ChiCTR2600126669 版本V1.0 版本创建时间2026/06/13 10:36:28 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：

 ChiCTR2600126669 

最近更新日期：

Date of Last Refreshed on：

 2026-06-13 10:36:21 

注册时间：

Date of Registration：

 2026-06-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

[14C]马来酸氟诺替尼的物质平衡研究

Public title：

Material Balance Study of [14C] Flonoltinib Maleate

注册题目简写：

English Acronym：

研究课题的正式科学名称：

[14C]马来酸氟诺替尼在健康参与者中的单中心、非随机、开放、单次给药的物质平衡研究

Scientific title：

A Single-Center, Non-Randomized, Open-Label, Single-Dose Material Balance Study of [14C]Flonoltinib Maleate 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：

王方梅 

研究负责人：

缪丽燕 

Applicant：

Fangmei Wang 

Study leader：

Liyan Miao 

申请注册联系人电话：

Applicant telephone：

 +86 138 0808 6495

研究负责人电话：

Study leader's
telephone：

+86 189 1550 5252

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：

 fangmei.wang@zenitar.cn

研究负责人电子邮件：

Study leader's E-mail：

 miaolysuzhou@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：

高新区和民街16号成都前沿医学中心E3栋9F

研究负责人通讯地址：

江苏省-苏州市-苏州市平海路899号

Applicant address：

9th Floor, Building E3, Frontier Medical Center,High-tech Zone,Chengdu,Sichuan

Study leader's address：

899 Pinghai Road, Gusu District, Suzhou

申请注册联系人邮政编码：

Applicant postcode：

 610200

研究负责人邮政编码：

Study leader's postcode：

 215000

申请人所在单位：

成都赜灵生物医药科技股份有限公司

Applicant's institution：

Chengdu Zenitar Biomedical Technology Co.,Ltd.

研究负责人所在单位：

苏州大学附属第一医院

Affiliation of the Leader：

The First 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：

 (2026)伦审批第425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：

苏州大学附属第一医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the First Affiliated Hospital of Soochow University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-22 00:00:00

伦理委员会联系人：

陆周琳

Contact Name of the ethic committee：

Zhoulin Lu

伦理委员会联系地址：

苏州市姑苏区平海路899号

Contact Address of the ethic committee：

899 Pinghai Road, Gusu District, Suzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 512 6797 2861

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：

苏州大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Soochow University

研究实施负责（组长）单位地址：

苏州市姑苏区十梓街188号

Primary sponsor's address：

188 Shizi Street, Gusu District, Suzhou, Jiangsu, China

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)：

苏州

Country：

China

Province：

Jiangsu

City：

Suzhou

单位(医院)：

苏州大学附属第一医院

具体地址：

苏州市姑苏区十梓街188号

Institution
hospital：

The First Affiliated Hospital of Soochow University

Address：

188 Shizi Street, Gusu District, Suzhou, Jiangsu, China

经费或物资来源：

自筹

Source(s) of funding：

Self-raised

研究疾病：

N/A  

Target disease：

N/A

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：

主要目的 1、考察健康成年男性参与者单次口服给予[14C]马来酸氟诺替尼后，尿液和粪便中的总放射性，获得人体放射性回收率和主要排泄途径； 2、考察血浆、尿液和粪便中的放射性代谢物谱，鉴定主要代谢产物，阐明马来酸氟诺替尼在健康成年男性参与者中的主要生物转化途径； 3、考察全血和血浆中的总放射性，评价全血（如适用）和血浆中总放射性的药代动力学（PK）特征，以及全血和血浆中总放射性的分配情况。 次要目的： 1、采用已验证的液相色谱-串联质谱（LC-MS/MS）法定量分析血浆中马来酸氟诺替尼的浓度，评价血浆中马来酸氟诺替尼的PK特征； 2、评价[14C]马来酸氟诺替尼单次口服给药后在健康成年男性参与者的安全性和耐受性。  

