划在研究期间参加其它药物临床试验者； 12) 筛选前3个月内献血包括成分血或大量失血（≥400mL）者； 13) 不能耐受静脉穿刺者，或有晕针史或晕血史者； 14) 筛选前30天内使用过口服避孕药者，或筛选前6个月内使用过长效雌激素或孕激素注射剂或埋植剂者； 15) 哺乳期和妊娠期妇女，或筛选前14天内有过无保护性行为的女性者； 16) 对饮食有特殊要求，不能接受统一饮食者，或有吞咽困难者； 17) 筛选前3个月内平均每天饮用过量茶、咖啡和/或含咖啡因的饮料（平均8杯以上，1杯≈250mL）者； 18) 筛选前3个月内平均每日吸烟量大于5支，或试验期间不能停止使用任何烟草类产品者； 19) 筛选前3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45mL酒精含量为40%的烈酒或150mL葡萄酒），或试验期间不能禁酒者； 20) 筛选前6个月内有药物滥用史者； 21) 筛选前3个月内使用过毒品者； 22) 生命体征异常有临床意义者，或体格检查、心电图、心脏彩超、实验室检查〔血常规、尿常规、血生化、血栓与止血、免疫十项、血妊娠（女性）、垂体六项、甲状腺功能、便常规〕等经研究医生判断异常有临床意义者； 23) 给药前24小时内血液酒精检测阳性者； 24) 给药前24小时内药物滥用筛查阳性者； 25) 给药前48小时内进食过可能影响药物吸收、分布、代谢、排泄的食物或饮料（包括葡萄柚、酸橙和柚子等葡萄柚相关的柑橘类水果、火龙果、芒果、杨桃、木瓜、石榴、咖啡、浓茶、巧克力等）者； 26) 研究者认为不适宜参加临床试验者。

Exclusion criteria：

1) Diseases that need to be excluded due to abnormal clinical manifestations that occur or are occurring before screening, including but not limited to circulatory system, endocrine system, nervous system, digestive system, respiratory system, blood and lymphatic system, urinary system, endocrine system, immune system diseases, or any other diseases that can interfere with the test results (such as: movement disorder, history of convulsions, depression, angle-closure glaucoma, etc.); 2) Those with chronic or active digestive tract diseases in the past, such as gastrointestinal perforation, gastrointestinal fistula, esophageal disease, gastritis, peptic ulcer, enteritis, gastroesophageal reflux, pancreatitis, active gastrointestinal bleeding or gastrointestinal surgery, or body weight change of more than 10% within 3 months before administration; 3) Those who have gastrointestinal symptoms (diarrhea, constipation, nausea, vomiting, irregular bowel movements, or alternating episodes of diarrhea and constipation) within 7 days before screening, and the investigator believes that it is not suitable to participate in the experiment; 4) Those who have had a history of skin lesions or melanoma with unknown diagnosis in the past; 5) Those with a history of hypotension in the past; 6) Those who have had severe coronary heart disease or unstable angina pectoris in the past, or have had myocardial infarction in the past 6 months, or have decompensated heart failure, or have severe arrhythmia, or have congenital or acquired valve defects and other heart diseases related to myocardial function diseases and unrelated to pulmonary hypertension, or have had cerebrovascular events (such as transient ischemic attack, stroke) in the past 3 months; 7) Those who have a history of allergies to drugs, food or other substances in the past, and are prone to allergies; 8) Those who have undergone surgery within 3 months before screening or plan to undergo surgery during the study, and those who have undergone surgery that will affect the absorption, distribution, metabolism and excretion of drugs; 9) Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products and vitamins within 14 days before screening; 10) Those who have used any drugs that inhibit or induce hepatic drug metabolism within 30 days before screening (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); strong inhibitors of CYP2C8 (such as gemfibrozil); 11) Those who have enrolled in other drug clinical trials within 3 months before screening, or plan to participate in other drug clinical trials during the study period; 12) Those who donated blood within 3 months before screening, including component blood or large blood loss (≥400mL); 13) Those who cannot tolerate venipuncture, or have a history of needle sickness or blood sickness; 14) Those who have used oral contraceptives within 30 days before screening, or those who have used long-acting estrogen or progestogen injections or implants within 6 months before screening; 15) Women who are lactating and pregnant, or women who have had unprotected sex within 14 days before screening; 16) Those who have special dietary requirements, cannot accept a unified diet, or have difficulty swallowing; 17) Those who drank excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups on average, 1 cup ≈ 250mL) per day on average within 3 months before screening; 18) Those who smoke more than 5 cigarettes per day on average within 3 months before screening, or cannot stop using any tobacco products during the trial; 19) The average weekly alcohol consumption in the 3 months before screening is greater than 14 units of alcohol (1 unit of alcohol ≈ 360mL of beer or 45mL of spirits with 40% alcohol content or 150mL of wine), or those who cannot abstain from alcohol during the trial; 20) Those who have a history of drug abuse within 6 months before screening; 21) Those who have used drugs within 3 months before screening; 22) Those with abnormal vital signs of clinical significance, or those with abnormalities of clinical significance such as physical examination, electrocardiogram, cardiac color ultrasound, laboratory tests (blood routine, urine routine, blood biochemistry, thrombosis and hemostasis, ten items of immunity, blood pregnancy (female), six items of pituitary gland, thyroid function, stool routine, etc.; 23) Those who have a positive blood alcohol test within 24 hours before administration; 24) Those who have a positive drug abuse screening within 24 hours before administration; 25) Those who have eaten food or beverages that may affect the absorption, distribution, metabolism and excretion of drugs (including grapefruit, lime and grapefruit and other grapefruit-related citrus fruits, dragon fruit, mango, star fruit, papaya, pomegranate, coffee, strong tea, chocolate, etc.) within 48 hours before administration; 26) Those who are considered by the investigator to be inappropriate to participate in clinical trials.

