ChiCTR2500115630 版本V1.0 版本创建时间2025/12/29 16:21:26 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：

 ChiCTR2500115630 

最近更新日期：

Date of Last Refreshed on：

 2025-12-29 16:21:10 

注册时间：

Date of Registration：

 2025-12-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价HBW-004285片新制剂在健康受试者中相对生物利用度和食物影响的I期临床试验

Public title：

Phase I Clinical Trial to Evaluate the Relative Bioavailability and Food Effect of the New Formulation of HBW-004285 Tablets in Healthy Subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价HBW-004285片新制剂在健康受试者中相对生物利用度和食物影响的I期临床试验

Scientific title：

Phase I Clinical Trial to Evaluate the Relative Bioavailability and Food Effect of the New Formulation of HBW-004285 Tablets 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：

Huang Jie 

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 8991 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, Hunan, China

Study leader's address：

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

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

Applicant's institution：

The Third Xiangya 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：

The Third Xiangya 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：

 25232

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 the Third Xiangya Hospital, Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-18 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Wang Xiaomin

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：

No. 138 Tongzipo Road, Yuelu District, Changsha, Hunan, 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临床试验中心

Primary sponsor：

Clinical Trial Center of the Third Xiangya Hospital of Central South University

研究实施负责（组长）单位地址：

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, Hunan

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)：

Country：

China

Province：

Human

City：

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：

The Third Xiangya Hospital of Central South University

Address：

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

经费或物资来源：

成都海博为药业有限公司

Source(s) of funding：

Chengdu Haibowei 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：

随机交叉对照 

Study design：

Cross-over 

研究目的：

主要目的：评价HBW-004285片不同规格制剂在健康受试者中的相对生物利用度。 次要目的：评价HBW-004285片在健康受试者中的安全性和耐受性；评价食物对HBW-004285片单次给药后药代动力学的影响。  

Objectives of Study：

Primary Objective To evaluate the relative bioavailability of HBW-004285 Tablets with different specifications in healthy subjects. Secondary Objectives To evaluate the safety and tolerability of HBW-004285 Tablets in healthy subjects. To evaluate the effect of food on the pharmacokinetics of HBW-004285 Tablets after a single 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：

1.在试验相关的任何活动开始之前，获得知情同意，并对本次试验的目的和意义有充分了解，并且愿意遵守试验方案； 2.年龄18~55岁（含边界值）； 3.男性受试者体重>=50.0 kg，女性受试者体重>=45.0 kg，体重指数（BMI）＝体重（kg）/身高^2（m^2），BMI在19.0~26.0kg/m^2范围内（含边界值）； 4.受试者能耐受高脂餐； 5.受试者在筛选前两周内未发生无保护的性行为，愿意自筛选开始至最后一次试验药物给药后3个月内无生育计划并自愿采取有效措施避孕者。

Inclusion criteria

1.Provide informed consent prior to the initiation of any trial-related activities, have a full understanding of the purpose and significance of this trial, and be willing to comply with the trial protocol; 2.Aged between 18 and 55 years old (inclusive of the boundary values); 3.For male subjects, body weight >=50.0 kg; for female subjects, body weight>=45.0 kg. Body Mass Index (BMI) is calculated as weight (kg) / height^2(m^2), with a required range of 19.0 to 26.0 kg/m^2 (inclusive of the boundary values); 4.Able to tolerate a high-fat meal; 5.Have no unprotected sexual intercourse within two weeks prior to screening; have no childbearing plans from the start of screening until 3 months after the last administration of the trial drug; and be willing to voluntarily adopt effective contraceptive measures.

