ChiCTR2500102975 版本V1.0 版本创建时间2025/05/22 11:35:08 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：

 ChiCTR2500102975 

最近更新日期：

Date of Last Refreshed on：

 2025-05-22 11:35:03 

注册时间：

Date of Registration：

 2025-05-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价tinlarebant在中国成年健康志愿者中的药代动力学、药效动力学的开放、多次给药Ⅰb期临床研究

Public title：

A Phase 1b, Open-Label, Repeat Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of tinlarebant in Chinese Healthy Adult Participants

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价tinlarebant在中国成年健康志愿者中的药代动力学、药效动力学的开放、多次给药Ⅰb期临床研究

Scientific title：

A Phase 1b, Open-Label, Repeat Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of tinlarebant in Chinese Healthy Adult Participants

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：

Nina Hou 

研究负责人：

卢来春 

Applicant：

Nina Hou 

Study leader：

Lu Laichun 

申请注册联系人电话：

Applicant telephone：

 +86 199 3737 5561

研究负责人电话：

Study leader's
telephone：

+86 138 8393 3701

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：

 Ninahou@belitebio.com

研究负责人电子邮件：

Study leader's E-mail：

 lulaicq@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：

上海市-上海市-中国(上海)自由贸易试验区金科路4560号

研究负责人通讯地址：

北京市东城区东交民巷1号

Applicant address：

No. 4560 Jinke Road, Shanghai-Shanghai-China (Shanghai) Pilot Free Trade Zone

Study leader's address：

No. 1, Dongjiaomin Lane, Dongcheng District, Beijing

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：

倍亮生技医药(上海)有限公司

Applicant's institution：

Belite Bio (Shanghai) Limited

研究负责人所在单位：

首都医科大学附属北京同仁医院

Affiliation of the Leader：

Beijing Tongren Hospita

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：

 TREC2025-042

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：

首都医科大学附属北京同仁医院伦理委员会

Name of the ethic committee：

Ethics Committee of Beijing Tongren Hospital affiliated to Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-17 00:00:00

伦理委员会联系人：

武峰

Contact Name of the ethic committee：

Wu Feng

伦理委员会联系地址：

北京市东城区东交民巷1号

Contact Address of the ethic committee：

No. 1, Dongjiaomin Lane, Dongcheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 159 1096 1255

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 bjtrec@126.com

研究实施负责（组长）单位：

首都医科大学附属北京同仁医院

Primary sponsor：

Beijing Tongren Hospital Affiliated to Capital Medical University

研究实施负责（组长）单位地址：

北京市东城区东交民巷1号

Primary sponsor's address：

No. 1, Dongjiaomin Lane, Dongcheng District, Beijing

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)：

上海

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

倍亮生技医药(上海)有限公司

具体地址：

上海市-上海市-中国(上海)自由贸易试验区金科路4560号

Institution
hospital：

Belite Bio (Shanghai) Limited

Address：

No. 4560 Jinke Road, Shanghai-Shanghai-China (Shanghai) Pilot Free Trade Zone

经费或物资来源：

本项目的研究经费均由申办方承担

Source(s) of funding：

The research funds of this project will be borne by the sponsor

研究疾病：

地图样萎缩（GA）和1型Stargardt病（STGD1） 研  

Target disease：

GA and STGD1

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.评价中国健康志愿者连续7天口服tinlarebant 5mg后的药代动力学特征； 2.评价中国健康志愿者连续7天口服tinlarebant 5mg后的药效学指标视黄醇结合蛋白4（retinol binding protein 4, RBP4）在血浆中的浓度水平。 次要目的： 1.观察健康志愿者多次口服tinlarebant后的系统安全性和耐受性。  

