ChiCTR2500114036 版本V1.0 版本创建时间2025/12/05 16:40:23 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：

ChiCTR2500114036 

最近更新日期：

Date of Last Refreshed on：

2025-12-05 16:40:18 

注册时间：

Date of Registration：

2025-12-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

在中国健康成年受试者中评价口服ABP-671片对QTc间期影响的单中心、随机、双盲、安慰剂对照临床试验

Public title：

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effect of Oral ABP-671 Tablets on QTc Intervals in Healthy Adult Subjects in China

注册题目简写：

English Acronym：

研究课题的正式科学名称：

在中国健康成年受试者中评价口服ABP-671片对QTc间期影响的单中心、随机、双盲、安慰剂对照临床试验

Scientific title：

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effect of Oral ABP-671 Tablets on QTc Intervals in Healthy Adult Subjects in China

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：

金文卿 

研究负责人：

李海燕 

Applicant：

Jin Wenqing 

Study leader：

Li Haiyan 

申请注册联系人电话：

Applicant telephone：

+86 512 6289 0812

研究负责人电话：

Study leader's telephone：

+86 10 6896 6677

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：

info@atombp.com

研究负责人电子邮件：

Study leader's E-mail：

haiyanli1027@hotmail.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：

浙江省-杭州市-钱塘江区下沙街道银海科创中心10幢201室

研究负责人通讯地址：

北京市海淀区蓝靛厂南路车道沟10号

Applicant address：

Room 201, Building 10, Yinhai Technology Innovation Center, Xiasha Street, Qiantang District, Hangzhou, Zhejiang, China

Study leader's address：

No. 10 Chedaogou, Landianchang South Road, Haidian District, Beijing, China

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：

杭州新元素药业股份有限公司

Applicant's institution：

Atom Therapeutics Co., Ltd.

研究负责人所在单位：

北京大学第三医院

Affiliation of the Leader：

Peking University Third 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：

(2025)药伦审第(354-01)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：

北京大学第三医院医学科学研究伦理委员会

Name of the ethic committee：

Peking University Third Hospital Medical Science Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025-10-27 00:00:00

伦理委员会联系人：

张老师

Contact Name of the ethic committee：

Dr. Zhang

伦理委员会联系地址：

北京市海淀区花园北路49号

Contact Address of the ethic committee：

No. 49, Huayuan North Road, Haidian District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8226 6876

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：

北京大学第三医院

Primary sponsor：

Peking University Third Hospital

研究实施负责（组长）单位地址：

北京市海淀区蓝靛厂南路车道沟10号

Primary sponsor's address：

No. 10 Chedaogou, Landianchang South Road, Haidian District, Beijing, 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)：

浙江

市(区县)：

杭州

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

杭州新元素药业股份有限公司

具体地址：

浙江省-杭州市-钱塘江区下沙街道银海科创中心10幢201室

Institution
hospital：

Atom Therapeutics Co., Ltd.

Address：

Room 201, Building 10, Yinhai Technology Innovation Center, Xiasha Street, Qiantang District, Hangzhou, Zhejiang, China

经费或物资来源：

杭州新元素药业股份有限公司

Source(s) of funding：

Atom Therapeutics Co., Ltd.

Target disease：

Gout

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：

主要目的 评价健康受试者口服ABP-671片及其代谢产物（如必要）对QTc间期的影响。 次要目的 评价健康受试者口服ABP-671片后除QTc间期外的其他心电图参数变化； 评价健康受试者口服ABP-671片后血浆ABP-671的药代动力学(PK)特征； 评价健康受试者口服ABP-671片后的安全性和耐受性。  

Objectives of Study：

Primary Objective Evaluate the effects of oral ABP-671 tablet and its metabolites (if necessary) on QTc intervals in healthy subjects. Secondary Objectives Evaluate changes in other ECG parameters (except of QTc interval) after oral administration of ABP-671 tablets in healthy subjects; Evaluate pharmacokinetic (PK) characteristics of plasma ABP-671 after oral administration of ABP-671 tablets in healthy subjects; Evaluate the safety and tolerability after oral administration of ABP-671 tablets in healthy 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：

