ChiCTR2500114353 版本V1.0 版本创建时间2025/12/10 17:03:08 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：

 ChiCTR2500114353 

最近更新日期：

Date of Last Refreshed on：

 2025-12-10 17:01:50 

注册时间：

Date of Registration：

 2025-12-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

HRS-6257在健康受试者中单/多次给药的安全性、耐受性、药代动力学、药效动力学及食物影响研究

Public title：

Study on the safety, tolerability, pharmacokinetics, pharmacodynamics, and food influence of single/multiple dosing of HRS-6257 in healthy subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

HRS-6257在健康受试者中单/多次给药的安全性、耐受性、药代动力学、药效动力学及食物影响研究

Scientific title：

Study on the safety, tolerability, pharmacokinetics, pharmacodynamics, and food influence of single/multiple dosing of HRS-6257 in healthy subjects

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：

黄洁 

研究负责人：

阳国平 

Applicant：

Jie Huang 

Study leader：

Yang Guoping 

申请注册联系人电话：

Applicant telephone：

 +86 731 8991 8665

研究负责人电话：

Study leader's
telephone：

+86 731 8861 8938

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：

 cellahuang1988@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ygp9880@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：

中国湖南省长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Applicant address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

Study leader's address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China 14/5000 AI No. 138, Tongzipo Road, Yuelu District, Changsha City

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：

中南大学湘雅三医院临床试验研究中心

Applicant's institution：

Clinical Trial Research Center, Xiangya Third Hospital, Central South University

研究负责人所在单位：

中南大学湘雅三医院

Affiliation of the Leader：

Xiangya Third Hospital, Central South 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：

 25184

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：

中南大学湘雅三医院伦理委员会

Name of the ethic committee：

Ethics Committee of Xiangya Third Hospital, Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-10-22 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Xiaomin Wang

伦理委员会联系地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Contact Address of the ethic committee：

138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 8861 8938

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：

中南大学湘雅三医院

Primary sponsor：

Xiangya Third Hospital, Central South University

研究实施负责（组长）单位地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, 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)：

湖南

市(区县)：

长沙

Country：

China

Province：

Human

City：

Changsha

单位(医院)：

中南大学湘雅三医院

具体地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Institution
hospital：

Xiangya Third Hospital, Central South University

Address：

138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

经费或物资来源：

上海恒瑞医药有限公司

Source(s) of funding：

Shanghai Hengrui Pharmaceutical Co., Ltd

研究疾病：

疼痛  

Target disease：

Pain

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 评价健康受试者单次口服HRS-6257后的安全性和耐受性。 次要目的 评价健康受试者单次空腹口服HRS-6257的药代动力学特征。 评价食物对HRS-6257的药代动力学特征的影响。 评价HRS-6257对健康受试者QTc间期的影响。  

Objectives of Study：

Main purpose Evaluate the safety and tolerability of HRS-6257 after a single oral administration in healthy subjects. Secondary objective Evaluate the pharmacokinetic characteristics of a single oral administration of HRS-6257 in healthy subjects on an empty stomach. Evaluate the impact of food on the pharmacokinetic characteristics of HRS-6257. Evaluate the impact of HRS-6257 on the QTc interval in healthy subjects.

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.签署知情同意书时年龄介于18~55周岁（含边界值），男女均可； 2.筛选期男性体重>=50 kg，女性体重>=45 kg，体重指数（BMI＝体重(kg)/身高^2(m^2)）介于19 ~28 kg/m^2（含边界值）； 3.受试者及其伴侣自签署知情同意书至末次接受试验药物后2个月内无生育、捐精、捐卵计划，且自愿采取高效避孕措施（见第13.1.2节）；有生育能力的女性受试者必须在筛选期和基线期进行血清妊娠试验，且结果为阴性； 4.女性受试者：非妊娠期或哺乳期； 5.接受疼痛刺激部位的皮肤无伤口或皮肤病； 6.愿意接受疼痛试验且培训合格者； 7.受试者在试验前已经详细了解试验性质、意义、可能的获益，可能带来的不便和潜在的风险与不适，能够理解本研究的程序和方法，愿意严格遵守整个临床研究的要求，并自愿签署知情同意书。

