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：	ChiCTR2600126139
最近更新日期： Date of Last Refreshed on：	2026-06-04 12:03:44
注册时间： Date of Registration：	2026-06-04 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	在中国健康成年研究参与者中评价单次口服EVT 401片的安全性、耐受性、药代动力学、初步药效学及食物影响的临床研究
Public title：	A clinical study to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, and food effect of a single oral dose of EVT 401 tablets in healthy Chinese adult participants
注册题目简写：
English Acronym：
研究课题的正式科学名称：	在中国健康成年研究参与者中评价单次口服EVT 401片的安全性、耐受性、药代动力学、初步药效学及食物影响的临床研究
Scientific title：	A clinical study to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, and food effect of a single oral dose of EVT 401 tablets in healthy Chinese adult participants
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：	王腾华	研究负责人：	王腾华
Applicant：	Wang Tenghua	Study leader：	Tenghua Wang
申请注册联系人电话： Applicant telephone：	+86 20 8595 9116	研究负责人电话： Study leader's telephone：	+86 20 8595 9116
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：	wangtenghua88@126.com	研究负责人电子邮件： Study leader's E-mail：	wangtenghua88@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：	广东省广州市黄埔区港湾路621号	研究负责人通讯地址：	广州市黄埔区港湾路621号
Applicant address：	No. 621, Gangwan Road, Huangpu District, Guangzhou City, Guangdong Province, China	Study leader's address：	No. 621 Gangwan Road, Huangpu District, Guangzhou
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：	广州医科大学附属第五医院
Applicant's institution：	The Fifth Affiliated Hospital of Guangzhou Medical University
研究负责人所在单位：	广州医科大学附属第五医院
Affiliation of the Leader：	The Fifth Affiliated Hospital of Guangzhou 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：	GYWY-Y2022-93	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：	广州医科大学附属第五医院伦理委员会
Name of the ethic committee：	The Fifth Affiliated Hospital of Guangzhou Medical University Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2022-07-27 00:00:00
伦理委员会联系人：	周绮汶
Contact Name of the ethic committee：	Zhou Qiwen
伦理委员会联系地址：	广州市黄埔区港湾路621号
Contact Address of the ethic committee：	No. 621 Gangwan Road, Huangpu District, Guangzhou
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 20 8595 9127	伦理委员会联系人邮箱： Contact email of the ethic committee：	GYWYLLWYH@126.com

研究实施负责（组长）单位：

广州医科大学附属第五医院

Primary sponsor：

The Fifth Affiliated Hospital of Guangzhou Medical University

研究实施负责（组长）单位地址：

广州市黄埔区港湾路621号

Primary sponsor's address：

No. 621 Gangwan Road, Huangpu District, Guangzhou

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)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	广州医科大学附属第五医院	具体地址：	广州市黄埔区港湾路621号
Institution hospital：	The Fifth Affiliated Hospital of Guangzhou Medical University	Address：	No. 621 Gangwan Road, Huangpu District, Guangzhou

经费或物资来源：

浙江金华康恩贝生物制药有限公司

Source(s) of funding：

Zhejiang Jinhua CONBA Bio-pharm. Co., Ltd.

研究疾病：

类风湿关节炎

Target disease：

Rheumatoid Arthritis

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：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

主要目的：评价中国健康成年研究参与者单次口服EVT 401片后的安全剂量范围和耐受性，评价中国健康成年研究参与者单剂量口服EVT 401片的药代动力学（PK）特征，为后续临床试验方案设计提供科学依据。次要目的：初步评价中国健康成年研究参与者单剂量口服EVT 401片的药效学（PD）特征。评价食物对中国健康成年研究参与者单剂量口服EVT 401片的药代动力学（PK）影响。

Objectives of Study：

Primary Objectives:To evaluate the safety dose range and tolerability of a single oral dose of EVT 401 tablets in healthy Chinese adult study participants.To evaluate the pharmacokinetic (PK) profile of a single oral dose of EVT 401 tablets in healthy Chinese adult study participants, thereby providing scientific evidence to support the design of subsequent clinical trial protocols. Secondary Objectives:To preliminarily evaluate the pharmacodynamic (PD) profile of a single oral dose of EVT 401 tablets in healthy Chinese adult study participants.To evaluate the effect of food on the pharmacokinetic (PK) profile of a single oral dose of EVT 401 tablets in healthy Chinese adult study participants.