入选标准 符合下列所有条件的受试者进入本试验： 1.自愿在本试验相关的活动开始前签署知情同意书，并能够理解本试验的程序和方法，愿意严格遵守临床试验方案完成本试验； 2.签署知情同意书时，受试者年龄在18~45岁（含两端界值），男女不限； 3.男性受试者体重≥50 kg，女性受试者体重≥45.0 kg，体重指数（BMI，计算公式：BMI＝体重/身高的平方，单位：kg/m2）在19.0~26.0 kg/m2范围内（含两端界值）； 4.筛选时的血尿酸水平在240 μmol/L~420 μmol/L（含240和420）之间，并且无痛风病史； 5.受试者从签署知情同意书开始直至末次服药后3个月内无生育计划且自愿采取有效避孕措施且无捐精、捐卵计划； 6.能够和研究者进行良好的沟通，并且理解和遵守本项研究的各项要求。

Inclusion criteria

Inclusion Criteria Subjects must meet all the following inclusion criteria to be eligible for this trial: 1.Voluntarily sign a written informed consent form before the initiation of activities related to the trial, understand the procedures and methods of the trial, and be willing to complete the trial in strict accordance with the clinical trial protocol; 2.Males or females aged between 18 (inclusive) and 45 (inclusive) years at the time of signing the informed consent form; 3.Male subject weight >= 50 kg, female subject weight >= 45.0 kg; BMI (BMI, calculated as BMI = weight/height squared, Unit: kg/m2) is between 19.0 (inclusive) and 26.0 (inclusive) kg/m2; 4.Blood uric acid (UA) level at screening is between 240 μmol/L (inclusive) and 420 μmol/L (inclusive) and the subject has no medical history of gout; 5.Those who have no family planning from the time of signing the informed consent form to within 3 months after the last dose and who volunteer to use effective contraceptive methods and have no plan as sperm or egg donor. 6.Be able to communicate well with the investigators and understand and comply with the requirements of the trial.

排除标准：

排除标准： 符合下列条件之一的受试者将不得入选试验： 1.已知对ABP-671或及相关辅料或同类药物有过敏史，或对其他药物、食物、环境过敏或过敏体质者，或有特应性变态反应性疾病史者（如哮喘、荨麻疹、湿疹性皮炎等）； 2.体格检查、生命体征、心电图、腹部B超（肝胆胰脾双肾及双侧输尿管）、胸部X线检查（正侧位）、实验室检查等各项检查异常有临床意义者（以临床医师判断为准）； 3.有慢性疾病者，包括但不限于呼吸系统、消化系统、心血管系统、泌尿系统、血液系统、内分泌系统、免疫系统等相关疾病； 4.有高钾血症、低钾血症、高镁血症、低镁血症、高钙血症或低钙血症等电解质代谢紊乱且经研究者判断有临床意义者； 5.曾有尖端扭转型室性心动过速的其他危险因素，或有短QT综合征、长QT综合征家族史，或家族中有青年时期（≤40岁）原因不明猝死的一级亲属（即亲生父母、兄弟姐妹或孩子）者； 6.筛选时12导联心电图检查，允许一次复测：经Fridericia校正的QT间期（QTcF）≥450 ms【Fridericia公式QTcF=QT/（RR^0.33）计算】，或QRS≥120 ms，或PR≥200ms，且经研究者判断心电图异常且有临床意义者；； 7.筛选时乙型肝炎表面抗原、丙型肝炎病毒抗体、人类免疫缺陷病毒抗体、梅毒螺旋体特异性抗体任意一项检查结果为阳性者； 8.首次给药前3个月内参加过任何药物和医疗器械的临床试验者，或者筛选前仍在某项临床研究的随访期内或试验药物5个半衰期内（以较长者为准）； 9.首次给药前6个月内接受过经研究者判断会影响药物吸收、分布、代谢、排泄的手术者；或首次给药前4周内接受过外科手术；或计划在试验期间进行外科手术者； 10.首次给药前14天内使用过任何药物者（包括中草药、保健品等），或计划在试验期间服用（本试验中的试验药物、安慰剂和碳酸氢钠片除外）； 11.首次给药前3个月内献血或大量失血（＞400 mL）者，或接受过输血或使用过血制品者，或打算在试验期间或试验结束后3个月内献血或血液成份者； 12.有药物滥用史（包括非医疗目的反复、大量地使用各类麻醉药品和精神药品），或尿液药物滥用筛查任意一项呈阳性者； 13.嗜烟者或首次给药前3个月每日吸烟量多于5支者，或试验期间不能停止使用任何烟草类产品者； 14.酗酒者或首次给药前6个月内经常饮酒者，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），或试验期间不愿意停止饮酒或任何含酒精的制品，或酒精呼气试验结果大于0.0 mg/100 mL者； 15.每天饮用浓茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯=250 mL）者，或不同意试验期间停止饮用茶、咖啡和/或含咖啡因的饮料者； 16.首次给药前7天内，进食了任何包含葡萄柚的饮料或食物，或首次给药前48 h内进食了任何包含咖啡因的饮料或食物，如咖啡、茶、可乐、巧克力等；或不同意试验期间停止进食上述饮食者； 17.首次给药前4周内接种过疫苗者或计划在试验期间接种疫苗者； 18.对饮食有特殊要求，不能遵守统一饮食者； 19.不能耐受静脉穿剌或有晕血、晕针史者； 20.受试者可能因为其他原因而不能完成本研究或经研究者判断具有其它不宜参加试验原因者。

