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：	ChiCTR2400092217
最近更新日期： Date of Last Refreshed on：	2024-11-12 15:26:20
注册时间： Date of Registration：	2024-11-12 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	随机、双盲、安慰剂对照评价H021片单次给药在健康成年受试者中的安全性、耐受性和药代动力学/药效学（PK/PD），以及食物影响的Ia期临床研究
Public title：	Randomized, Double-Blind, Placebo-Controlled Phase Ia Clinical Study for Evaluation of the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics (PK/PD) of a Single Administration of H021 Tablets in Healthy Adult Subjects, as Well as Food Effects
注册题目简写：	H021片在健康成年受试者中的单次给药和食物影响研究
English Acronym：	Clinical Study of Single Administration and Food Effects of H021 Tablets in Healthy Adult Subjects
研究课题的正式科学名称：	随机、双盲、安慰剂对照评价H021片单次给药在健康成年受试者中的安全性、耐受性和药代动力学/药效学（PK/PD），以及食物影响的Ia期临床研究
Scientific title：	Randomized, Double-Blind, Placebo-Controlled Phase Ia Clinical Study for Evaluation of the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics (PK/PD) of a Single Administration of H021 Tablets in Healthy Adult Subjects, as Well as Food Effects
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：	姜雅琼	研究负责人：	潘杰
Applicant：	Yaqiong Jiang	Study leader：	Jie Pan
申请注册联系人电话： Applicant telephone：	+86 151 5188 0330	研究负责人电话： Study leader's telephone：	+86 153 5880 3163
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：	jiangyaqiong@carephar.com	研究负责人电子邮件： Study leader's E-mail：	pankypan@163.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：	江苏省南京市玄武区徐庄路6号	研究负责人通讯地址：	江苏省苏州市虎丘区浒墅关镇兴贤路28号
Applicant address：	6, Xuzhuang Road, Xuanwu District, Nanjing, Jiangsu	Study leader's address：	28, Xingxian Road, Xushuguan Town, Huqiu District, Suzhou, Jiangsu
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：	江苏柯菲平医药股份有限公司
Applicant's institution：	Jiangsu Carephar Pharmaceutical Co.,Ltd
研究负责人所在单位：	苏州大学附属第二医院
Affiliation of the Leader：	The Second Affiliated Hospital of Soochow 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：	JD-LS2024072-I01	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：	苏州大学附属第二医院伦理委员会
Name of the ethic committee：	The Ethics Committee of The Second Affiliated Hospital of Soochow University
伦理委员会批准日期： Date of approved by ethic committee：	2024-09-24 00:00:00
伦理委员会联系人：	华雯妍
Contact Name of the ethic committee：	Wenyan Hua
伦理委员会联系地址：	江苏省苏州市三香路1055号
Contact Address of the ethic committee：	1055, Sanxiang Road, Suzhou, Jiangsu
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 512 6778 3682	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：

苏州大学附属第二医院

Primary sponsor：

The Second Affiliated Hospital of Soochow University

研究实施负责（组长）单位地址：

江苏省苏州市虎丘区浒墅关镇兴贤路28号

Primary sponsor's address：

28, Xingxian Road, Xushuguan Town, Huqiu District, Suzhou, Jiangsu

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	江苏	市(区县)：	南京市
Country：	China	Province：	Jiangsu	City：	Nanjing
单位(医院)：	江苏柯菲平医药股份有限公司	具体地址：	徐庄路6号
Institution hospital：	Jiangsu Carephar Pharmaceutical Co., Ltd	Address：	6, Xuzhuang Road

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 Carephar Pharmaceutical Co., Ltd

研究疾病：

溃疡性结肠炎

Target disease：

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：

随机平行对照

Study design：

Parallel

研究目的：

1.研究健康成年受试者单次口服H021片的安全性和耐受性； 2.观察健康成年受试者单次口服H021片的人体PK及PD特征，为后期临床研究的剂量选择提供依据； 3.研究饮食（高脂餐）对健康成年受试者口服H021片安全性、耐受性以及对PK的影响。