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

Study participants must meet all of the following criteria to be enrolled in the trial: 1.Be capable of understanding the procedures and methods of this study:
1. Ability to understand the procedures and methods of this study, maintain good communication with the investigator, willingness to strictly comply with the requirements of the clinical trial protocol and scheduled follow-ups, and voluntary participation in this study with written informed consent signed;  
2. Chinese healthy adult participants, both male and female, aged >=18 and <=50 years at the time of signing the informed consent form;  
3. During the screening period, male participants with body weight >=50.0 kg, female participants with body weight >=45.0 kg; Body Mass Index (BMI) within the range of 19.0–26.0 kg/m^2 (including boundary values; BMI = body weight (kg) / height (m^2));  
4. From the signing of the informed consent form until 6 months after the end of the trial, participants must ensure no plans for procreation. Female participants must have no egg donation plan and agree to take reliable measures to avoid pregnancy; male participants must have no sperm donation plan and agree to take reliable measures to avoid pregnancy in their partners.

排除标准：

下述任何一项都属于本试验的排除标准： 1. 有任何临床严重疾病史或目前正在罹患相关疾病者： (1) 包括但不限于呼吸系统（如既往有结核病史或活动性肺结核病史者）、心血管系统、消化系统、泌尿系统、肌肉骨骼系统、内分泌系统（如肾上腺皮质功能不全病史）、神经精神系统（如癫痫）、血液系统、免疫系统等系统的疾病，有临床意义的麻醉意外史、已知的严重出血倾向情况； (2) 恶性高热等遗传病史； (3) 筛选前 12 周有严重感染、外伤或进行过手术且研究者判断不适合试验； (4) 筛选前 4 周内出现具有临床显著意义的急性疾病，如胃肠道疾病、感染； (5) 筛选前 3 个月内有超过两周胃食管反流史； (6) 经询问存在慢性疼痛或正在经历急性疼痛（指持续时间少于 3 个月的疼痛）的研究参与者； 2. 既往有显著过敏史者，包括对已知药物或试验药物任一组分过敏者或食物过敏史或花粉过敏史者或其他过敏者； 3. 经询问，筛选期前 3 个月内，吸烟超过 5 支/日或等量烟草者，或在试验期间不能停止任何烟草类产品者； 4. 经询问，曾有酗酒史，或筛选期前 3 个月内，平均饮酒每周 >=14 个单位（1 单位 = 45 mL 高度白酒 / 150 mL 葡萄酒 / 350 mL 啤酒），或试验期间不能禁酒者； 5. 试验前 3 个月内用过已知对主要脏器有损害的药物者；筛选前 1 个月内使用过肝药酶诱导剂（包括苯巴比妥、苯妥英钠、利福平、格鲁米特、灰黄霉素等）、肝药酶抑制剂（包括大环内酯类抗生素、唑类抗真菌药、钙离子拮抗剂等）者；入组前 2 周内使用过任何药物（包括任何处方药、非处方药、中草药）及保健品者，且时间短于药物 5 个半衰期或小于 4 周者（以二者中时间最长者为准）；除非主要研究者和申办者共同认为所用药物对本试验安全性和 PK/PD 结果没有影响方可入组； 6. 筛选前 72 小时内，或研究期间无法停止食用含有咖啡因的食物或饮料（如咖啡、浓茶、可乐、巧克力等），或其他影响药物吸收、分布、代谢、排泄的食品（如火龙果、芒果、葡萄柚（西柚）、柚子、橘子、杨桃、番石榴等）； 7. 筛选前 3 个月内参加了任何药物临床试验者，或计划在研究期间参与其他临床试验者； 8. 筛选前 2 个月内接种疫苗（包括但不限于新冠、破伤风、狂犬、HPV 等疫苗）者； 9. 筛选前 3 个月内献血或大量失血（>=400 mL）或接受输血或使用血制品者；筛选前 30 天内献血或失血 >=200 mL 者；筛选前 7 天内献血浆、成分血者； 10. 有晕针、晕血史，或有体位性低血压者； 11. 对饮食有特殊要求，不能遵守统一饮食者； 12. 有吸毒史或药物滥用史者； 13. 哺乳期、妊娠期妇女，或育龄期女性研究参与者血妊娠检查为阳性者； 14. 筛选时的生命体征、体格检查、实验室检查、心电图、胸部 X 片、彩超等结果异常且经研究者判断有临床意义者； 15. 入住 I 期临床研究病房前，尿药筛检查阳性者或酒精呼气检查呈阳性者； 16. 研究者认为有不适合参加试验的其他因素者。