Exclusion criteria：

Exclusion criteria Subjects who meet any of the following criteria will be excluded from the trial: 1.Known to have a history of allergies to ABP-671 or its related excipients or equivalent drugs, or have allergies to other drugs, foods and the environment, or be allergic constitution, or have a history of atopic allergic disease (e.g. asthma, urticaria, eczematous dermatitis, etc.); 2.Physical examination, vital signs, electrocardiogram (ECG), abdomen ultrasound (liver, gallbladder, pancreas, spleen, kidneys and bilateral ureters), chest PA & LAT x-ray examination, laboratory tests and other examinations are abnormal but clinically significant (subject to the clinician's judgment); 3.Those with chronic diseases, including but not limited to the respiratory system, digestive system, cardiovascular system, urological system, blood system, endocrine system, the immune system, etc.; 4.Those with electrolyte metabolic disorders such as hyperkalemia, hypokalemia, hypermagnesaemia, hypomagnesaemia, hypercalcemia, hypocalcemia, etc. and those with clinical significance judged by the investigator; 5.Those who had other risk factors for ventricular tachycardia with Torsades de Pointes (twisting of the points), or have a family history of short QT syndrome or long QT syndrome, or whose first degree relatives (i.e., biological parents, siblings, or children) in a family have sudden death of unknown cause in their youth (<= 40 years); 6.12-Lead ECG at screening and one re-test permitted: Corrected QT interval using Fridericia’s formula (QTcF) >= 450 ms [Fridericia formula QTcF=QT/ (RR^0.33) calculation], or QRS>= 120 ms, or PR>= 200 ms, and with abnormality but clinical significance judged by the investigator; 7.Those with positive results at screening for any of the hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody, and treponema pallidum-specific antibody tests; 8.Those who had participated in a clinical trial of any drug or medical device within 3 months before the first dose, or who were in the follow-up visit period of a clinical study or within 5 half-lives of a trial drug before screening, whichever is longer; 9.Those who had undergone surgery within 6 months before the first dose, according to the investigator's judgment, would affect absorption, distribution, metabolism, or excretion of the trial drug; or who had undergone surgery within 4 weeks before the first dose; or who plan to undergo surgery during the trial; 10.Those who have used any medication (including Chinese herbs, health care products, etc.) within 14 days before the first dose of the trial drug or plan to take it during the trial (except the trial drug, placebo and sodium bicarbonate tablet in this trial); 11.Those who have donated blood or a large amount of blood loss (> 400 mL) within 3 months before the first dose, or who have received a blood transfusion or used blood products, or who intend to donate blood or blood components during the trial or within 3 months after the end of the trial; 12.Those with a history of drug abuse (including repeated and substantial use of various narcotic drugs and psychotropic substances for non-medical purposes) or positive for any of urine drug abuse screens; 13.Heavy smokers or those who smoked more than 5 cigarettes per day within 3 months before the first dose, or those who are unable to abstain from any tobacco products during the trial; 14.Alcoholics or regular drinkers within 6 months before the first dose, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL 40% spirit or 150 mL wine); or those who are not willing to stop drinking or any alcohol-containing product during the trial, or whose alcohol breath test results are greater than 0.0 mg/100 mL; 15.Those who drink strong tea, coffee and/or caffeine-containing beverages daily (not less than 8 cups, 1 cup = 250 mL) or disagree with stopping drinking tea, coffee and/or caffeine-containing beverages during the trial; 16.Any grapefruit-containing beverage or food consumption within 7 days before the first dose, or any caffeine-containing beverage or food such as coffee, tea, cola, chocolate, etc. consumption within 48 h before the first dose; or those who disagree to stop consumption of the above-mentioned beverages or foods during the trial; 17.Those who have received vaccine within 4 weeks before the first dose or plan to receive vaccine during the trial; 18.Those who have special dietary requirements and cannot comply with a uniform diet; 19.Intolerant of venous puncture or a history of hemophobia or trypanophobia; 20.Subjects may not be able to complete the trial for other reasons or have other reasons judged by the investigators to be unsuitable for participation in the trial.

