ChiCTR2600120858 版本V1.0 版本创建时间2026/03/20 15:30:09 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：

 ChiCTR2600120858 

最近更新日期：

Date of Last Refreshed on：

 2026-03-20 15:29:40 

注册时间：

Date of Registration：

 2026-03-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

随机、开放、两序列、两周期交叉设计评价H021片的食物影响临床研究

Public title：

A random, open, two-sequence, two-period crossover design was used to evaluate the food effects of H021 tablets in a clinical study.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

随机、开放、两序列、两周期交叉设计评价H021片的食物影响临床研究

Scientific title：

A random, open, two-sequence, two-period crossover design was used to evaluate the food effects of H021 tablets in a clinical study.

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：

陈桂玲 

研究负责人：

陈桂玲 

Applicant：

Chen Guiling 

Study leader：

Chen Guiling 

申请注册联系人电话：

Applicant telephone：

 +86 18343113983

研究负责人电话：

Study leader's
telephone：

+86 571 56131317

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：

 chenguiling707@126.com

研究负责人电子邮件：

Study leader's E-mail：

 guiling.chen@shulan.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：

浙江省杭州市拱墅区东新路848号

研究负责人通讯地址：

浙江省杭州市东新路836、848号

Applicant address：

No. 836 and 848, Dongxin Road, Hangzhou, Zhejiang Province

Study leader's address：

No. 848, Dongxin Road, Gongshu District, Hangzhou

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：

树兰（杭州）医院

Applicant's institution：

Shulan (Hangzhou) Hospital

研究负责人所在单位：

树兰(杭州)医院

Affiliation of the Leader：

SHULAN(QUZHOU)HOSPITAL

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：

 J2025-151; J2025-164; 2026伦审第(2)号

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：

树兰（杭州）医院临床试验伦理委员会

Name of the ethic committee：

Clinical Trial Ethics Review Committee of Shulan (Hangzhou) Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-12 00:00:00

伦理委员会联系人：

管文花

Contact Name of the ethic committee：

Guan Wenhua

伦理委员会联系地址：

浙江省杭州市东新路836、848号

Contact Address of the ethic committee：

No. 836 and 848, Dongxin Road, Hangzhou, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 571 56131318

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 wenhua.guan@shulan.com

研究实施负责（组长）单位：

树兰（杭州）医院

Primary sponsor：

Shulan (Hangzhou) Hospital

研究实施负责（组长）单位地址：

浙江省杭州市东新路836、848号

Primary sponsor's address：

No. 836 and 848, Dongxin Road, Hangzhou, Zhejiang 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)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

树兰（杭州）医院

具体地址：

浙江省杭州市东新路836、848号

Institution
hospital：

Shulan (Hangzhou) Hospital

Address：

No. 836 and 848, Dongxin Road, Hangzhou, Zhejiang Province

经费或物资来源：

江苏柯菲平医药股份有限公司

Source(s) of funding：

Jiangsu Kefeping Pharmaceutical Co., Ltd.

研究疾病：

溃疡性结肠炎  

Target disease：

UC(ulcerative colitis)

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：

1.主要目的： (1)考察H021片（T）在中国健康成年受试者体内的药代动力学特征； (2)考察H021片（T）在中国健康成年受试者中的安全性和耐受性。 2.次要目的： (1)考察饮食（高脂餐）对中国健康成年受试者口服H021片（T）药代动力学特征、安全性和耐受性的影响。  

Objectives of Study：

1. Primary objectives: (1) To investigate the pharmacokinetic characteristics of H021 tablets (T) in healthy adult subjects in China; (2) To investigate the safety and tolerability of H021 tablets (T) in healthy adult subjects in China. 2. Secondary objectives: (1) To investigate the effects of food (high-fat meal) on the pharmacokinetic characteristics, safety, and tolerability of orally administered H021 tablets (T) in healthy adult subjects in China.

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.年龄18~55周岁（含18和55周岁）的健康成年受试者（健康是指经病史询问、体格和生命体征检查、胸部X线（正位）、实验室检查和12-导联心电图等检查结果正常或异常但经研究者判断无临床意义），男女兼有； 2.体重男性>=50.0kg，女性>=45.0kg，且体重指数（BMI）：19.0~26.0kg/m^2（含19.0和26.0，体重指数BMI=体重（kg）/身高2（m^2），保留小数点后1位）； 3.受试者自愿签署知情同意书； 4.受试者承诺自筛选至末次给予试验用药品后6个月内无生育计划、无捐精或捐卵计划，并采取适当的避孕措施，避免自己或伴侣怀孕； 5.受试者有良好的生活作息并且能够与研究者保持良好的沟通和遵守临床试验的各种要求。

Inclusion criteria

1.Healthy adult subjects aged 18 to 55 years old (inclusive of 18 and 55 years old) (health refers to normal or abnormal results of medical history inquiry, physical examination and vital signs, chest X-ray (orthopside), laboratory tests, and 12-lead electrocardiogram, etc., with the exception that the results have no clinical significance as judged by the researchers), both male and female are included. 2.Body weight for men >= 50.0 kg, for women >= 45.0 kg, and body mass index (BMI): 19.0~26.0 kg/m^2 (including 19.0 and 26.0, BMI = weight (kg) / height^2 (m^2), rounded to one decimal place); 3.The subjects voluntarily signed the informed consent form. 4.The subjects have committed to having no plans for pregnancy, sperm donation or egg donation within 6 months from the screening stage until the last administration of the test drug, and to take appropriate contraceptive measures to prevent themselves or their partners from getting pregnant. 5.The subjects had a regular lifestyle and were able to maintain good communication with the researchers as well as comply with all the requirements of the clinical trial.