排除标准：

1.既往或目前正患有循环系统、内分泌系统、神经系统、消化系统、呼吸系统、泌尿生殖系统、血液学、免疫学、精神病学及代谢异常等任何临床严重疾病者或能干扰试验结果的任何其他疾病； 2.有药物、食物或其他物质过敏史； 3.不能耐受静脉穿刺者或静脉采血困难者，有晕针晕血史者； 4.试验前 3 个月内接受过外科手术，或计划在研究期间进行外科手术者； 5.试验前14天内服用过任何药物或保健品者（包括中草药）； 6.试验前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）者； 7.试验前 3 个月内参加任何临床试验且使用了任何临床试验药物者； 8.在入选前 3 个月内献血或大量失血（>=200 mL，不包括女性月经期失血）、接受输血或使用血制品者； 9.妊娠或哺乳期妇女，以及受试者试验期间不能采用一种或一种以上的非药物避孕措施者； 10.对饮食有特殊要求，不能遵守统一饮食者，或有吞咽困难者； 11.每天饮用过量茶、咖啡和/或含咖啡因的饮料（8 杯以上，1 杯=250 mL）者； 12.研究首次用药前烟碱检查阳性者，或试验前3个月每日吸烟量多于5支者或试验期间不能停止使用任何烟草类产品者； 13.研究首次用药前酒精检测结果阳性，或试验前 6 个月内经常饮酒者，即每周饮酒超过14单位酒精（1 单位=360 mL 啤酒或 45 mL 酒精量为 40%的烈酒或 150mL 葡萄酒）或试验期间不能停止使用任何含酒精产品者； 14.研究首次用药前毒品检测阳性，或试验前3个月使用过软毒品（如：大麻）或试验前 1 年服用硬毒品（如：可卡因、苯环己哌啶等）者； 15.生命体征异常者（收缩压<90mmHg 或>=140mmHg，舒张压<50 mmHg >=90 mmHg；心率<50 bpm 或>100 bpm）或体格检查、心电图、胸片检查（正位）、腹部 B 超检查、心脏彩超、实验室检查异常有临床意义（以临床研究医生判断为准）； 16.乙型肝炎表面抗原、丙型肝炎病毒抗体、人类免疫缺陷病毒抗体和梅毒螺旋体抗体筛查阳性者； 17.有心脏疾病，包括但不限于先天性长 QT 综合征、尖端扭转型心脏病或尖端扭转型心脏病的危险因素（如心功能不全、低钾血症、长 QT 综合征家族史）、目前使用 IA 类[如奎尼丁或普鲁卡因胺]或 III 类[如胺碘酮或索他洛尔]抗心律失常药物或其他已知对 QT 间期有影响的药物，或筛选时按 Fridericia’s 标准校正的 QTc 间期（QTcF）>=450 ms(男性)，（QTcF）>=470 ms(女性)或 PR 间期＞200 ms 或 QRS 间期>=120 ms 者； 18.在首次用药前 30 天内接种过任何活疫苗者； 19.研究首次用药前48小时内，摄入过任何富含葡萄柚成份或其他影响药物吸收、分布、代谢、排泄等的饮料或食物者； 20.研究者判断疼痛测试培训不合格者（仅适用于需要进行疼痛测试的组别）； 21.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应纳入者。

Exclusion criteria：

1. Individuals who have previously or currently suffered from any clinically severe diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system\, urogenital system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that can interfere with the test results; 2. Have a history of allergies to drugs, food, or other substances; 3. Those who cannot tolerate venous puncture or have difficulty collecting blood from veins, or have a history of needle and blood fainting; 4. Those who have undergone surgery within 3 months before the trial or plan to undergo surgery during the study period; 5. Those who have taken any medication or health products (including Chinese herbal medicine) within 14 days before the experiment; 6. Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before the experiment (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 7. Those who have participated in any clinical trial and used any clinical trial drug within 3 months before the trial; 8. Those who donate blood or experience significant blood loss (>=200 mL, excluding menstrual bleeding in women), receive blood transfusions, or use blood products within the first 3 months of enrollment; 9. Pregnant or lactating women, as well as those who are unable to use one or more non pharmacological contraceptive methods during the trial period; 10. Those who have special dietary requirements and cannot follow a unified diet, or have difficulty swallowing; 11. Those who consume excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250 mL) every day; 12. Those who tested positive for nicotine before the first use of the study, or those who smoked more than 5 cigarettes per day in the three months prior to the trial, or those who were unable to stop using any tobacco products during the trial period; 13. Those who had a positive alcohol test result before the first medication use of the study, or those who frequently drank alcohol within the 6 months before the trial, that is, those who consumed more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol or 150mL of wine), or those who could not stop using any alcoholic products during the trial period; 14. Those who tested positive for drugs before the first use of the study, or had used soft drugs (such as marijuana) three months before the trial, or had taken hard drugs (such as cocaine, phencyclidine, etc.) one year before the trial; 15. Patients with abnormal vital signs (systolic blood pressure<90mmHg or>=140mmHg, diastolic blood pressure<50 mmHg>=90 mmHg; heart rate<50 bpm or>100 bpm) or abnormal physical examination, electrocardiogram, chest X-ray examination (AP), abdominal B-ultrasound examination, cardiac color ultrasound, laboratory examination have clinical significance (based on the judgment of the clinical research doctor); 16. Those who are screened positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and treponema pallidum antibody; 17. Having heart disease, including but not limited to congenital long QT syndrome, torsade de pointe, or risk factors for torsade de pointe (such as cardiac insufficiency, hypokalemia, family history of long QT syndrome), current use of Class IA [such as quinidine or procainamide] or Class III [such as amiodarone or sotalol] antiarrhythmic drugs, or other drugs known to have an impact on the QT interval, Or those with QTc interval (QTcF)>=450 ms (male), (QTcF)>=470 ms (female), PR interval>200 ms or QRS interval>=120 ms corrected according to Fridericia's standard during screening; 18. Those who have received any live vaccines within 30 days before the first medication; 19. Those who have consumed any beverage or food rich in grapefruit ingredients or other substances that affect drug absorption, distribution, metabolism, excretion, etc. within 48 hours before the first medication use in the study; 20. The researcher determines that the pain testing training is not qualified (only applicable to the group that needs to undergo pain testing); 21. The subjects may not be able to complete this study due to other reasons, or the researchers believe that they should not be included.