Objectives of Study：

1. To study the safety and tolerability of single oral dose of H021 tablets in healthy adult subjects; 2. To observe the PK and PD characteristics in healthy adult subjects after a single oral dose of H021 tablets in order to provide a basis for dose selection in later clinical studies; 3. To study effects of diet (high-fat meal) on the safety, tolerability and PK of oral administration of H021 tablets in healthy adult 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：

Inclusion criteria

1. healthy adult subjects aged 18~55 years old (including 18 and 55 years old) of both sexes (healthy means that the results of medical history, physical and vital signs examination, chest X-ray (orthopantomogram), laboratory tests and 12-lead electrocardiogram are normal or abnormal but not clinically significant in the judgment of the investigator);
2. weight ≥50.0kg for men and ≥45.0kg for women and body mass index (BMI): 19.0~26.0kg/m2 (including 19.0 and 26.0, BMI = weight (kg)/height2 (m2), retaining 1 decimal place);
3. Subjects voluntarily signed the informed consent form;
4. subjects promise to have no birth plan, no sperm or egg donation plan, and to take appropriate contraceptive measures to avoid pregnancy by themselves or their partners from the time of signing the informed consent to 6 months after the last administration of the test drug;
5. Subjects have a good lifestyle and are able to maintain good communication with investigators and comply with 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，以及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）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者；（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、胃分割述或胃囊带术、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）筛选期尿路梗阻或尿排空困难； 4. 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者；或给药前48 h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； 5. 筛选前3个月内平均每日吸烟超过5支或者在整个试验期间不能禁止吸烟者； 6. 筛选前3个月内经常饮酒者，即平均每天超过2个单位酒精（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； 7. 筛选前3个月内献血或失血≥400mL者（女性生理性失血除外）或计划服药期间及停药后3个月内献血者； 8. 筛选前3个月内服用过毒品或12个月内有药物滥用史/依赖史者或筛选时尿药筛查呈阳性； 9. 筛选前3个月内接种过疫苗以及试验结束后3个月内计划接种疫苗者； 10. 筛选前3个月内参加过其他的药物或器械临床试验且接受试验用药品或器械治疗者； 11. 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）者；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； 12. 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； 13. 输血前八项检查，即乙肝病毒表面抗原、乙肝病毒表面抗体、乙肝病毒e抗原、乙肝病毒e抗体、乙肝病毒核心抗体、丙肝病毒IgG抗体、梅毒螺旋体特异性抗体、人类免疫缺陷病毒抗体和抗原（P24）检查，有临床意义者； 14. 不能耐受静脉穿刺者，或有晕针、晕血史者； 15. 女性受试者正处在哺乳期或妊娠期，或妊娠检查阳性者； 16. 对饮食有特殊要求，不能接受统一饮食者（包括乳糖不耐受者，以及食物影响研究中不能耐受高脂饮食者）；或有吞咽困难者； 17. 研究者认为的其他不适于参与该项研究的情况