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2026-03-20 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-12-15 00:00:00 至 To 2026-01-08 00:00:00  

干预措施：

Interventions：

组别：

ABP-671试验药物组

样本量：

12

Group：

ABP-671 group

Sample size：

干预措施：

试验药物采用剂量递增给药，即D1~D3为0.5 mg，D4~D6为1 mg，D7~D9为4 mg，D10~D12为8 mg，给药频率为每天一次

干预措施代码：

Intervention：

The investigational product will be administered in an escalating dose regimen as follows: 0.5 mg on Days 1-3, 1 mg on Days 4-6, 4 mg on Days 7-9, and 8 mg on Days 10-12, with a dosing frequency of once daily

Intervention code：

组别：

安慰剂组

样本量：

8

Group：

Placebo group

Sample size：

干预措施：

安慰剂组的给药剂量和给药频率同试验药物组

干预措施代码：

Intervention：

The placebo group will follow an identical dosing schedule (both in amount and frequency) as the investigational drug group

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)：

 北京 

Country：

China 

Province：

Beijing 

City：

Beijing 

单位(医院)：

北京大学第三医院 

单位级别：

三甲 

Institution
hospital：

Peking University Third Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

经基线及安慰剂校正的QTcF

指标类型：

主要指标

Outcome：

Baseline- and placebo-corrected QTcF

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心电图参数

指标类型：

次要指标

Outcome：

Electrocardiogram (ECG) 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：

血浆PK

指标类型：

次要指标

Outcome：

Plasma PK

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安全性和耐受性指标

指标类型：

次要指标

Outcome：

Safety and tolerability endpoints

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：

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）：

由随机化统计师采用区组随机化方法，以SAS软件（9.4版本）产生随机号和随机号所对应的组别

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

The randomization statistician will use the block randomization method to generate random codes and their corresponding group assignments with SAS software (version 9.4).

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：

本试验采用双盲设计，即所有研究者、研究中心人员、受试者、申办者以及负责此临床试验的相关人员均不知晓每位受试者接受的是哪种试验用药物（ABP-671片或安慰剂）。

Blinding：

This trial employs a double-blind design, meaning that all investigators, site staff, subjects, the sponsor, and other personnel involved in the conduct of this clinical trial are unaware of which investigational product (ABP-671 tablets or placebo) each subject has been assigned to receive.

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

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：

采用EDC收集临床试验数据

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

EDC will be used for clinical trial data collection.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-12-05 16:40:18