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：	ChiCTR2600120509
最近更新日期： Date of Last Refreshed on：	2026-03-16 14:35:54
注册时间： Date of Registration：	2026-03-16 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局部药代动力学的I期临床试验
Public title：	Phase I clinical trial to evaluate the local pharmacokinetics 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、多次给药的局部药代动力学的I期临床试验
Scientific title：	Phase I clinical trial to evaluate the local pharmacokinetics 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 Fan
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
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	YW20260108-03	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：	2026-01-08 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

研究疾病：

炎症性肠病

Target disease：

InflammatoryBowelDisease,IBD

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：

单臂

Study design：

Single arm

研究目的：

定量分析单次与多次给药后TAN-118及其主要代谢物在不同结肠段组织中的浓度分布。

Objectives of Study：

Quantitative analysis of the concentration distribution of TAN-118 and its main metabolites in different colon segments after single and multiple dosing.

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

排除标准：

1.严重或活动性下消化道疾病及结肠镜禁忌证： · 己知或疑似胃肠穿孔、肠壁完整性受损； · 中毒性巨结肠、急性重症结肠炎/暴发性溃病性结肠炎、急性憩室炎； · 严重未控制的腹膜炎或败血症； · 严重活动性下消化道疾病，如活动性肠道出血、近期( ≤3 个月)下消化道显著出血史、重度痔源性出血等，经研究者判断不适合行结肠镜及冷圈套息肉切除术者； 2.炎症性肠病及其他重要胃肠疾病史 · 既往诊断为炎症性肠病(溃疡性结肠炎、克罗恩病等) ; · 受试者本人或一级亲属有炎症性肠病病史，经研究者判断提示其为高危人群者; · 任何可能明显影响研究药物吸收、药代动力学或增加结肠镜并发症风险的胃肠疾病(阑尾切除除外) . 包括但不限于大范围肠切除、短肠综合证、严重慢性腹泻等。 3.出血风险相关疾病及用药 · 既往或家族性出血性疾病(如血友病、血小板功能障碍、遗传性出血性毛细血管扩张症等) ; · 疑血功能或血小板计数明显异常，或经研究者判断存在临床意义的出血/血栓风险者； · 需持续使用抗血小板药物或抗凝药物，且无法按照结肠镜及高出血风险内镜操作相关指南要求，在操作前适当停药或调整管理者。 4.麻醉与全身状况不佳 · ASA分级主III 级，或麻醉评估认为不宜接受镇静/麻醉及结肠镜操作者； · 心、肺、肝、肾等重要脏器功能不全，或任何经研究者判断具有临床意义、增加镇静/麻醉或结肠镜风险的系统性疾病； · 既往或现患恶性肿瘤者(非黑色素瘤皮肤癌且已治愈≥5年者可由研究者酌情判断是否纳入) ; · 既往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经Fridericia公式校正的QT间期(QTcF) >450 ms，或存在其他具有临床意义的心律失常。 5.既往腹部手术及解剖结构异常 · 既往行结直肠切除术或其他导致结肠解剖结构明显改变、可能影响结肠镜操作安全性或组织取样可行性的腹部大手术者； · 其他腹部手术史经研究者判断增加结肠镜穿孔、出血或操作困难风险者。 6.近期大手术或大量失血 · 首次给药前4 周内接受过重大外科手术者； · 首次给药前2个月内献血或失血总量超过100 mL，或首次给药前10个月内献血或失血总量超过1.5 L 者。 7.肝功能、肾功能及其他实验室异常 · 筛选期肝功能、肾功能、电解质、血常规、生化、凝血功能、尿常规等检查存在具有临床意义的异常，经研究者认为不适宜参加本研究者； · 既往有用药后肝毒性反应史，或既往被诊断为药物性肝损伤（DILI）者。 8.感染性疾病及疫苗接种 · 筛选时传染病筛查阳性结果，包括乙型肝炎表面抗原（HBsAg) 、丙型肝炎病毒抗体( HCV Ab ) 、人类免疫缺陷病毒抗体( HIV Ab ) 、梅毒螺旋体抗体（TPAb ) ; · 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、败血症等) ; · 首次给药前2个月内患有活动性疱疹病毒感染(如1型/2 型单纯疱疹病毒、带状疱疹病毒) ，或首次给药前7 天内出I见其他活动性感染或发热性疾病； · 首次给药前2个月内接种过活疫苗或减毒活疫苗者。 9.药物、食物及过敏相关因素 · 对研究药物或其任何辅料，以及本研究中使用的肠道准备药物、镇静/麻醉药物或常用急救药物有明确严重过敏史者； · 有严重药物过敏体质，或对多种药物和/或食物存在广泛过敏，经研究者判断不适宜参加本研究者； · 在首次给药前28 天内使用任何可能影响研究药物药代动力学或安全性评价的处方药、非处方药、维生素、保健品或草药(经研究者知悉并判断不会影响本研究者除外) ; · 首次给药前2个月内至试验结束期间摄入已知可显著调节CYP酶活性的食物/膳食补充剂(如西柚/葡萄柚、血橙、杨桃等)且无法遵守方案要求避免者。 10.吸烟、酒精及药物滥用 . 筛选前3个月内每日吸烟量≥3 支或使用相当量尼古丁制品，且不愿或不能在试验期间接方案要求控制或停止使用者; · 筛选前5年内有药物滥用或毒品成瘾史者； · 入院时药物滥用筛查( 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)结果为阳性者； · 筛选前3个月内每周饮酒超过24 单位酒精，或试验期间不能禁酒者，或入院时酒精呼气检测结果>0mg/ l00mL者。 11.饮食及结肠镜准备依从性不足 · 对饮食有特殊要求或存在吞咽因难，不能遵守统一饮食、清淡低纤维/低残留饮食及肠道准备要求者； · 无法耐受肠镜准备(包括服用泻剂)或结肠镜操作，或静脉穿刺困难、无法完成本研究所需多次采血/静脉通路建立者。 12.与其他研究冲突 · 既往接受过本研究药物者； · 筛选前3 个月内参加过其他干预性临床试验或正在参加其他临床试验者( 如受试者在其他试验中未接受试验治疗或虽被随机分组但未实际接受试验治疗，经研究者判断对本研究无影响者，可酌情纳入)。 13.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. Severe or active lower gastrointestinal diseases and contraindications for colonoscopy: - Known or suspected gastrointestinal perforation, intestinal wall integrity impairment; - Toxic megacolon, acute severe colitis / fulminant ulcerative colitis, acute diverticulitis; - Severe uncontrolled peritonitis or sepsis; - Severe active lower gastrointestinal diseases, such as active intestinal bleeding, significant lower gastrointestinal bleeding history within the recent period (<=3 months), severe hemorrhoids bleeding, etc., judged by the investigator as unsuitable for colonoscopy and cold snare polypectomy. 