ChiCTR2600125998 版本V1.0 版本创建时间2026/06/02 10:38:16 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：

 ChiCTR2600125998 

最近更新日期：

Date of Last Refreshed on：

 2026-06-02 10:38:09 

注册时间：

Date of Registration：

 2026-06-02 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多次口服EVT 401片的安全性、耐受性、药代动力学、初步药效学临床研究

Public title：

A clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of multiple oral doses 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多次口服EVT 401片的安全性、耐受性、药代动力学、初步药效学临床研究

Scientific title：

A clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of multiple oral doses 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：

Wang Tenghua 

申请注册联系人电话：

Applicant telephone：

 +86 20 85959116

研究负责人电话：

Study leader's
telephone：

+86 20 85959116

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：

广东省广州市黄埔区港湾路621号

Applicant address：

No. 621, Gangwan Road, Huangpu District, Guangzhou City, Guangdong Province

Study leader's address：

No. 621, Gangwan Road, Huangpu District, Guangzhou City, Guangdong 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：

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-Y2024-112

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：

 2024-09-03 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：

广东省广州市黄埔区港湾路621号

Contact Address of the ethic committee：

No. 621, Gangwan Road, Huangpu District, Guangzhou City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 85959127

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：

广东省广州市黄埔区港湾路621号

Primary sponsor's address：

No. 621, Gangwan Road, Huangpu District, Guangzhou City, Guangdong 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)：

浙江

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

浙江金华康恩贝生物制药有限公司

具体地址：

浙江省金华市婺城区金衢路288号

Institution
hospital：

Zhejiang Jinhua Kangnai Bio-Pharmaceutical Co., Ltd.

Address：

No. 288, Jinqu Road, Wucheng District, Jinhua City, Zhejiang Province

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 Kangnai Bio-Pharmaceutical 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：

 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： 评价中国健康成年研究参与者多次口服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多剂量口服EVT 401片的药代动力学（PK）特征，为后续临床试验方案设计和用药方案提供科学依据。 次要目的： 初步评价中国健康成年研究参与者多剂量口服EVT 401片的药效学（PD）特征。  

Objectives of Study：

Main objective: To evaluate the safe dosage range and tolerability of multiple oral administrations of EVT 401 tablets by Chinese healthy adult participants, and to assess the pharmacokinetic (PK) characteristics of multiple oral doses of EVT 401 tablets by Chinese healthy adult participants, in order to provide scientific basis for the design of subsequent clinical trial protocols and medication regimens. Secondary objective: To preliminarily evaluate the pharmacodynamic (PD) characteristics of multiple oral administrations of EVT 401 tablets by Chinese healthy adult 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：

研究参与者必须满足下列标准才能被纳入试验： 1. 能够理解本研究的程序和方法、与研究者保持良好沟通，愿意严格遵守试验方案的要求和按期随访，自愿参加本研究并签署书面知情同意书； 2. 签署知情同意书时，年龄>=18 且<= 50 周岁的中国健康成年研究参与者，男女均有； 3. 筛选期，男性研究参与者体重>=50.0 kg，女性体重>=45.0 kg；体重指数（BMI）在19.0~26.0 kg/m^2范围内（含边界值：BMI=体重(kg)/身高(m^2)）； 4. 自签署知情同意书日开始至试验结束后6个月内，研究参与者确保没有生育计划，女性研究参与者无捐卵计划并同意采取可靠措施避免妊娠，男性研究参与者无捐精计划并同意采取可靠措施避免伴侣妊娠。

Inclusion criteria

The research participants must meet the following criteria to be included in the trial: 1. They must be able to understand the procedures and methods of this study, maintain good communication with the researchers, strictly abide by the requirements of the trial protocol and follow up on schedule, voluntarily participate in this study and sign a written informed consent form; 2. When signing the informed consent form, the Chinese healthy adult research participants should be aged between 18 and 50 years old (inclusive), both male and female are acceptable; 3. During the screening period, male research participants should have a weight of >= 50.0 kg, and female participants should have a weight of >= 45.0 kg; their body mass index (BMI) should be within the range of 19.0 to 26.0 kg/m^2 (including the boundary values: BMI = weight (kg) / height (m^2)); 4. From the date of signing the informed consent form until the end of the trial, the research participants must ensure that they have no fertility plans, female participants have no egg donation plans and agree to take reliable measures to avoid pregnancy, and male participants have no sperm donation plans and agree to take reliable measures to prevent their partners from getting pregnant.

