简体中文|English
Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

To evaluate the safety and tolerability of TAN-118 tablets in healthy adult subjects

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注册号：

Registration number：

ChiCTR2500102120 

最近更新日期：

Date of Last Refreshed on：

2025-05-08 17:46:25 

注册时间：

Date of Registration：

2025-05-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价TAN-118片在成人健康受试者中的安全性、耐受性研究

Public title：

To evaluate the safety and tolerability of TAN-118 tablets in healthy adult subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价TAN-118片在成人健康受试者中的单、多次给药的安全性、耐受性、药代动力学和食物影响的I期临床试验

Scientific title：

Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and food effect of single and multiple doses of TAN-118 tablets in healthy adult 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：

贾剑敏 

研究负责人：

樊宏伟 

Applicant：

Jianmin Jia 

Study leader：

Hongwei Fang 

申请注册联系人电话：

Applicant telephone：

+86 130 6269 9498

研究负责人电话：

Study leader's telephone：

+86 25 5288 7030

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：

clinical_trial@thederma.com

研究负责人电子邮件：

Study leader's E-mail：

fanhongwei178@sina.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：

上海市浦东新区祖冲之路865号

研究负责人通讯地址：

江苏省南京市雨花区共青团路32号

Applicant address：

865 Zuchongzhi Road, Pudong New Area, Shanghai

Study leader's address：

No. 32, Communist Youth League Road, Yuhua District, Nanjing City, Jiangsu 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：

上海泽德曼医药科技有限公司

Applicant's institution：

Shanghai Thederma Pharmaceutical Technology Co., Ltd

研究负责人所在单位：

南京市第一医院

Affiliation of the Leader：

Nanjing First Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

YW20250327-02

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：

南京市第一医院伦理委员会

Name of the ethic committee：

Ethics Committee of Nanjing First Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-03-27 00:00:00

伦理委员会联系人：

周洁

Contact Name of the ethic committee：

Jie Zhou

伦理委员会联系地址：

中国江苏省南京市秦淮区长乐路68号

Contact Address of the ethic committee：

No. 68, Changle Road, Qinhuai District, Nanjing City, Jiangsu Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 25 5227 1064

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：

南京市第一医院

Primary sponsor：

Nanjing First Hospital

研究实施负责（组长）单位地址：

江苏省南京市雨花区共青团路32号

Primary sponsor's address：

No. 32, Communist Youth League Road, Yuhua District, Nanjing City, Jiangsu 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)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海泽德曼医药科技有限公司

具体地址：

上海市浦东新区祖冲之路865号

Institution
hospital：

Shanghai Thederma Pharmaceutical Technology Co., Ltd

Address：

865 Zuchongzhi Road, Pudong New Area, Shanghai

经费或物资来源：

上海泽德曼医药科技有限公司

Source(s) of funding：

Shanghai Thederma Pharmaceutical Technology Co., Ltd

Target disease：

InflammatoryBowelDisease,IBD

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：

评价成人健康受试者单次、多次口服TAN-118片的安全性、耐受性、药代动力学和食物影响  

Objectives of Study：

To evaluate the safety, tolerability, pharmacokinetics and food effect of single and multiple oral doses of TAN-118 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：

1.受试者须自愿参加本研究，书面签署知情同意书，并能够完成所有研究相关程序和访视； 2.筛选时，年龄18-45岁（含临界值），男女不限； 3.身体质量指数（Body Mass Index, BMI）为18.0-26.0 kg/m2（含临界值）；男性受试者体重≥50 kg，女性受试者体重≥45 kg； 4.女性受试者须满足以下至少一个条件 ： a. 具有生育潜能的女性（Women of Childbearing Potential, WOCBP）须在筛选时和首次给药前经血清妊娠试验确认结果为阴性，并在整个研究期间以及给药后至少3个月内同意采取有效的避孕措施； b. 绝经前女性满足其中一个条件的： i. 绝经前女性接受过子宫切除术，且有病历记录； ii. 绝经前女性接受过双侧输卵管切除术，且有病历记录； iii. 绝经前女性接受过双侧卵巢切除术，且有病历记录； iv. 首选或日常生活禁欲的受试者 c. 绝经后女性（在没有其他生物学或生理原因的情况下，停经12个月或以上）。 5.男性受试者须满足以下至少一个条件： a. 与WOCBP有性行为的男性须同意在整个研究期间以及给药后至少3个月内同意采取有效的避孕措施。此外，男性受试者在此期间无捐精计划； b. 接受过输精管切除术的男性可免于避孕要求。 研究者应当向WOCBP受试者和与WOCBP有性行为的男性受试者强调避孕的重要性以及非预期怀孕可能存在的影响。