Objectives of Study：

Primary study objectives: 1.To determine the pharmacokinetics (PK) following daily oral 5 mg tinlarebant for 7 days in healthy Chinese participants. 2.To measure the concentrations of retinol binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following daily oral 5 mg tinlarebant for 7 days in healthy Chinese participants. Secondary study objectives: 3.To investigate the systemic safety and tolerability following multiple oral doses of tinlarebant in healthy Chinese 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.在开展任何研究相关活动之前提供书面知情同意书，并且必须能够充分理解试验的性质和目的，包括可能的风险和不良反应。 2.18至65岁之间的健康男性或女性，单一性别比例不低于1/3。 3.筛选时体重指数（BMI）19.0~28.0 kg/m^2（含边界值），男性参与者体重>=50 kg、女性参与者体重>=45 kg。 4. 根据研究前的病史与无临床显著异常，经研究者判断为健康志愿者，包括： a) 体格检查，无异常或异常无临床意义； b) 收缩压在90至139 mmHg范围内，舒张压在60至89 mmHg范围内，或异常无临床意义； c) 脉搏在60至100次/分钟范围内，或异常无临床意义； d) 体温无异常或异常无临床意义； e) 无临床显著异常的心电图（ECG），包括经Fredericia校正的QT间期（QTcF，QTcF = QT/RR1/3）男性参与者< 450 ms，女性参与者<470 ms； f) 血常规、尿常规、血生化、凝血功能正常或经研究者判断异常无临床意义； 5.女性参与者必须无生育能力，即已接受手术绝育（至少在筛选访视前6周及以上接受子宫切除术、双侧输卵管切除术、双侧卵巢切除术）或已绝经（绝经定义为无其他医学原因的12个月无月经并且促卵泡激素（FSH）与绝经后状态一致，≥40 mUL/mL或根据当地实验室指南)，或如果具有生育能力： a) 筛选前14天内，与男性伴侣未发生无保护性行为。 b) 筛选访视时必须妊娠检查结果阴性。 c) 必须同意从签署知情同意书之日起至研究药物末次给药后至少89天(30天+5倍半衰期）后不捐卵或尝试怀孕。 d) 如果不是同性关系，必须同意适当的避孕措施(定义为男性伴侣使用避孕套并使用高效避孕方法（详见方案附录3）)，并且末次接受试验药物至少89天内不得捐献卵子。 6.男性参与者必须： a) 同意从签署知情同意书之日起至研究药物末次给药后至少149天内不捐精。 b) 如果与可能怀孕的女性伴侣发生性行为，必须同意使用适当的避孕措施（定义为从签署知情同意书开始至研究药物末次给药后至少149天使用安全套和高效避孕方法（详见方案附录3）。 c) 与非育龄期女性或同性伴侣发生性行为，必须同意从签署知情同意书时起至研究药物末次给药后至少149天内使用安全套。 7.愿意并能够遵守所有计划访视、给药计划、临床实验室检查和其他研究程序。

Inclusion criteria

1. Provide written informed consent prior to undertaking any study-related activities and must be able to fully understand the nature and purpose of the trial, including possible risks and adverse effects. 2. Healthy males or females between the ages of 18 and 65, with a single sex ratio of not less than 1/3. 3. Body mass index (BMI) 19.0~28.0 kg/m^2 (including boundary value) at screening, weight >=50 kg for male participants and > weight for female participants =45 kg. 4. Healthy volunteers judged by the investigator based on the medical history and no clinically significant abnormalities before the study, including: a) Physical examination, no abnormalities or abnormalities not clinically significant; b) systolic blood pressure in the range of 90 to 139 mmHg and diastolic blood pressure in the range of 60 to 89 mmHg, or abnormality not clinically significant; c) Pulse in the range of 60 to 100 beats/minute, or abnormally non-clinically significant; d) There is no abnormality in body temperature or abnormality is not clinically significant; e) Electrocardiogram (ECG) without clinically significant abnormalities, including Fredericia-corrected QT interval (QTcF, QTcF = QT/RR1/3) for male participants < 450 ms and female participants <470 ms; f) The blood routine, urine routine, blood biochemistry, and coagulation function are normal or abnormal as judged by the investigator to be clinically significant; 5. Female participants must be of non-childbearing potential, i.e., have undergone surgical sterilization (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks and more prior to the screening visit) or be postmenopausal (menopause is defined as 12 months without menses without an alternative medical cause and follicle-stimulating hormone (FSH) consistent with postmenopausal status ≥ 40 mUL/mL or according to local laboratory guidelines), or if of childbearing potential: a) No unprotected sex with a male partner within 14 days prior to screening. b) Must have a negative pregnancy test result at the screening visit. c) Must agree not to donate eggs or attempt to conceive from the date of signing the informed consent form until at least 89 days (30 days 5-fold-half-life) after the last dose of study drug. d) If not in a same-sex relationship, must agree to adequate contraception (defined as the use of a condom by the male partner and the use of a highly effective contraceptive method (see Appendix 3 of the protocol for details)) and must not donate eggs for at least 89 days after the last dose of the trial drug. 6. Male participants must: a) Agree not to donate sperm from the date of signing the informed consent form until at least 149 days after the last dose of study drug. b) If sexually active with a female partner who may become pregnant, must agree to use adequate contraception (defined as the use of condoms and highly effective contraceptive methods from the time of signing the informed consent form until at least 149 days after the last dose of study drug (see Appendix 3 of the protocol for details). c) Sexual activity with a non-childbearing female or same-sex partner must agree to use a condom from the time of signing the informed consent form until at least 149 days after the last dose of study drug. 7. Willing and able to comply with all scheduled visits, dosing schedules, clinical laboratory tests, and other study procedures.