Exclusion criteria：

Study participants who meet any of the following criteria will be excluded from the trial : 1. Have a history of any clinically significant disease or are currently suffering from related diseases: (1) Including but not limited to diseases of the respiratory system (e.g., history of tuberculosis or active pulmonary tuberculosis), cardiovascular system, digestive system, urinary system, musculoskeletal system, endocrine system (e.g., history of adrenocortical insufficiency), neurological and psychiatric system (e.g., epilepsy), hematological system, immune system, etc.; (2) History of clinically significant anesthesia accidents; (3) Known severe bleeding tendency; (4) History of genetic diseases such as malignant hyperthermia; (5) Severe infection, trauma, or surgery within 12 weeks prior to screening that, in the investigator's judgment, makes the participant unsuitable for the trial; (6) Occurrence of clinically significant acute diseases, such as gastrointestinal diseases or infections, within 4 weeks prior to screening; (7) History of gastroesophageal reflux disease for more than two weeks within 3 months prior to screening; (8) Study participants with chronic pain or experiencing acute pain (referring to pain lasting less than 3 months) upon inquiry; 2. Have a history of significant allergies, including known allergies to any drug or any component of the investigational drug, history of food allergies, pollen allergies, or other allergies; 3. Upon inquiry, have smoked more than 5 cigarettes per day or an equivalent amount of tobacco within 3 months prior to the screening period, or are unable to refrain from using any tobacco products during the trial period; 4. Upon inquiry, have a history of alcohol abuse, or have an average weekly alcohol consumption of >=14 units within 3 months prior to the screening period (1 unit = 45 mL of high-proof liquor / 150 mL of wine / 350 mL of beer), or are unable to abstain from alcohol during the trial period; 5. Have used drugs known to cause damage to major organs within 3 months prior to the trial; have used hepatic enzyme inducers (including phenobarbital, phenytoin sodium, rifampicin, glutethimide, griseofulvin, etc.) or hepatic enzyme inhibitors (including macrolide antibiotics, azole antifungals, calcium channel blockers, etc.) within 1 month prior to screening; have used any medication (including any prescription drugs, over-the-counter drugs, herbal medicines) or health supplements within 2 weeks prior to enrollment, and the time is less than 5 half-lives of the drug or less than 4 weeks (whichever is longer); unless both the principal investigator and the sponsor agree that the medication used has no impact on the safety and PK/PD results of this trial, enrollment may be permitted; 6. Have consumed, within 72 hours prior to screening, or are unable to refrain from consuming during the study, foods or beverages containing caffeine (such as coffee, strong tea, cola, chocolate, etc.), or other foods that affect drug absorption, distribution, metabolism, or excretion (such as dragon fruit, mango, grapefruit, pomelo, orange, star fruit, guava, etc.); 7. Have participated in any drug clinical trial within 3 months prior to screening, or plan to participate in other clinical trials during the study period; 8. Have received vaccination (including but not limited to COVID-19, tetanus, rabies, HPV vaccines, etc.) within 2 months prior to screening; 9. Have donated blood or experienced significant blood loss (>=400 mL), or received blood transfusion or used blood products within 3 months prior to screening; have donated blood or experienced blood loss >=200 mL within 30 days prior to screening; have donated plasma or blood components within 7 days prior to screening; 10. Have a history of needle syncope, blood syncope, or orthostatic hypotension; 11. Have special dietary requirements and are unable to comply with a unified diet; 12. Have a history of drug abuse or substance abuse; 13. Are lactating, pregnant, or female participants of childbearing potential with a positive blood pregnancy test; 14. Have vital signs, physical examination findings, laboratory test results, electrocardiogram (ECG), chest X-ray, or color Doppler ultrasound findings at screening that are abnormal and considered clinically significant by the investigator; 15. Have a positive urine drug screen test or a positive alcohol breath test result before admission to the Phase I clinical trial ward; 16. Have any other factors that, in the investigator's judgment, make the participant unsuitable for participation in the trial.