2. History of inflammatory bowel disease and other significant gastrointestinal diseases - Previously diagnosed inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.); - The subject or their first-degree relatives have a history of inflammatory bowel disease, and the investigator judges them to be at high risk; - Any gastrointestinal diseases that may significantly affect the absorption of the study drug, pharmacokinetics, or increase the risk of colonoscopy complications (except appendectomy). Including but not limited to extensive intestinal resection, short bowel syndrome, severe chronic diarrhea, etc. 3. Diseases and medications related to bleeding risk - Previous or familial bleeding disorders (such as hemophilia, platelet dysfunction, hereditary hemorrhagic telangiectasia, etc.); - Suspected abnormal blood function or platelet count, or the investigator judges there is a clinically significant bleeding/thrombosis risk; - Need to continuously use antiplatelet drugs or anticoagulants, and cannot appropriately discontinue or adjust the medication as required by the guidelines for colonoscopy and high-risk endoscopic procedures. 4. Poor anesthesia and general condition - ASA grade III or above, or the anesthesiologist assesses that the subject is not suitable for sedation/anesthesia and colonoscopy; - Incomplete function of important organs such as the heart, lungs, liver, and kidneys, or any systemic diseases judged by the investigator to have clinical significance and increase the risk of sedation/anesthesia or colonoscopy; - Previous or current history of malignant tumors (non-melanoma skin cancer that has been cured for >=5 years can be judged by the investigator whether to include); - Previous medical records of congenital long QT syndrome, and/or a corrected QT interval (QTcF) > 450 ms at screening or the first hospitalization check, or other clinically significant arrhythmias. 5. Previous abdominal surgery and abnormal anatomical structures - Previous colorectal resection or other major abdominal surgeries that cause significant changes in the anatomy of the colon and may affect the safety of colonoscopy or the feasibility of tissue sampling; - Other abdominal surgery history judged by the investigator to increase the risk of colonoscopy perforation, bleeding, or difficulty in operation. 6. Recent major surgery or significant blood loss - Major surgery within 4 weeks before the first dose; - Blood donation or blood loss of more than 100 mL within 2 months before the first dose, or blood donation or blood loss of more than 1.5 L within 10 months before the first dose. 7. Abnormal liver function, kidney function, and other laboratory tests - Abnormal liver function, kidney function, electrolytes, blood routine, biochemistry, coagulation function, urine routine, etc. during the screening period, judged by the investigator as unsuitable for this study; - Previous history of drug-induced liver toxicity or previously diagnosed drug-induced liver injury (DILI). 8. Infectious diseases and vaccination - Positive results of infectious disease screening at screening, including hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), Treponema pallidum antibody (TPAb). · Exclusion criteria for any severe acute or chronic bacterial, viral or fungal infections (such as pneumonia, sepsis, etc.) within 3 months prior to screening; · Active herpesvirus infection (such as herpes simplex virus type 1/2, varicella-zoster virus) within 2 months prior to the first dose, or other active infections or febrile diseases within 7 days prior to the first dose; · Receipt of live or attenuated live vaccines within 2 months prior to the first dose. 9. Drug, food and allergy-related factors · A clear history of severe allergy to the study drug or any of its excipients, as well as the bowel preparation drugs, sedative/anesthetic drugs or commonly used emergency drugs used in this study; · A severe drug allergy constitution or extensive allergies to multiple drugs and/or foods, and judged by the investigator as unsuitable for participation in this study; · Use of any prescription