排除标准：

1.有神经系统、心血管系统、血液和淋巴系统、免疫系统、肾脏、肝脏、胃肠道、呼吸系统、代谢及骨骼等系统疾病、感染性疾病、重要脏器疾病或病史，且研究者认为会影响受试者安全； 2.有临床意义的食物、药物过敏史或特应性变态反应性疾病史（如哮喘、荨麻疹、湿疹性皮炎等）或已知对试验用药品成分及辅料过敏者； 3.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； 4.存在可能显著影响药物吸收、分布、代谢和排泄的任何疾病或病史，或者可能对受试者构成危害的任何病情，如： (1)筛选时有炎症性肠病、胃溃疡、十二指肠溃疡、胃肠道/直肠出血、持久性恶心或其他具有临床意义的胃肠道异常； (2)既往有较大的胃肠道手术史（比如：胃切除术、胃肠吻合术、肠切除术、胃旁路术、胃分割术或胃囊带术、胆囊切除术，但阑尾炎手术和脱肛术除外）； (3)筛选时有肝病或具有肝功能不全的病史或证据（如AST、ALT或总胆红素＞1.5倍ULN）； (4)筛选时有肾病或具有肾功能不全的病史或证据，表现为有临床意义的肌酐异常或尿成分异常（比如蛋白尿等）； 5.筛选前3个月内饮用过量（平均一天8杯以上，1杯=250 mL）茶、咖啡或含咖啡因的饮料；或给药前48h内，摄取茶或任何含有咖啡因的食物或饮料（如咖啡、巧克力等）者； 6.筛选前3个月内平均每日吸烟超过5支；或在整个试验期间不能禁止吸烟者； 7.筛选前3个月内经常饮酒者，即平均每天饮用超过2个单位的酒精（1单位=360mL啤酒或45mL酒精量为40%的烈酒或150mL葡萄酒）；或试验期间不能禁酒者；或酒精呼气试验呈阳性者； 8.筛选前3个月内献血或失血>=400mL（女性生理性失血除外）；或接受输血或使用血制品；或计划服药期间及停药后3个月内献血者； 9.筛选前3个月内服用过毒品；或12个月内有药物滥用史/依赖史；或筛选时尿药筛查呈阳性者； 10.筛选前3个月内接种过疫苗；或试验结束后3个月内计划接种疫苗者； 11.筛选前3个月内参加过其他药物或器械临床试验且接受试验用药品或器械治疗者； 12.筛选前14天内摄入大量富含葡萄柚（即西柚）的饮料或食物（如葡萄柚、葡萄柚汁、葡萄柚果酱等）；或给药前48 h内，摄入过任何富含葡萄柚（即西柚）的饮料或食物者； 13.筛选前14天内使用过任何处方药、非处方药、中草药或保健品者； 14.病毒学检查，即乙肝表面抗原定性、丙型肝炎病毒抗体、丙型肝炎病毒核心抗原、人免疫缺陷病毒抗原抗体联合检测、梅毒螺旋体特异抗体检查，异常有临床意义者； 15.既往有结核病史；或有任何活动性结核（TB）者； 16.不能耐受静脉穿刺；或有晕针、晕血史者； 17.女性受试者正处在哺乳期或妊娠期；或血妊娠检查结果呈阳性者； 18.对饮食有特殊要求，不能接受统一饮食（包括乳糖不耐受、高脂餐不耐受等）；或有吞咽困难者； 19.受试者可能因为其他原因不能完成本研究；或研究者认为受试者存在其他不适于参与该项研究的情况。