研究实施时间：

Study execute time：

从 From 2023-08-30 00:00:00至 To 2024-11-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-08-31 00:00:00 至 To 2024-05-14 00:00:00

干预措施：

Interventions：

组别：	药物组	样本量：	42
Group：	Investigational Group	Sample size：	42
干预措施：	EVT 401片剂	干预措施代码：
Intervention：	EVT 401 Tablets	Intervention code：

组别：	餐后组	样本量：	14
Group：	Fasted Group	Sample size：	14
干预措施：	餐后口服EVT401片剂	干预措施代码：
Intervention：	EVT 401 Tablets (Fed)	Intervention code：

组别：	空腹组	样本量：	14
Group：	Fasted Group	Sample size：	14
干预措施：	空腹口服EVT401片剂	干预措施代码：
Intervention：	EVT 401 Tablets (Fasted)	Intervention code：

组别：	对照组	样本量：	13
Group：	Placebo Group	Sample size：	13
干预措施：	EVT 401片模拟剂	干预措施代码：
Intervention：	EVT 401 Placebo	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	广州医科大学附属第五医院	单位级别：	三级甲等
Institution hospital：	The Fifth Affiliated Hospital of Guangzhou Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	EVT401 PD 参数	指标类型：	次要指标
Outcome：	PD parameters of EVT401	Type：	Secondary indicator
测量时间点：	单次给药试验计划采集每名研究参与者各5个PD静脉血样本。	测量方法：	使用流式细胞术检测细胞亚群，使用多功能流式点阵技术检测细胞因子。
Measure time point of outcome：	SAD: 5 venous blood samples；(per participant)	Measure method：	Cell subsets will be detected using flow cytometry, and cytokines will be detected using multiplex flow cytometry technology

指标中文名：	不良事件、不良反应、严重不良事件的发生率	指标类型：	主要指标
Outcome：	Incidence of Adverse Events,Adverse Reactions,Serious Adverse Events	Type：	Primary indicator
测量时间点：	观察所有受试者在临床研究期间发生的任何不良事件	测量方法：	按照SOC和PT的不同严重程度（1级、2级、3级、4级、5级）对各类TEAE进行归纳总结，计算例数、例次和发生率。
Measure time point of outcome：	All adverse events that occur in any subject during the clinical study will be observed.	Measure method：	Summarize various treatment-emergent adverse events (TEAEs) by System Organ Class (SOC) and Preferred Term (PT), stratified by severity (Grade 1, Grade 2, Grade 3, Grade 4, Grade 5). Calculate the number of subjects affected, the number of events, and the incidence rate.

指标中文名：	EVT401 PK 参数	指标类型：	次要指标
Outcome：	PK parameters of EVT401	Type：	Secondary indicator
测量时间点：	单次给药试验计划采集采集每名研究参与者共计19个PK静脉血样本，11个时间段的尿液样本。食物影响试验计划21个时间点采集血样进行PK研究。	测量方法：	样本分别采用经过验证合格的液相色谱-质谱/质谱( LC-MS / MS )方法进行测定。
Measure time point of outcome：	SAD: 19 venous blood samples, 11 urine samples；FE: 21 venous blood sample；(per participant)	Measure method：	The samples will be analyzed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.

指标中文名：	药代动⼒学（PK）指标	指标类型：	主要指标
Outcome：	Pharmacokinetic (PK) Parameters	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	药效动⼒学（PD）探索性指标	指标类型：	主要指标
Outcome：	Pharmacodynamic (PD) Exploratory Parameters	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：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	50	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）：

采用区组随机化方法，由统计单位采用SAS（9.4或更高版本）软件生成随机号及其对应的组别（SAD试验：试验药或安慰剂，FE试验：空腹-餐后组或餐后-空腹组）

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

A block randomization method will be adopted in the trial. The statistics unit use SAS (version 9.4 or higher) software to generate the randomization numbers and their corresponding group assignments (for the SAD trial: investigational drug or placebo; for the FE trial: fasting-fed group or fed-fasting group). The block length, seed number, and SAS program set during the randomization process will be preserved together in the randomization process records to ensure the reproducibility of the randomization code.

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：	双盲
Blinding：	Double blind

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）：	国家生物信息中心 China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/).
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(Electronic Data Capture,EDC）
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Electronic Data Capture,EDC
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-06-04 12:03:24