Inclusion criteria

1. Participants must voluntarily join this study, sign the informed consent form in person, and be capable of completing all study-related procedures and visits. 2. At the time of screening, participants must be aged 18 to 45 years (inclusive), with no gender restrictions. 3. Body Mass Index (BMI) should be between 18.0 and 26.0 kg/m^2 (inclusive); male participants' weight should be >= 50 kg, and female participants' weight should be >= 45 kg. 4. Female subjects must meet at least one of the following conditions: a. Women of Childbearing Potential (WOCBP) must have negative results confirmed by serum pregnancy tests at the time of screening and before the first administration, and agree to take effective contraceptive measures throughout the study period and for at least 3 months after administration; b. Premenopausal women who meet one of these conditions: i. Premenopausal women who have undergone hysterectomy and have medical records; ii. Premenopausal women who have undergone bilateral salpingectomy and have medical records; iii. Premenopausal women who have undergone bilateral oophorectomy and have medical records; iv. Preferred or daily abstinent subjects c. Postmenopausal women (who have been absent for 12 months or more without other biological or physiological reasons). 5. Male subjects must meet at least one of the following conditions: a. Men who have had sexual intercourse with WOCBP must agree to take effective contraceptive measures throughout the study period and for at least 3 months after administration. Furthermore, male subjects had no sperm donation plans during this period. b. Men who have undergone vasectomy are exempt from contraceptive requirements. Researchers should emphasize the importance of contraception and the possible effects of unintended pregnancies to WOCBP subjects and male subjects who have sexual activity with WOCBP.

排除标准：

1.对任何药物和/或食物有过敏史或过敏体质者； 2.有运动系统、神经系统、精神系统、内分泌系统、血液循环系统、呼吸系统、消化系统、泌尿系统、生殖系统、免疫系统异常等病史，或现有上述疾病，经研究者判断影响目前研究评估者； 3.筛选期生命体征、体格检查、血常规、血生化、凝血功能、尿常规、12导联心电图、超声波检查等检查异常且经研究者判定具有临床意义者； 4.曾有用药后肝毒性反应史； 5.现患有或既往患有（本研究首次给药前3个月内）任何可能影响药物药代动力学的胃肠道疾病（如胃、胆囊切除术史）者（阑尾切除术除外）； 6.首次给药前4周内接受过重大外科手术者； 7.既往患有或现患有恶性肿瘤者； 8.存在有病历记录的先天性长QT综合征，和/或筛选或首次入院检查时校正的QT间期（Fridericia公式）男性＞450 ms，女性＞460ms 9.首次给药前2个月内献血或失血超过100 mL，或首次给药前10个月内献血或失血超过1.5 L（男性受试者）/ 1.0 L（女性受试者）（女性生理期除外） 10.无法耐受静脉穿刺和/或采血困难者； 11.对饮食有特殊要求，不能遵守统一饮食或有吞咽困难者； 12.筛选前3个月内每日吸烟量≥3支者；入院检查时，烟检测试结果为阳性者； 13.筛选前5年内有滥用药物或毒品成瘾史；筛选或入院检查时，药物筛查试验（吗啡、甲基安非他明、氯胺酮、四氢大麻酚酸、可卡因、二亚甲基双氧安非他明）结果为阳性； 14.筛选前3个月内每周饮酒超过24单位酒精（1单位≈250 mL啤酒或100 mL葡萄酒或35 mL烈酒）者；试验期间不能禁酒者；入院检查时，酒精呼气检测结果＞0 mg/100 mL者； 15.首次给药前72h内摄入含咖啡因或者黄嘌呤的食物或者饮品者； 16.首次给药前14天内至试验结束摄入已知可调节CYP酶活性的食物/膳食补充剂（如食用火龙果、芒果、西柚/葡萄柚、杨桃、血橙和/或由其制备的食品或饮品）； 17.乳糖不耐受者（曾发生过喝牛奶腹泻者）； 18.筛选时传染病筛查阳性检测结果，包括乙型肝炎表面抗原（HBsAg）、丙型肝炎（HCV）抗体、人类免疫缺陷病毒（HIV）抗体、梅毒螺旋体抗体（TPAb）； 19.在首次给药前28天内使用了任何处方药、非处方药、任何维生素药品或保健品、草药，研究者知悉并允许的用药除外； 20.筛选前3个月内患有任何严重的急性或慢性细菌、病毒或真菌感染（如肺炎、败血症）； 21.首次给药前2个月内患有活动性疱疹病毒感染（如1型单纯疱疹病毒、2型单纯疱疹病毒和带状疱疹病毒），首次给药前7天内出现其他活动性感染或发热性疾病； 22.首次给药前2个月内接种过活疫苗或减毒活疫苗者； 23.妊娠期或哺乳期女性，血妊娠试验阳性者； 24.既往接受过本研究药物者； 25.筛选前3个月内入组其他临床试验或正在参加其他临床试验者（如果受试者在接受试验治疗前退出试验，即未被随机化，或虽随机而未接受试验治疗，则可以参加本研究）； 26.经研究者判断，受试者存在其他不宜参加此研究的因素。