Exclusion criteria：

1. Subjects have a history of neurological, cardiovascular, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, skeletal or other systemic diseases, infectious diseases, or diseases of vital organs that, in the opinion of the investigator, would compromise the safety of subjects; 2. Subjects have a history of clinically significant food or drug allergies or a history of atopic allergic disease (e.g., asthma, urticaria, eczematous dermatitis, etc.) or a known hypersensitivity to the components and excipients of the test drug; 3. Subjects who have undergone surgery within 3 months prior to screening or plan to undergo surgery during the study period,or have any disease or history of disease that may significantly affect the absorption, distribution, metabolism, and excretion of the drug, or any condition that may pose a hazard to the subject, such as: (1)Subjects with inflammatory bowel disease, gastric ulcers, duodenal ulcers, gastrointestinal/rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities; (2) Subjects have a prior history of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastric division described or gastric pouch banding, cholecystectomy, with the exception of appendicitis surgery and prolapse); (3)Subjects have liver disease or have a history or evidence of hepatic insufficiency (e.g., AST, ALT, or total bilirubin > 1.5 times ULN) at screening; (4) Subjects have renal disease or have a history or evidence of renal insufficiency at screening, as evidenced by clinically significant creatinine abnormalities or abnormal urine composition (e.g., proteinuria, etc.); (5) Subjects have urinary tract obstruction or difficulty emptying urine at screening; 4. Subjects who have consumed excessive amounts (more than 8 cups a day on average, 1 cup = 250 mL) of tea, coffee, or caffeinated beverages in the 3 months prior to screening; or who have ingested tea or any caffeine-containing foods or beverages (e.g., coffee, chocolate, etc.) in the 48 h prior to dosing; 5. Subjects smoked more than 5 cigarettes per day on average in the 3 months prior to screening or were unable to stop smoking for the entire duration of the trial; 6. Subjects have consumed alcohol on a regular basis during the 3 months prior to screening, i.e., an average of more than 2 units of alcohol per day (1 unit = 360mL of beer or 45mL of 40% alcohol by volume spirits or 150mL of wine) or are unable to stop consuming alcohol during the test period; or have a positive breath test result for alcohol; 7. Subjects have donated blood or lost blood≥400mL (except for physiologic blood loss in women) within 3 months prior to screening, or plan to donate blood during the period of medication administration through 3 months after discontinuation of medication; 8. Subjects who have taken drugs within 3 months or have a history of substance abuse/dependence within 12 months prior to screening or have a positive urine drug screen at screening; 9. Subjects who have been vaccinated within 3 months prior to screening and those who plan to be vaccinated within 3 months of the end of the trial; 10. Subjects have participated in a clinical trial of another drug or device within 3 months prior to screening and has been treated with the trial drug or device; 11. Subjects have ingested a significant amount of grapefruit (i.e., grapefruit)-rich beverages or foods (e.g., grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days prior to screening; or have ingested any grapefruit (i.e., grapefruit) rich beverage or food within 48 h prior to dosing; 12. Subjects who have used any prescription, over-the-counter, herbal, or nutraceutical medications within 14 days prior to screening; 13. Subjects have a clinically significant pre-transfusion octet of tests, that is, Hepatitis B Virus Surface Antigen, Hepatitis B Virus Surface Antibody, Hepatitis B Virus e Antigen, Hepatitis B Virus e Antibody, Hepatitis B Virus Core Antibody, Hepatitis C Virus IgG Antibody, Treponema pallidum Specific Antibody, and Human Immunodeficiency Virus Antibody and Antigen (P24) tests; 14. Subjects are unable to tolerate venipuncture or have a history of needle or blood sickness; 15. Female subjects are lactating or pregnant, or have a positive pregnancy test result; 16. Subjects have special dietary requirements and are unable to accept a uniform diet (including lactose intolerant individuals and those who cannot tolerate a high-fat diet in the food effect study); or have difficulty swallowing; 17. Subjects who, in the opinion of the Investigator, are otherwise unfit to participate in the study.

研究实施时间：

Study execute time：

从 From 2024-11-01 00:00:00至 To 2025-11-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-11-15 00:00:00 至 To 2025-10-15 00:00:00

干预措施：

Interventions：

组别：	6.25mg剂量组	样本量：	8
Group：	6.25 mg dosage group	Sample size：	8
干预措施：	空腹单次口服6.25mg（1/4片）H021片	干预措施代码：
Intervention：	Single oral dose of 6.25 mg (1/4 tablet) H021 tablet in the fasting state.	Intervention code：

组别：	12.5mg剂量组	样本量：	10
Group：	12.5 mg dosage group	Sample size：	10
干预措施：	8例受试者空腹单次口服12.5mg（1/2片）H021片；2例受试者空腹单次口服12.5mg（1/2片）H021片安慰剂	干预措施代码：
Intervention：	8 subjects received a single oral dose of 12.5 mg (1/2 tablet) of H021 tablet, and 2 subjects received a single oral dose of 12.5 mg (1/2 tablet) of placebo in the fasting state.	Intervention code：