研究实施时间：

Study execute time：

从 From 2025-12-16 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-29 00:00:00 至 To 2026-01-31 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 5

Group：

Group A

Sample size：

干预措施：

A组受试者第一周期在空腹状态下服用2片100mg制剂，第二周期在空腹状态下服用1片200mg制剂，第三周期餐后状态下服用1片200mg制剂；

干预措施代码：

Intervention：

For subjects in Group A: In the first cycle, take 2 tablets of the 100 mg formulation under fasting conditions; In the second cycle, take 1 tablet of the 200 mg formulation under fasting conditions; In the third cycle, take 1 tablet of the 200 mg formulation under postprandial conditions.

Intervention code：

组别：

B组

样本量：

 5

Group：

Group B

Sample size：

干预措施：

B组受试者第一周期在空腹状态下服用1片200mg制剂，第二周期在餐后状态下服用1片200mg制剂，第三周期在空腹状态下服用2片100mg制剂；

干预措施代码：

Intervention：

For subjects in Group B: In the first cycle, take 1 tablet of the 200 mg formulation under fasting conditions; In the second cycle, take 1 tablet of the 200 mg formulation under postprandial conditions; In the third cycle, take 2 tablets of the 100 mg formulation under fasting conditions.

Intervention code：

组别：

C组

样本量：

 5

Group：

Group C

Sample size：

干预措施：

C组受试者第一周期在餐后状态下服用1片200mg制剂，第二周期在空腹状态下服用2片100mg制剂，第三周期在空腹状态下服用1片200mg制剂。

干预措施代码：

Intervention：

For subjects in Group C: In the first cycle, take 1 tablet of the 200 mg formulation under postprandial conditions; In the second cycle, take 2 tablets of the 100 mg formulation under fasting conditions; In the third cycle, take 1 tablet of the 200 mg formulation under fasting conditions.

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)：

 长沙 

Country：

China

Province：

Hunan

City：

Changsha

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：

药代动力学

指标类型：

主要指标

Outcome：

Pharmacokinetics

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

12-导联心电图

指标类型：

次要指标

Outcome：

Dynamic 12-lead electrocardiogram

Type：

Secondary 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：

次要指标

Outcome：

Vital Signs

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）：

受试者的随机号由独立于研究团队的随机统计师采用SAS 9.4或以上版本的PROC PLAN过程产生。

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

The randomization numbers for subjects are generated by an independent biostatistician (who is not part of the research team) using the PROC PLAN procedure in SAS 9.4 or a later version.

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：

无

Blinding：

None

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

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：

本次试验采用电子化数据管理，使用电子数据采集系统(DAS forEDC6.0或以上版本)，数据管理流程详见数据管理计划(DMP)。 DMP作为数据管理的指导性文件，由数据管理员(DM)撰写，申办方批准，数据管理工作将根据DMP定义的时间、内容及方法进行。

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

This trial adopts electronic data management, using an electronic data acquisition system (DAS forEDC version 6.0 or above), and the data management process is detailed in the Data Management Plan (DMP). As a guiding document for data management, the DMP is written by the data administrator (DM) and approved by the sponsor, and the data management work will be carried out according to the time, content and method defined by the DMP.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-12-29 16:21:10