Exclusion criteria：

1. Those with a history of allergy to any drugs and/or foods or with an allergic constitution; 2. Those with a history of or currently suffering from abnormalities in the musculoskeletal system, nervous system, mental system, endocrine system, circulatory system, respiratory system, digestive system, urinary system, reproductive system, or immune system, and judged by the researcher to affect the current study assessment; 3. Those with abnormal results in vital signs, physical examination, blood routine, blood biochemistry, coagulation function, urine routine, 12-lead electrocardiogram, and ultrasound examination during the screening period and judged by the researcher to have clinical significance; 4. There is a history of hepatotoxic reactions after medication. 5. Those with a history of or currently suffering from any gastrointestinal diseases that may affect drug pharmacokinetics (such as history of gastrectomy or cholecystectomy) (except appendectomy); 6. Those who have undergone major surgery within 4 weeks before the first dose; 7. Those with a history of or currently suffering from malignant tumors; 8. Those with a documented history of congenital long QT syndrome, and/or a corrected QT interval (Fridericia formula) of >450 ms for men and >460 ms for women at screening or the first hospitalization examination; 9. Those who have donated blood or lost more than 100 mL of blood within 2 months before the first dose, or donated blood or lost more than 1.5 L (for male subjects) / 1.0 L (for female subjects) within 10 months before the first dose (except during the female menstrual period); 10. Those who cannot tolerate venipuncture and/or have difficulty in blood collection; 11. Those with special dietary requirements and unable to follow a unified diet or have difficulty in swallowing; 12. Those who have smoked >= 3 cigarettes per day within 3 months before screening; those with a positive result in the smoke test at the time of hospitalization examination; 13. Those with a history of drug or drug abuse within 5 years before screening; those with positive results in the drug screening test (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid, cocaine, 3,4-methylenedioxymethamphetamine) at screening or the time of hospitalization examination; 14. Those who have consumed more than 24 units of alcohol per week within 3 months before screening; those who cannot abstain from alcohol during the trial; those with a positive result in the alcohol breath test at the time of hospitalization examination (>0 mg/100 mL); 15. Those who consume food or beverages containing caffeine or xanthine within 72 hours before the first administration; 16. Within 14 days before the first administration until the end of the trial, consume known foods/dietary supplements that can regulate CYP enzyme activity (such as eating pitaya, mango, grapefruit/grapefruit, star fruit, blood orange and/or foods or beverages prepared from them); 17. People with lactose intolerance (those who have experienced diarrhea after drinking milk); 18. Positive test results of infectious disease screening during screening, including hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody (TPAb); 19. Any prescription drugs, over-the-counter drugs, any vitamin medicines or health supplements, herbs were used within 28 days prior to the first administration, except for the medications known and permitted by the researcher; 20. Have suffered from any severe acute or chronic bacterial, viral or fungal infections (such as pneumonia, sepsis) within 3 months prior to screening; 21. Having active herpes virus infections (such as herpes simplex virus type 1, herpes simplex virus type 2 and herpes zoster virus) within 2 months before the first administration, and having other active infections or febrile diseases within 7 days before the first administration; 22. Those who have received live vaccines or attenuated live vaccines within 2 months prior to the first administration; 23. Pregnant or lactating women with a positive blood pregnancy test; 24. Those who have previously received the drugs in this study; 25. Those who were enrolled in other clinical trials or are currently participating in other clinical trials within 3 months before screening (if the subjects withdrew from the trial before receiving the trial treatment, that is, they were not randomized, or although randomized, they did not receive the trial treatment, they can participate in this study); 26. Those judged by the researcher to have other factors that make them unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2025-03-28 00:00:00至 To 2027-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-05-16 00:00:00 至 To 2026-05-26 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

72

Group：

Experimental group

Sample size：

干预措施：

TAN-118片

干预措施代码：

Intervention：

TAN-118 Tablets

Intervention code：

组别：

对照组

样本量：

20

Group：

Control group

Sample size：

干预措施：

安慰剂

干预措施代码：

Intervention：

Placebo

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

  

Country：

China 

Province：

Jiangsu 

City：

 

单位(医院)：

南京市第一医院 

单位级别：

三甲 

Institution
hospital：

Nanjing First Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

生命体征（血压、呼吸、脉搏和额温）、体格检查、实验室检查、心电图检查等较基线的异常改变，不良事件、严重不良事件及发生率，最大耐受剂量（MTD）

指标类型：

主要指标

Outcome：

Abnormal changes from baseline in vital signs (blood pressure, respiratory rate, pulse rate and forehead temperature), physical examination, laboratory tests, electrocardiogram (ECG) tests, etc., adverse events, serious adverse events and their incidence rates, maximum tolerated dose (MTD)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PK参数和PD参数

指标类型：

次要指标

Outcome：

PK parameters and PD parameters

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 45 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）：

本试验采用区组随机化方法，由统计单位采用SAS（9.4或更高版本）软件生成随机号及其对应的组别（试验药物或安慰剂；空腹-高脂饮食或高脂饮食-空腹）。

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

This trial employed block randomization. The statistical unit generated random numbers and their corresponding groups (experimental drug or placebo; fasting-high-fat diet or high-fat diet-fasting) using SAS (version 9.4 or higher) software.

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（研究者和受试者）

Blinding：

Double blinded (researchers and participants)

是否共享原始数据：

IPD sharing

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：

CRF, EDC

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

CRF, EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-05-08 17:46:21
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