drugs, over-the-counter drugs, vitamins, health supplements or herbal medicines that may affect the pharmacokinetics or safety evaluation of the study drug within 28 days prior to the first dose (except those known to the investigator and judged not to affect this study); · Intake of foods/dietary supplements known to significantly regulate CYP enzyme activity (such as grapefruit, blood orange, star fruit, etc.) within 2 months prior to the first dose to the end of the trial and unable to comply with the protocol requirements to avoid them. 10. Smoking, alcohol and drug abuse · Daily smoking of ≥3 cigarettes or use of equivalent nicotine products within 3 months prior to screening, and unwilling or unable to control or stop as required by the protocol during the trial; · History of drug abuse or drug addiction within 5 years prior to screening; · Positive results of drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinolic acid, cocaine, 3,4-methylenedioxymethamphetamine) at admission; · Consumption of more than 24 units of alcohol per week within 3 months prior to screening, or inability to abstain from alcohol during the trial, or breath alcohol test result >0mg/100mL at admission. 11. Inadequate compliance with diet and colonoscopy preparation · Special dietary requirements or swallowing difficulties, unable to comply with the unified diet, low-fiber/low-residue diet and bowel preparation requirements; · Inability to tolerate bowel preparation (including taking laxatives) or colonoscopy procedures, or difficulty with venipuncture and inability to complete multiple blood draws/venous access establishment required for this study. 12. Conflicts with other studies · Previous exposure to the study drug; · Participation in other interventional clinical trials or ongoing participation in other clinical trials within 3 months prior to screening (if the subject did not receive the trial treatment in other trials or was randomly assigned but did not actually receive the trial treatment, and the investigator judges that it has no impact on this study, it may be considered for inclusion at the discretion of the investigator). 13. Other factors judged by the investigator that make the subject unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2026-03-09 00:00:00至 To 2026-12-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-03-16 00:00:00 至 To 2026-06-16 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	6
Group：	Experimental group	Sample size：	6
干预措施：	TAN-118片	干预措施代码：
Intervention：	TAN-118 Tablets	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：	盲肠、升结肠、横结肠、降结肠、乙状结肠及直肠组织中TAN-118及其主要代谢物的浓度水平及段间分布特征	指标类型：	主要指标
Outcome：	The concentration levels and inter-segmental distribution characteristics of TAN-118 and its main metabolites in cecal, ascending colon, transverse colon, descending colon, sigmoid colon and rectal tissues.	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	升结肠、横结肠、降结肠及乙状结肠组织中TAN-118 及其主要代谢物的浓度水平及段间分布特征	指标类型：	主要指标
Outcome：	The concentration levels and inter-segmental distribution characteristics of TAN-118 and its main metabolites in the ascending colon, transverse colon, descending colon and sigmoid colon tissues.	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、PD参数和安全性终点参数	指标类型：	次要指标
Outcome：	PK parameters, PD parameters and safety endpoint 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：	肠道黏膜组织	组织：	盲肠、升结肠、横结肠、降结肠、乙状结肠及直肠
Sample Name：	Intestinal mucosal tissue	Tissue：	Appendix, ascending colon, transverse colon, descending colon, sigmoid colon and rectum
人体标本去向	使用后保存	说明	药品上市后2年
Fate of sample：	Preservation after use	Note：	Two years after the drug is marketed.

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：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

无

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

None

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：
Blinding：

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：	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：	2026-03-16 14:35:33