排除标准：

1.已知或疑似对试验用药品或其中任一成分过敏者或有其他具有临床意义的反应。 2.经研究者判断存在临床显著的医学或精神疾病史（例如，心脏血管、呼吸系统、肝脏、胃肠道、肾脏、泌尿生殖系统、内分泌、神经肌肉、风湿病、肿瘤、皮肤或其他疾病）。 3.经研究者判断任何可能影响研究结果或因参与者参与研究而对参与者造成额外风险的疾病史。 4.经研究者判断存在任何具有临床意义的、持续的全身性细菌、真菌或病毒性感染（包括上呼吸道感染，但不包括局部皮肤真菌感染）。 5.在首次给药前30天内接受过任何重大手术史。 6.筛选前28天内每日吸烟量大于5支或习惯性使用含尼古丁制品者，或在研究药物给药前5天内不愿意戒烟，或研究期间不愿意戒烟。 7.经研究者判定既往或目前存在有临床意义的甲状腺疾病史，筛选时促甲状腺激素（TSH）水平超出正常范围者。 8.酗酒或筛选前6个月内经常饮酒者，即每周饮酒超过14个单位的酒精（1单位=360 mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒），或筛选期时酒精呼气试验结果阳性者，或在使用研究药物前48小时内饮酒者，或在试验期间无法戒断酒精者。 9.滥用药物或筛选前6个月使用过软毒品（如：大麻）或筛选前1年服用硬毒品（如：苯丙胺类、苯环己哌啶等）者；或筛选期尿药检测阳性者。 10.筛选期存在乙肝病毒感染者；或丙型肝炎病毒（HCV）抗体阳性；或人类免疫缺陷病毒（HIV）抗体阳性；或梅毒螺旋体抗体阳性。 11.筛选时血红蛋白水平低于正常下限且有临床意义。 12.于规定期间使用过及试验期间无法避免或计划使用下述处方药、非处方药、中草药或补充剂者： a) 任何含有全身性处方维生素A或维生素A衍生物的药物（包括口服、注射及眼科药物）。在筛选前至少30天或在药物的洗脱期内停用，以时间较长者为准。含有维生素A或维生素A衍生物的其他局部药物是允许的。 b) 任何非处方含维生素A或维生素A衍生物的补充剂。在筛选前至少30天或在药物的洗脱期内停用，以时间较长者为准。 c) 任何已知的细胞色素P450酶抑制剂/诱导剂药物或补充剂（如克拉霉素、氟伏沙明、酮康唑、利福平、卡马西平、圣约翰草）。在首次研究给药前至少30天内停止使用；或在首次研究给药后48小时内开始定期食用影响细胞色素P450酶活性的食物（如葡萄柚、石榴、杨桃、苦橙[塞维利亚橙]），且研究者认为可能会影响参与者的安全性或研究结果的有效性。(参见附录4) 13.在首次给药前56天内献血或发生过失血>=400 mL。 14.首次给药前7天内捐献血浆。 15.筛选前3个月内参加过任何临床试验且接受过试验用药品或使用过试验用器械者。 16.研究者认为具有任何不宜参加本研究的其他因素。