Inclusion criteria

1.When signing the informed consent form, the age range is between 18 and 55 years old (including the threshold), and both males and females are eligible; 2. During the screening period, male weight >= 50 kg, female weight >= 45 kg, and body mass index (BMI=weight (kg)/height ^2 (m^2)) between 19-28 kg/m^2 (including boundary values); 3. The subjects and their partners have no plans to conceive, donate sperm, or eggs within 2 months after signing the informed consent form until the last time they received the investigational drug, and voluntarily adopt efficient contraceptive measures (see Section 13.1.2); Female subjects with fertility must undergo serum pregnancy tests during the screening and baseline periods, and the results must be negative; 4. Female subjects: non pregnant or lactating; 5. The skin of the area receiving pain stimulation has no wounds or skin diseases; 6. Willing to undergo pain testing and pass training; 7.The subjects have a detailed understanding of the nature, significance, potential benefits, potential inconveniences, risks, and discomfort of the trial before the trial, are able to understand the procedures and methods of this study, are willing to strictly comply with the requirements of the entire clinical study, and voluntarily sign an informed consent form.

排除标准：

1.既往或目前患有循环系统、内分泌系统、神经系统、消化系统、呼吸系统、血液学、免疫学、精神病学及代谢异常等临床急慢性疾病，经研究者判定不适宜入组者； 2.筛选期或基线期：天门冬氨酸氨基转移酶、丙氨酸氨基转移酶、总胆红素、血肌酐超过正常范围上限者，QTcF＞450 ms者，或经研究者判定异常且有临床意义的高钾血症、低钾血症者； 3.既往有尖端扭转型室性心动过速病史、症状性室性心律失常，或有短QT综合征、长 QT 综合征个人史或家族史者； 4.既往有溶血性疾病、G6PD缺乏症和地中海贫血等血红蛋白异常疾病以及贫血性疾病受试者； 5.已知对研究药物或研究药物的辅料有过敏史者、既往有慢性荨麻疹、严重过敏反应病史、 或过敏体质者（对2种及以上药物及食物过敏）； 6.既往有遗传性血管性水肿史及家族史者； 7.筛选前6个月内接受过重大手术者，或既往接受过可能显著影响研究药物药动学特征或安全性评价的手术者（如胃切除术、肝肾移植术），或计划在试验期间进行手术者； 8.给药前1个月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）者； 9.筛选前1个月内接种过疫苗或计划在试验期间接种疫苗者； 10.给药前7个半衰期内或14天内（以时间较长者为准）使用过任何药物或保健品（包括中草药）者，或筛选期已知试验期间可能需要接受其他药物治疗者； 11.筛选前3个月内参加过临床试验并接受了试验药物者，或计划在试验期间参加其他临床试验者； 12.筛选前6个月内献血/失血量>=200 mL（女性生理性失血除外）、接受输血或使用血制品，或计划在试验期间或试验结束后1个月内献血者； 13.筛选前3个月内平均每日吸烟量大于5支，或试验期间不能戒烟者； 14.筛选前3个月内平均每周饮酒超过14单位酒精（1单位≈285?mL酒精含量为3.5%的啤酒，或25?mL酒精含量为40%的烈酒，或85?mL酒精含量为12%的葡萄酒），或不同意试验期间禁酒者； 15.筛选前3个月内每天饮用过量茶、咖啡或含咖啡因的饮料（平均每天8杯以上，1杯=200 mL）者； 16.给药前48小时内食用特殊食物（如西柚、西柚汁或含西柚汁的食物/饮料、巧克力、烟草、酒精类、含咖啡因类等食物或饮料）者； 17.对饮食有特殊要求，不能遵守统一饮食者； 18.筛选期或基线期体检结果经研究医生判断为异常有临床意义者； 19.乙肝表面抗原、丙型肝炎病毒抗体、梅毒或人类免疫缺陷病毒抗体检查有一项或一项以上呈阳性者； 20.有药物滥用史或药物滥用筛查呈阳性者； 21.酒精呼气筛查结果为阳性者； 22.吞咽困难者，或静脉采血困难/不能耐受静脉穿刺者，或有晕针/晕血史者； 23.受试者可能因为其他原因而不能完成本研究或研究者认为不适合纳入者（如评估认为受试者对疼痛过于敏感或者极不敏感）。