研究实施时间：

Study execute time：

从 From 2024-05-06 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-05-06 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

单次给药剂量组

样本量：

 52

Group：

Single Dose Group

Sample size：

干预措施：

空腹口服SYN045片(0.2,0.4,0.8,1.2,1.6, 2.2, 3mg)或安慰剂一次。

干预措施代码：

Intervention：

Orally administration of SYN045 tablets (0.2,0.4,0.8,1.2,1.6, 2.2, 3 mg) or placebo once under fasting condition.

Intervention code：

组别：

食物影响研究

样本量：

 14

Group：

Food Effect Study

Sample size：

干预措施：

其中7例在第一周期完成空腹单次给药，经过7天洗脱期，在第二周期完成高脂餐后单次给药。另7例则在第一周期完成高脂餐后单次给药，经过7天洗脱期，在第二周期完成空腹单次给药。

干预措施代码：

Intervention：

Seven of these subjects completed a single dose under fasting condition in the first cycle and, after a 7-day washout period, completed a single dose with a high-fat meal in the second cycle. The other 7 subjects completed a single dose with high-fat meal in the first cycle, followed by a 7-day washout period and completed a single dose under fasting condition in the second cycle.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽省 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 安徽医科大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Anhui Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

受试者在临床研究期间发生的任何不良事件发生率和严重程度

指标类型：

主要指标

Outcome：

Incidence and severity of any adverse events that occurred during the clinical study in the subject

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PK指标

指标类型：

次要指标

Outcome：

PK outcomes

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

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

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 45 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）：

由本次研究中随机化专员，采用SAS 9.4（或以上版本）统计软件，按区组随机的方法产生受试者随机分组的随机编码表

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

The randomization specialist in this study used SAS 9.4 (or higher version) statistical software to generate a randomized coding table for subject randomization by block randomization method

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

单次给药研究为双盲、安慰剂对照研究；食物影响研究为开放试验设计，不设盲。

Blinding：

The single dose study is a double-blind, placebo-controlled study; The study on the impact of food is an open trial design without blinding.

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）：

无

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

None

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：

电子采集和管理系统 https://edc.clinflash.com/

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

Data entry into EDC system https://edc.clinflash.com/

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-05-06 10:26:31