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的受试者； 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，或育龄期女性受试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：

Any of the following items would be considered as exclusion criteria for this trial: 1. Individuals with any history of severe clinical diseases or those currently suffering from related diseases: (1) Including but not limited to respiratory system (such as those with a history of tuberculosis or active pulmonary tuberculosis), cardiovascular system, digestive system, urinary system, musculoskeletal system, endocrine system (such as adrenal cortical insufficiency history), nervous and mental system (such as epilepsy), blood system, immune system, etc. diseases with clinically significant anesthesia accidents history, known severe bleeding tendency conditions; (2) Genetic diseases such as malignant hyperthermia; (3) Those who had severe infections, injuries or surgeries within 12 weeks before screening and the investigator judged as not suitable for the trial; (4) Those who had acute diseases with clinically significant significance within 4 weeks before screening, such as gastrointestinal diseases, infections; (5) Those who had a history of gastroesophageal reflux for more than two weeks before screening; (6) Those who were asked to have chronic pain or were experiencing acute pain; 2. Those with a significant history of allergies, including those allergic to known drugs or any component of the trial drugs or having a history of food allergies or pollen allergies or other allergies; 3. Those who smoked more than 5 cigarettes per day or an equivalent amount of tobacco within 3 months before screening, or those who could not stop using any tobacco products during the trial; 4. Those who had a history of heavy drinking, or within 3 months before screening, had an average weekly alcohol consumption of >= 14 units (1 unit = 45 mL of strong liquor / 150 mL of wine / 350 mL of beer), or those who could not stop drinking during the trial; 5. Those who had used known drugs that cause damage to major organs within 3 months before the trial; those who used liver enzyme inducers (including phenobarbital, phenytoin sodium, rifampicin, grumet, griseofulvin, etc.) or liver enzyme inhibitors (including macrolide antibiotics, azole antifungal drugs, calcium channel antagonists, etc.) within 1 month before the trial; those who used any drugs (including any prescription drugs, over-the-counter drugs, Chinese herbal medicines) and health supplements within 2 weeks before enrollment, and the duration was shorter than 5 half-lives of the drug or less than 4 weeks (whichever is longer); unless the principal investigator and the sponsor jointly consider that the used drugs have no impact on the safety and PK/PD results of this trial, then they can be enrolled; 6. Those who could not stop consuming foods or beverages containing caffeine (such as coffee, strong tea, cola, chocolate, etc.) or other foods that affect drug absorption, distribution, metabolism, and excretion (such as dragon fruit, mango, grapefruit (citrus), tangerine, orange, rambutan, guava, etc.) within 72 hours before screening or during the study; 7. Those who participated in any drug clinical trials within 3 months before screening or planned to participate in other clinical trials during the study; 8. Those who received vaccinations (including but not limited to COVID-19, tetanus, rabies, HPV, etc.) within 2 months before screening; 9. Those who donated blood or had a large amount of blood loss (>= 400 mL) or received blood transfusion or used blood products within 30 days before screening; those who donated plasma or component blood within 7 days before screening; 10. Those with a history of fainting or hemisomnia, or those with orthostatic hypotension; 11. Those with special dietary requirements and unable to follow a unified diet; 12. Those with a history of drug abuse or drug addiction; 13. Pregnant women in lactation period, women in pregnancy period, or women of childbearing age whose blood pregnancy test is positive within 3 months before screening; 14. Those whose vital signs, physical examination, laboratory tests, electrocardiogram, chest X-ray, color ultrasound, etc. results were abnormal and judged by the investigator to have clinical significance at the time of screening. 15. Those who test positive in the urine drug screening or have a positive result in the alcohol breath test before entering the Phase I clinical research ward; 16. Those who, in the opinion of the researchers, have other factors that make them unsuitable to participate in the trial.

研究实施时间：

Study execute time：

从 From 2024-09-18 00:00:00至 To 2025-05-29 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-09-19 00:00:00 至 To 2024-11-28 00:00:00

干预措施：

Interventions：

组别：

药物组

样本量：

 24

Group：

Investigational Group

Sample size：

干预措施：

EVT 401片剂

干预措施代码：

Intervention：

EVT 401 Tablets

Intervention code：

组别：

安慰剂组

样本量：

 6

Group：

Placebo Group

Sample size：

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：

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, Grade4, 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：

多次给药试验计划在给药前后采集每名研究参与者的静脉血共计36个样本或37个样本进行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：

MAD：36/37 venous blood samples (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：

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.

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：

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）：

试验中各剂量组分别随机，由研究者为已签署知情同意的研究参与者分配筛选号，筛选号由S+三位阿拉伯数字构成。研究参与者筛选合格之后按照筛选号从小到大获得随机号，随机号由四位数字组成，第一位数代表为剂量组号，后三位数代表组内顺序号。

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

In the trial, randomization will be performed separately for each dose group. The investigator will assign a screening number to each study participant who has signed the informed consent form. The screening number consists of the letter 'S' followed by three Arabic numerals. After a study participant is deemed eligible for the trial, they will receive a randomization number in ascending order of their screening number. The randomization number consists of four digits, with the first digit representing the dose group number and the last three digits representing the sequential number within the group.

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，对研究参与者和研究者设盲

Blinding：

Double-blind, with both the research participants and the researchers being blinded.

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）：

研究结束后，通过ResMan(www.medresman.org.cn)方式共享

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

,ResMan(www.medresman.org.cn)

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：

EDC

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

  2026-06-02 10:38:09