Objectives of Study：

The primary objectives are: 1. To investigate the total radioactivity in urine and feces after a single oral administration of [14C]Flonoltinib in healthy adult male participants, thereby obtaining human radioactive recovery rates and the main excretion pathways; 2. Examine the spectrum of radioactive metabolites in plasma, urine, and feces, identify the main metabolites, and elucidate the main biotransformation pathways of fluorotinib maleate in healthy adult male participants; 3. Examine the total radioactivity in whole blood and plasma, evaluate the pharmacokinetic (PK) characteristics of total radioactivity in whole blood (if applicable) and plasma, and assess the distribution of total radioactivity in whole blood and plasma. Secondary objective: 1. To quantitatively analyze the concentration of Flonoltinib Maleate in plasma using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) and evaluate the PK characteristics of Flonoltinib Maleate in plasma; 2. Evaluate the safety and tolerability of [14C]Flonoltinib Maleate after a single oral administration in healthy adult male participants.

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.中国健康成年男性，年龄18~45周岁； 2.参与者体重不低于50 kg，体重指数（BMI）在19.0~26.0 kg/m^2之间； 3.参与者在试验期间及试验完成后无捐精计划，参与者及其伴侣在试验期间及试验完成后无生育计划且自愿采取严格的避孕措施； 4.充分了解本试验的目的和要求，自愿参加临床试验并签署书面知情同意书，能按试验要求完成全部试验过程。

Inclusion criteria

1. Chinese healthy adult male, aged 18-45 years; 2. Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m^2; 3. Participants had no plans to donate sperm during or after the trial period, and participants and their partners had no plans to have children during or after the trial period and voluntarily adopted strict contraceptive measures; 4. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.