Exclusion criteria：

1. Known or suspected allergy to the investigational drug or any of its components or other clinically significant reactions. 2. History of clinically significant medical or psychiatric illness (e.g., cardiovascular, respiratory, hepatic, gastrointestinal, renal, genitourinary, endocrine, neuromuscular, rheumatology, tumor, cutaneous, or other diseases) as judged by the investigator. 3. History of any disease that, as judged by the investigator, may affect the results of the study or pose an additional risk to the participant as a result of the participant's participation in the study. 4. Presence of any clinically significant, ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection, but excluding local skin fungal infection) as judged by the investigator. 5. History of any major surgery within 30 days prior to the first dose. 6. Those who smoke more than 5 cigarettes per day within 28 days before screening or habitually use nicotine-containing products, or are unwilling to quit smoking within 5 days before the administration of the study drug, or are unwilling to quit smoking during the study. 7. Those who have a history of clinically significant thyroid disease in the past or at present as judged by the investigator, and the thyroid-stimulating hormone (TSH) level is beyond the normal range at screening. 8. Alcoholism or regular drinkers within 6 months prior to screening, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine), or those who have a positive alcohol breath test result during the screening period, or those who have consumed alcohol within 48 hours prior to the use of the study drug, or those who are unable to abstain from alcohol during the trial. 9. Those who abused drugs or used soft drugs (such as marijuana) in the 6 months before screening or took hard drugs (such as amphetamines, phencyclidine and piperidine) in the 1 year before screening; or those who have a positive urine drug test during the screening period. 10. Those with hepatitis B virus infection during the screening period; or positive hepatitis C virus (HCV) antibodies; or positive for human immunodeficiency virus (HIV) antibodies; or positive Treponema pallidum antibodies. 11. The hemoglobin level was lower than the lower limit of normal at screening and was clinically significant. 12. Those who have used the following prescription drugs, over-the-counter drugs, Chinese herbal medicines or supplements during the specified period and cannot avoid or plan to use them during the trial period: a) Any medication (including oral, injectable and ophthalmic drugs) containing systemic prescription vitamin A or vitamin A derivatives. Discontinued at least 30 days prior to screening or during the washout period of the drug, whichever is longer. Other topical medications containing vitamin A or vitamin A derivatives are permitted. b) Any over-the-counter supplement containing vitamin A or vitamin A derivatives. Discontinued at least 30 days prior to screening or during the washout period of the drug, whichever is longer. c) Any known cytochrome P450 enzyme inhibitor/inducer medication or supplement (e.g., clarithromycin, fluvoxamine, ketoconazole, rifampicin, carbamazepine, St. John's wort). Discontinuation of use within at least 30 days prior to the first study dose; or regular consumption of foods that affect cytochrome P450 enzyme activity (e.g., grapefruit, pomegranate, star fruit, bitter orange [Seville orange]) within 48 hours of the first study dose and which, in the opinion of the investigator, may affect the safety of the participant or the validity of the study results. (See Appendix 4) 13. Blood donation or blood loss within 56 days prior to the first dose>=400 mL. 14. Donation of plasma within 7 days prior to the first dose. 15. Those who have participated in any clinical trial within 3 months before screening and have received investigational drugs or used investigational devices. 16. Any other factors that, in the opinion of the investigator, are not suitable to participate in this study.

研究实施时间：

Study execute time：

从 From 2025-05-31 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-05-31 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 8

Group：

Experimental group

Sample size：

干预措施：

D1-D7每日一次，每次5 mg。

干预措施代码：

Intervention：

Oral administration, D1-D7 once daily, 5 mg each time.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京  

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 首都医科大学附属北京同仁医院 

单位级别：

 三甲 

Institution
hospital：

Beijing Tongren Hospital, Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

药代动力学

指标类型：

主要指标

Outcome：

Pharmacokinetics

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药效学

指标类型：

主要指标

Outcome：

Pharmacodynamics

Type：

Primary 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 65 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）：

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：

无

Blinding：

None

是否共享原始数据：

IPD sharing

是Yes

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）：

论文发表后半年内，通过 http://www.medresman.org.cn/login.aspx共享。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Within half a year after the publication of the paper, it will be shared through http://www.medresman.org.cn/login.aspx.

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：

  2025-05-22 11:35:03