Exclusion criteria：

1.There are diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism and bones, as well as infectious diseases, diseases of important organs or medical histories, and the researchers believe that these will affect the safety of the subjects. 2.Those with a clinically significant history of food or drug allergies, or atopic allergic diseases (such as asthma, urticaria, eczema, etc.) or those who are known to be allergic to the ingredients and excipients of the investigational drug; 3.Those who had undergone surgery within the previous 3 months, or those who plan to undergo surgery during the study period; 4. Any disease or medical history that may significantly affect drug absorption, distribution, metabolism, and excretion, or any condition that may pose a risk to the subject, such as: (1) Presence of inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal/rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities at screening; (2) History of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastric partition, gastric banding, cholecystectomy, except for appendectomy and rectal prolapse surgery); (3) Presence or history of liver disease or evidence of liver dysfunction at screening (e.g., AST, ALT, or total bilirubin >1.5 times ULN); (4) Presence or history of kidney disease or evidence of renal dysfunction at screening, manifested as clinically significant abnormal serum creatinine or urine composition abnormalities (e.g., proteinuria); 5. Consuming excessive tea, coffee, or caffeine-containing beverages within 3 months before screening (average of more than 8 cups per day, 1 cup = 250 mL); or consuming tea or any caffeine-containing food or beverage (e.g., coffee, chocolate) within 48 hours before dosing; 6. Smoking more than 5 cigarettes per day on average within 3 months before screening; or inability to refrain from smoking during the entire trial; 7. Frequent alcohol consumption within 3 months before screening, i.e., on average more than 2 units of alcohol per day (1 unit = 360 mL beer, 45 mL of 40% spirits, or 150 mL wine); or inability to abstain from alcohol during the trial; or a positive breath alcohol test; 8. Blood donation or blood loss of ≥400 mL within 3 months before screening (excluding physiological blood loss in women); or receiving transfusions or blood products; or planning to donate blood during medication and within 3 months after discontinuation; 9. Use of illicit drugs within 3 months before screening; or history of drug abuse/dependence within 12 months; or a positive urine drug screen at screening; 10. Vaccination within 3 months before screening; or planning to receive vaccinations within 3 months after the trial ends; 11. Participation in other drug or device clinical trials within 3 months before screening and receiving investigational drugs or devices; 12. Consumption of large amounts of grapefruit-containing beverages or foods (e.g., grapefruit, grapefruit juice, grapefruit jam) within 14 days before screening; or consumption of any grapefruit-containing food or beverage within 48 hours before dosing; 13. Use of any prescription drugs, over-the-counter drugs, herbal medicine, or health supplements within 14 days before screening; 14. Virological tests, including qualitative hepatitis B surface antigen, hepatitis C virus antibody, hepatitis C virus core antigen, combined detection of human immunodeficiency virus antigen and antibody, and syphilis treponemal-specific antibody tests, with abnormalities of clinical significance; 15. History of tuberculosis; or any active tuberculosis (TB); 16. Inability to tolerate venipuncture; or history of fainting at the sight of needles or blood; 17. Female subjects who are currently breastfeeding or pregnant; or positive results in blood pregnancy tests; 18. Subjects with special dietary requirements who cannot accept standardized meals (including lactose intolerance, high-fat meal intolerance, etc.); or those with difficulty swallowing; 19. Subjects who may not be able to complete this study for other reasons; or those whom the investigator considers otherwise unsuitable to participate in this study.

研究实施时间：

Study execute time：

从 From 2026-03-19 00:00:00至 To 2027-03-19 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-20 00:00:00 至 To 2027-03-18 00:00:00

干预措施：

Interventions：

组别：

餐后-空腹组

样本量：

 6

Group：

After the meal - On an empty stomach group

Sample size：

干预措施：

餐后-空腹序列组：第一周期高脂餐后口服H021片（T）12.5mg；经7天洗脱期后，第二周期空腹口服H021片（T）12.5 mg。

干预措施代码：

Intervention：

Post-meal - fasting sequence group: In the first cycle, after a high-fat meal, take H021 tablets (T) 12.5 mg orally; after a 7-day washout period, in

Intervention code：

组别：

空腹-餐后组

样本量：

 6

Group：

Before meal - After meal group

Sample size：

干预措施：

第一周期空腹口服H021片（T）12.5mg；经7天洗脱期后，第二周期高脂餐后口服H021片（T）12.5 mg

干预措施代码：

Intervention：

In the first cycle, take H021 tablets orally on an empty stomach (T) at a dose of 12.5 mg; after a 7-day washout period, in the second cycle, take H02

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 树兰（杭州）医院 

单位级别：

 三级甲等 

Institution
hospital：

Shulan (Hangzhou) Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

药代动力学参数（AUC0-∞、AUC0-t、Cmax）

指标类型：

主要指标

Outcome：

pharmacokinetics（AUC0-∞、AUC0-t、Cmax）

Type：

Primary indicator

测量时间点：

每周期给药前0.5h内以及给药后0.5h、1h至给药后144h

测量方法：

Measure time point of outcome：

Within 0.5 hours before each administration period, as well as 0.5 hours and 1 hour after administra

Measure method：

指标中文名：

临床实验室检查（血常规、血生化、尿常规、传染病）

指标类型：

次要指标

Outcome：

Clinical laboratory tests (blood routine, blood biochemistry, urine routine, infectious diseases)

Type：

Secondary indicator

测量时间点：

筛选、出组/提前退出

测量方法：

Measure time point of outcome：

Screening period, trial closure (or early withdrawal)

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：

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）：

研究开始前，将由统计单位与本项目无关的独立统计分析师应用SAS软件9.4或以上版本生成《受试者随机编码表》，作为受试者入组的依据。

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

Before the start of the study, an independent statistical analyst unrelated to this project will use SAS software version 9.4 or above to generate the "Subject Randomization Code Table", which will serve as the basis for subject enrollment.

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：

开放标签

Blinding：

Open-label study

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：

原始病历、电子统计系统

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

Original medical records, electronic statistics system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-03-20 15:29:40