Exclusion criteria：

1. Those who have previously or currently suffered from clinical acute or chronic diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, and have been determined by researchers to be unsuitable for inclusion; 2. Screening period or baseline period: For patients with aspartate aminotransferase, alanine aminotransferase, total bilirubin, and serum creatinine exceeding the upper limit of the normal range, QTcF>450 ms, or those with clinically significant hyperkalemia or hypokalemia determined by researchers to be abnormal; 3. Individuals with a history of apical torsion type ventricular tachycardia, symptomatic ventricular arrhythmia, or a personal or family history of short QT syndrome or long QT syndrome; 4. Subjects with hemoglobin abnormalities such as hemolytic disease, G6PD deficiency, and thalassemia, as well as anemic diseases in the past; 5. Individuals with a known history of allergies to the investigational drug or its excipients, a history of chronic urticaria, severe allergic reactions, or an allergic constitution (allergic to two or more drugs and food); 6. Individuals with a history of hereditary angioedema and family history; 7. Select patients who have undergone major surgeries within the previous 6 months, or who have undergone surgeries that may significantly affect the pharmacokinetic characteristics or safety evaluation of the study drug (such as gastrectomy, liver and kidney transplantation), or who plan to undergo surgery during the trial period; 8. Those who have used any drugs that inhibit or induce liver metabolism of drugs (such as inducers barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedative hypnotic drugs, verapamil, fluoroquinolones, antihistamines) within one month before administration; 9. Select individuals who have received the vaccine within the previous month or plan to receive the vaccine during the trial period; 10. Those who have used any medication or health supplement (including Chinese herbal medicine) within the first 7 half lives or 14 days (whichever is longer) before administration, or those who may need to receive other medication treatment during the screening period known to be the trial period; 11. Select individuals who have participated in clinical trials and received the investigational drug within the previous 3 months, or who plan to participate in other clinical trials during the trial period; 12. Select individuals who have donated blood/lost blood >= 200 mL within the first 6 months (excluding physiological bleeding in females), received blood transfusions or used blood products, or plan to donate blood during the trial period or within 1 month after the trial ends; 13. Select individuals who have smoked an average of more than 5 cigarettes per day within the past 3 months, or who are unable to quit smoking during the trial period; 14. Select individuals who have consumed an average of more than 14 units of alcohol per week within the previous 3 months (1 unit ≈ 285 mL of beer with an alcohol content of 3.5%, or 25 mL of strong liquor with an alcohol content of 40%, or 85 mL of wine with an alcohol content of 12%), or who do not agree to abstain from alcohol during the trial period; 15. Screening for individuals who have consumed excessive amounts of tea, coffee, or caffeinated beverages daily within the past 3 months (an average of 8 or more cups per day, 1 cup=200 mL); 16. Those who consume special foods (such as grapefruit, grapefruit juice, or foods/beverages containing grapefruit juice, chocolate, tobacco, alcohol, caffeine, etc.) within 48 hours before administration; 17. Those who have special dietary requirements and cannot follow a uniform diet; 18. If the screening or baseline physical examination results are judged by the research doctor to be abnormal and clinically significant; 19. One or more positive tests for hepatitis B surface antigen, hepatitis C virus antibody, syphilis or human immunodeficiency virus antibody; 20. Individuals with a history of drug abuse or who have tested positive for drug abuse screening; 21. Individuals with positive results in alcohol breath screening; 22. People with swallowing difficulties, or those who have difficulty with venous blood collection/cannot tolerate venipuncture, or those with a history of needle/blood dizziness; 23.Participants may not be able to complete this study for other reasons or may be deemed unsuitable for inclusion by the researcher (such as being assessed as overly sensitive or extremely insensitive to pain).