组别：	25mg剂量组	样本量：	10
Group：	25 mg dosage group	Sample size：	10
干预措施：	8例受试者空腹单次口服25mg（1/2片）H021片；2例受试者空腹单次口服25mg（1/2片）H021片安慰剂	干预措施代码：
Intervention：	8 subjects received a single oral dose of 25 mg (1 tablet) of H021 tablet, and 2 subjects received a single oral dose of 25 mg (1 tablet) of placebo in the fasting state.	Intervention code：

组别：	50mg剂量组	样本量：	10
Group：	50 mg dosage group	Sample size：	10
干预措施：	8例受试者空腹单次口服50mg（2片）H021片；2例受试者空腹单次口服50mg（2片）H021片安慰剂	干预措施代码：
Intervention：	8 subjects received a single oral dose of 50 mg (2 tablets) of H021 tablets, and 2 subjects received a single oral dose of 50 mg (2 tablets) of placebo in the fasting state.	Intervention code：

组别：	100mg剂量组	样本量：	10
Group：	100 mg dosage group	Sample size：	10
干预措施：	8例受试者空腹单次口服100mg（4片）H021片；2例受试者空腹单次口服100mg（4片）H021片安慰剂	干预措施代码：
Intervention：	8 subjects received a single oral dose of 100 mg (4 tablets) of H021 tablets, and 2 subjects received a single oral dose of 100 mg (4 tablets) of placebo in the fasting state.	Intervention code：

组别：	空腹-餐后组	样本量：	7
Group：	Fasting-postprandial group	Sample size：	7
干预措施：	第1周期空腹单次口服25mg（1片）H021片，第2周期餐后单次口服25mg（1片）H021片	干预措施代码：
Intervention：	Subjects received a single oral dose of 25 mg (1 tablet) H021 tablet in the fasting and postprandial state in the two cycles separately.	Intervention code：

组别：	餐后-空腹组	样本量：	7
Group：	Postprandial-fasting group	Sample size：	7
干预措施：	第1周期餐后单次口服25mg（1片）H021片，第2周期空腹单次口服25mg（1片）H021片	干预措施代码：
Intervention：	Subjects received a single oral dose of 25 mg (1 tablet) H021 tablet in the postprandial and fasting state in the two cycles separately.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏省	市(区县)：	南京市
Country：	China	Province：	Jiangsu	City：	Nanjing
单位(医院)：	苏州大学附属第二医院	单位级别：	三甲
Institution hospital：	The Second Affiliated Hospital of Soochow University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	单次给药研究：安全性指标	指标类型：	主要指标
Outcome：	Single-dose study: safety 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：	单次给药研究：PK参数	指标类型：	次要指标
Outcome：	Single-dose study:PK parameters	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	单次给药研究：PD参数	指标类型：	次要指标
Outcome：	Single-dose study:PD parameters	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	食物影响研究：PK参数	指标类型：	主要指标
Outcome：	Food effect study: 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：	食物影响研究：安全性指标	指标类型：	次要指标
Outcome：	Food effect study: safety indicators	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：	全血	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（仅50mg剂量组）	组织：
Sample Name：	Urine (50 mg dosage group only)	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：	粪便（仅50mg剂量组）	组织：
Sample Name：	Manure (50 mg dosage group only)	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）：

在本研究筛选期间，将为签署知情同意书并接受筛选的受试者分配一个筛选号。在确认受试者的合格性后，受试者根据筛选号从小到大的顺序分配受试者相应的随机号。

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

During the screening period, a screening number will be assigned to subjects who have signed the informed consent form and have been screened. Subjects will be assigned the corresponding randomization number according to the sequence of the screening number after confirming the eligibility.

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：	单次给药研究：双盲（6.25mg剂量组除外）食物影响研究：开放标签
Blinding：	Single-dose study: double-blind (except 6.25 mg dosage group) Food effect study: open label

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：	数据采集和管理由两部分组成：一为病例记录表，二为电子采集系统.
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection and management consists of two parts: case record form (CRF) and electronic data capture (EDC) system.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2024-11-12 15:26:13