排除标准：

1.经全面体格检查、生命体征、实验室检查（血常规、血生化、凝血功能、甲状腺功能、尿常规、粪便常规+隐血、脂肪酶、淀粉酶）、胸部X光片（正位）、肛门指检、腹部B超（肝胆胰脾肾）、眼科检查（裂隙灯、眼压和眼底摄片）、12导联心电图异常且有临床意义者； 2.筛选期心电图检查：Fridericia公式（QTcF=QT/(RR^0.33)）校正的QT间期（QTcF）>450 msec； 3.过敏体质，如已知对两种或以上物质过敏史者，或有过敏性疾病者，或对试验药物的活性成分或其制剂组分不耐受或过敏者； 4.有习惯性便秘或腹泻者，吸收不良综合征病史者，或筛选期前一周内有严重的恶心、呕吐、腹泻、便秘病史者 5.有吞咽困难或任何可能影响药物吸收的情况（例如，胃切除术、胆囊切除术、胃旁路术、十二指肠切开术、结肠切除术）者； 6.有任何临床显著慢性疾病史或研究者认为可能影响试验结果的疾病或情况，包括但不限于消化系统、心血管系统、呼吸系统、内分泌系统、神经系统、泌尿系统、肌肉骨骼系统、血液系统、免疫、精神及代谢疾病病史等； 7.既往有心脑血管病史，包括短暂性脑缺血发作、器质性心脏病、心力衰竭、心肌梗塞、心绞痛、不能解释的心律失常、扭转性室速、室性心动过速、QT延长综合征史或有QT延长综合征症状及家族史（由遗传证明或近亲在年轻时由于心脏原因猝死表明）者； 8.筛选前6个月内接受过重大手术或者手术切口没有完全愈合；重大手术包括但不限于任何有显著出血风险、延长全身麻醉期、或切开活检或明显创伤性损伤的手术者； 9.筛选时发现感冒、感染症状者； 10.乙肝表面抗原或e抗原、丙肝抗体、梅毒螺旋体抗体或人免疫缺陷病毒抗原/抗体联合检测（HIV-Ag/Ab）任一项阳性者; 11筛选前30天使用过任何导致QT间期延长的药物（如莫西沙星、氨磺必利、胺碘酮等）、CYP3A4抑制剂/诱导剂、P-gp的抑制剂/诱导剂者; 12.筛选前14天或5个半衰期（以更长者为准）内至给药前服用过任何处方药物、非处方药、中草药或食物补充剂（维生素、钙补充剂）等; 13.筛选前3个月内服用了任何临床试验药物，或参与过其他任何临床试验者; 14.筛选前3个月内曾有过失血或献血（>400 mL）者，或1个月内接受输血或血液成分者或计划在本试验结束后3个月内献血者； 15.筛选前3个月每日吸烟量大于5支（或习惯性使用含尼古丁制品）者，或在试验期间无法停止使用任何烟草产品者； 16.筛选前6个月内经常饮酒，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150 mL葡萄酒），或酒精呼气试验阳性者，或在试验期间无法禁酒者； 17.滥用药物或吸毒史，或尿液药物滥用筛查阳性者； 18.入住前48小时内进食过任何含有酒精、葡萄柚汁/西柚汁、含有甲基黄嘌呤（如咖啡、茶、可乐、巧克力、功能饮料）的食物或饮料，有剧烈运动或其他影响药物吸收、分布、代谢、排泄等因素者。或在试验期间无法停止进食任何含有酒精、葡萄柚汁/西柚汁、含有甲基黄嘌呤（如咖啡、茶、可乐、巧克力、功能饮料）的食物或饮料，无法避免剧烈运动或其他影响药物吸收、分布、代谢、排泄等因素者； 19.对饮食有特殊要求，不能遵守统一饮食者； 20.从事需长期暴露于放射性条件下的工作者，或给药前1年内有显著放射性暴露（≥2次胸/腹部CT，或≥3次其他各类X射线检查）或1年内参加过放射性药物标记试验者； 21.有晕针、晕血史者，采血困难或不能耐受静脉穿刺采血者； 22.筛选前1个月内接种过疫苗者或在试验期内计划接种疫苗者（包括但不限于新冠、流感、肺炎、带状疱疹、乙肝等疫苗）； 23.研究人员认为依从性差，或具有其他不适合参加本试验因素的参与者； 24.筛选期中性粒细胞计数、白细胞计数、血小板计数、淋巴细胞计数任一检测值低于正常参考值下限者； 25.痔疮或伴有定期/正在便血的肛周疾病。