研究实施时间：

Study execute time：

从 From 2025-10-27 00:00:00至 To 2027-10-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-15 00:00:00 至 To 2026-10-30 00:00:00

干预措施：

Interventions：

组别：

Part1 25mg

样本量：

 10

Group：

Part1 25mg

Sample size：

干预措施：

空腹单次给药HRS6257 片25mg或安慰剂。8 例接受 HRS-6257，2 例接受安慰剂。

干预措施代码：

Intervention：

Single oral administration of 25mg HRS6257 tablets or placebo under fasting conditions. 8 cases received HRS-6257, and 2 cases received a placebo.

Intervention code：

组别：

Part1 50mg

样本量：

 10

Group：

Part1 50mg

Sample size：

干预措施：

空腹单次给药HRS6257 片50mg或安慰剂。8 例接受 HRS-6257，2 例接受安慰剂。

干预措施代码：

Intervention：

Single oral administration of 50mg HRS6257 tablets or placebo under fasting conditions. 8 cases received HRS-6257, and 2 cases received a placebo.

Intervention code：

组别：

Part1 100mg

样本量：

 10

Group：

Part1 100mg

Sample size：

干预措施：

受试者共需给药2次，第一周期空腹给药HRS6257 片100mg或安慰剂，第二周期餐后给药HRS6257 片100mg或安慰剂，周期间清洗期为7天。8 例接受 HRS-6257，2 例接受安慰剂。

干预措施代码：

Intervention：

Subjects will receive a total of 2 administrations. In the first period, they will be given 100mg HRS6257 tablets or placebo under fasting conditions; in the second period, they will be given 100mg HRS6257 tablets or placebo after meals. The washout period between the two periods is 7 days. 8 cases received HRS-6257, and 2 cases received a placebo.

Intervention code：

组别：

Part1 200mg

样本量：

 10

Group：

Part1 200mg

Sample size：

干预措施：

空腹单次给药HRS6257 片50mg或安慰剂。8 例接受 HRS-6257，2 例接受安慰剂。

干预措施代码：

Intervention：

Single oral administration of 200mg HRS6257 tablets or placebo under fasting conditions.8 cases received HRS-6257, and 2 cases received a placebo.

Intervention code：

组别：

Part1 400mg

样本量：

 10

Group：

Part1 400mg

Sample size：

干预措施：

空腹单次给药HRS6257 片400mg或安慰剂。8 例接受 HRS-6257，2 例接受安慰剂。

干预措施代码：

Intervention：

Single oral administration of 400mg HRS6257 tablets or placebo under fasting conditions.8 cases received HRS-6257, and 2 cases received a placebo.

Intervention code：

组别：

Part2 25mg

样本量：

 10

Group：

Part2 25mg

Sample size：

干预措施：

受试者于D1~D14早、晚分别空腹给药1次HRS6257 片25mg或安慰剂（D14仅早晨给药），每次给药间隔12 h，共计给药27次。8 例接受 HRS-6257，2 例接受安慰剂。

干预措施代码：

Intervention：

Subjects will receive 25mg HRS6257 tablets or placebo once each in the morning and evening under fasting conditions from Day 1 to Day 14 (only one dose will be administered in the morning on Day 14), with an interval of 12 hours between each dose, totaling 27 administrations. 8 cases received HRS-6257, and 2 cases received a placebo.