Exclusion criteria：

1.Individuals who have undergone comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, thyroid function, urine routine, stool routine+occult blood, lipase, amylase), chest X-ray (upright), digital rectal examination, abdominal ultrasound (liver, gallbladder, pancreas, spleen, and kidney), ophthalmic examination (slit lamp, intraocular pressure, and fundus photography), and 12 lead electrocardiogram abnormalities with clinical significance; 2.Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR ^ 0.33)) corrected QT interval (QTcF)>450 milliseconds; 3.Allergic constitution, such as those with a known history of allergies to two or more substances, or those with allergic diseases, or those who are intolerant or allergic to the active ingredients of the test drug or its formulation components; 4.Individuals with habitual constipation or diarrhea, a history of malabsorption syndrome, or a history of severe nausea, vomiting, diarrhea, or constipation within the week prior to the screening period; 5.Those who have difficulty swallowing or any condition that may affect drug absorption (such as gastrectomy, cholecystectomy, gastric bypass surgery, duodenectomy, colectomy); 6. Any clinically significant history of chronic diseases or conditions that researchers believe may affect the test results, including but not limited to digestive system, cardiovascular system, respiratory system, endocrine system, nervous system, urinary system, musculoskeletal system, hematological system, immune system, psychiatric and metabolic disease history, etc.; 7.Individuals with a history of cardiovascular and cerebrovascular diseases, including transient ischemic attack, organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsional ventricular tachycardia, ventricular tachycardia, QT prolongation syndrome, or with symptoms of QT prolongation syndrome and family history (demonstrated by genetic evidence or sudden death of close relatives due to cardiac reasons at a young age); 8.Having undergone major surgery or incomplete healing of surgical incision within the previous 6 months prior to screening; Major surgeries include but are not limited to any surgery involving significant bleeding risk, prolonged general anesthesia period, or open biopsy or significant traumatic injury; 9.Discovering individuals with cold or infection symptoms during screening; 10.HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test; 11.Individuals who have used any drugs that cause QT interval prolongation (such as moxifloxacin, amisulpride, amiodarone, etc.), CYP3A4 inhibitors/inducers, P-gp inhibitors/inducers, etc. in the 30 days prior to screening; 12.Screening for any prescription drugs, over-the-counter drugs, herbal medicines, or food supplements (vitamins, calcium supplements) taken within 14 days or 5 half lives (whichever is longer) prior to administration; 13.Individuals who have taken any clinical trial medication or participated in any other clinical trial within the past 3 months prior to screening; 14.Individuals who have experienced blood loss or donated blood (>400 mL) within the previous 3 months, or who have received blood transfusions or blood components within the past 1 month, or who plan to donate blood within 3 months after the end of this trial; 15.Screening for individuals who have smoked more than 5 cigarettes per day (or habitually used nicotine containing products) in the previous 3 months, or who are unable to stop using any tobacco products during the trial period; 16.Individuals who frequently consume alcohol within the first 6 months of screening, i.e. drink more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine), or have a positive breathalyzer test, or are unable to abstain from alcohol during the trial period; 17.Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results; 18.Individuals who have consumed any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours prior to check-in, and have engaged in vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. Or those who are unable to stop eating any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) during the trial period, and cannot avoid vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc.; 19.Those who have special dietary requirements and cannot follow a uniform diet; 20.Engaged in workers who require long-term exposure to radioactive conditions, or have significant radiation exposure (>=2 chest/abdominal CT scans, or >= 3 other types of X-ray examinations) within 1 year before administration, or have participated in radiopharmaceutical labeling tests within 1 year; 21.Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection; 22.Those who have been vaccinated within one month before screening or who plan to vaccinate during the trial period (including but not limited to COVID-19, influenza, pneumonia, herpes zoster, hepatitis B and other vaccines); 23.Researchers believe that participants with poor compliance or other factors unsuitable for participation in this trial; 24.Patients with any of the following laboratory values below the lower limit of the normal reference range during the screening period: neutrophil count, white blood cell count, platelet count, or lymphocyte count; 25.Hemorrhoids or perianal diseases accompanied by regular/ongoing blood in stool.

研究实施时间：

Study execute time：

从 From 2026-04-03 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-30 00:00:00 至 To 2026-07-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 6

Group：

Experimental group

Sample size：

干预措施：

单次口服给药75 mg/100 μCi[14C]马来酸氟诺替尼

干预措施代码：

Intervention：

Single oral administration 75 mg/100 μCi [14C]Flonoltinib Maleate

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 苏州 

市(区县)：

  

Country：

China

Province：

Suzhou

City：

单位(医院)：

 苏州大学附属第一医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Soochow University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

放射性药代动力学

指标类型：

主要指标

Outcome：

Radiopharmacokinetics

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血浆、尿液、粪便样品总放射性量

指标类型：

主要指标

Outcome：

Total radioactivity of plasma, urine, and fecal samples

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药动学分析，放射性排泄分析，代谢物谱分析和主要代谢产物鉴定分析

指标类型：

主要指标

Outcome：

Pharmacokinetic analysis, radioactive excretion analysis, metabolite profiling analysis, and identification analysis of major metabolites

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件、实验室检查、生命体征、12 导联心电图、体格检查

指标类型：

次要指标

Outcome：

Adverse events, laboratory tests, vital signs, 12-lead electrocardiogram, physical examination

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：

标本中文名：

尿液

组织：

Sample Name：

Urine

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

组织：

Sample Name：

feces

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）：

不适用

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

NA

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：

Blinding：

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)：

No sharing

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：

病历记录及电子采集和管理系统, https://edc.clinflash.com/

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

Case Record Form and Electronic Data Capture, https://edc.clinflash.com/

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-13 10:36:21