Intervention code：

组别：

Part2 50mg

样本量：

 10

Group：

Part2 50mg

Sample size：

干预措施：

受试者于D1~D14早、晚分别空腹给药1次HRS6257 片50mg或安慰剂（D14仅早晨给药），每次给药间隔12 h，共计给药27次。8 例接受 HRS-6257，2 例接受安慰剂。

干预措施代码：

Intervention：

Subjects will receive 50mg HRS6257 tablets or placebo once each in the morning and evening under fasting conditions from Day 1 to Day 14 (only one dose will be administered in the morning on Day 14), with an interval of 12 hours between each dose, totaling 27 administrations. 8 cases received HRS-6257, and 2 cases received a placebo.

Intervention code：

组别：

Part2 100mg

样本量：

 10

Group：

Part2 100mg

Sample size：

干预措施：

受试者于D1~D14早、晚分别空腹给药1次HRS6257 片100mg或安慰剂（D14仅早晨给药），每次给药间隔12 h，共计给药27次。8 例接受 HRS-6257，2 例接受安慰剂。

干预措施代码：

Intervention：

Subjects will receive 100mg HRS6257 tablets or placebo once each in the morning and evening under fasting conditions from Day 1 to Day 14 (only one dose will be administered in the morning on Day 14), with an interval of 12 hours between each dose, totaling 27 administrations. 8 cases received HRS-6257, and 2 cases received a placebo.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China

Province：

Human

City：

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三甲 

Institution
hospital：

Third Xiangya Hospital, Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

12导联心电图指标

指标类型：

主要指标

Outcome：

12 lead electrocardiogram indicators

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生命体征

指标类型：

主要指标

Outcome：

Vital signs

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

动态心电图指标

指标类型：

主要指标

Outcome：

Holter monitor indicators

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

指标类型：

次要指标

Outcome：

Pharmacokinetics

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛阈值

指标类型：

次要指标

Outcome：

Pain threshold

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

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 55 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）：

本研究采用区组随机化方法。每组计划入选10例受试者，按照4:1的比例分配到2个治疗组别（即HRS-6257组8例、安慰剂组2例）。随机化专员采用SAS软件完成随机分配表与药物编号表的产生，中央随机化系统对符合随机标准的受试者进行随机分组、分配随机号，并根据入组结果给予受试者相应组别的药物。

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

This study used block randomization method. Each group plans to select 10 subjects, who will be allocated to two treatment groups in a 4:1 ratio (8 in HRS-6257 group and 2 in placebo group). The randomization specialist uses SAS software to generate the random allocation table and drug number table. The central randomization system randomly groups and assigns random numbers to subjects who meet the randomization criteria, and provides corresponding drugs to the subjects based on the enrollment results.

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：

除事先规定的非盲人员以外，其他相关人员如受试者、研究者、所有参与试验或临床评定的医务人员、参与本试验的监查员、医学经理、安全经理、统计师、医学总监等以及第三方合同试验机构（PK 浓度检测机构除外）相关人员对受试者接受何种试验用药品均不知情。

Blinding：

Except for non-blinded personnel specified in advance, other relevant personnel such as subjects, researchers, all medical staff involved in the trial or clinical evaluation, monitors participating in the trial, medical managers, safety managers, statisticians, medical directors, and personnel from third-party contract research organizations (excluding PK concentration testing agencies) are all unaware of which investigational drug the subjects are receiving.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

https://www.trialos.com.cn/login/

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

https://www.trialos.com.cn/login/

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：

数据采集：由研究者或其授权的CRC通过独立的账号进入数据管理系统，进行数据采集。 数据管理：数据管理员根据方案设计eCRF，eCRF中包含除外部数据外方案中规定的全部数据点。由EDC系统直接导出eCRF（PDF格式）。

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

Data collection: Researchers or their authorized clinical research coordinators (CRCs) access the data management system through independent accounts to conduct data collection. Data management: Data managers design the electronic case report forms (eCRF) according to the protocol. The eCRF contains all the data points specified in the protocol except for external data. The eCRF (in PDF format) is directly exported from the Electronic Data Capture (EDC) system.

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：

  2025-12-10 17:01:50