ChiCTR2500115436 版本V1.1 版本创建时间2025/12/26 08:28:10 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：

ChiCTR2500115436 

最近更新日期：

Date of Last Refreshed on：

2025-12-26 08:27:49 

注册时间：

Date of Registration：

2025-12-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价 YZJ-4729 酒石酸盐注射液单次给药的安全性、耐受性、药代动力学及对 QT 间期影响的临床试验

Public title：

A Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and QT Interval Effects of a Single Dose of YZJ-4729 Tartrate Injection

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价 YZJ-4729 酒石酸盐注射液单次给药的安全性、耐受性、药代动力学及对 QT 间期影响的临床试验

Scientific title：

A Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and QT Interval Effects of a Single Dose of YZJ-4729 Tartrate Injection

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：

黄洁 

研究负责人：

阳国平 

Applicant：

Huang Jie 

Study leader：

Yang Guo Ping 

申请注册联系人电话：

Applicant telephone：

+86 731 8991 8665

研究负责人电话：

Study leader's telephone：

+86 731 8991 8665

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：

cellahuang1988@163.com

研究负责人电子邮件：

Study leader's E-mail：

ygp9880@126.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：

中国湖南省长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Applicant address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

Study leader's address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, 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：

中南大学湘雅三医院

Applicant's institution：

The Third Xiangya Hospital, Central South University

研究负责人所在单位：

中南大学湘雅三医院

Affiliation of the Leader：

The Third Xiangya Hospital, Central South University

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：

25206

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：

中南大学湘雅三医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Third Xiangya Hospital, Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-20 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Wang Xiaomin

伦理委员会联系地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Contact Address of the ethic committee：

No. 138 Tongzipo Road, Yuelu District, Changsha, Hunan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 731 8861 8938

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：

中南大学湘雅三医院

Primary sponsor：

The Third Xiangya Hospital, Central South University

研究实施负责（组长）单位地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

No. 138 Tongzipo Road, Yuelu District, Changsha, Hunan, 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)：

湖南

市(区县)：

Country：

China

Province：

Human

City：

单位(医院)：

中南大学湘雅三医院

具体地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Institution
hospital：

The Third Xiangya Hospital of Central South University

Address：

No. 138 Tongzipo Road, Yuelu District, Changsha, Hunan, China

经费或物资来源：

上海海雁医药科技有限公司

Source(s) of funding：

Shanghai Haiyan Pharmaceutical Technology Co., Ltd

Target disease：

Pain

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评估 YZJ-4729 酒石酸盐药物浓度-QT 间期（C-QTc）变化关系及对试验参与者QT 间期的影响； 评价 YZJ-4729 酒石酸盐注射液单次给药的药代动力学特征； 评价 YZJ-4729 酒石酸盐注射液单次给药的安全性和耐受性。  

Objectives of Study：

Evaluate the relationship between YZJ-4729 tartrate drug concentration and QT interval (C-QTc) changes, as well as its impact on the QT interval of trial participants; Evaluate the pharmacokinetic characteristics of single dose administration of YZJ-4729 tartrate injection; Evaluate the safety and tolerability of single dose administration of YZJ-4729 tartrate injection.

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) 年龄在 18~45 周岁（包括临界值）的男性或女性试验参与者； 2) 男性试验参与者体重不低于 50kg、女性试验参与者体重不低于 45kg。身体质量指数（BMI）=体重（kg）/身高 ^2（m^2），BMI在19.0~26.0kg/m^2 范围内（包括临界值）； 3) 有生育能力的女性试验参与者从筛选前 2 周至最后一次给药后 90 天内，男性试验参与者（伴侣为有生育能力的女性）从签署知情同意书至最后一次给药后 90 天内，无生育计划并采取适当避孕措施（避孕措施见附录 2：避孕措施、育龄女性的定义和避孕要求），且避免捐献卵子/精子； 4) 能够理解并愿意严格遵守临床试验方案完成本试验，签署知情同意书的试验参与者。

Inclusion criteria

1) Male or female participants aged 18 to 45 years old (including the threshold) in the trial; 2) The weight of male trial participants shall not be less than 50kg, and the weight of female trial participants shall not be less than 45kg. Body Mass Index (BMI)=weight (kg)/height ^2 (m^2), with BMI ranging from 19.0 to 26.0kg/m^2 (including critical values); 3) Female trial participants with fertility have no fertility plan and have taken appropriate contraceptive measures (see Appendix 2: Contraceptive Measures, Definition of Women of Childbearing Age, and Contraceptive Requirements) from 2 weeks before screening to 90 days after the last administration, and male trial participants (with a partner who is a fertile female) have not signed the informed consent form and have taken appropriate contraceptive measures (see Appendix 2: Contraceptive Measures, Definition of Women of Childbearing Age, and Contraceptive Requirements) within 90 days after the last administration, and have avoided donating eggs/sperm; 4) Participants who can understand and are willing to strictly follow the clinical trial protocol to complete this trial and sign the informed consent form.

排除标准：

1) 过敏体质，如已知对两种或以上物质有过敏史者，或已知对阿片类药物过敏者，或者存在应用此类药物的禁忌症者，或已知对 YZJ-4729酒石酸盐注射液及其辅料有过敏史者； 2) 既往或现患有呼吸系统（如困难气道、睡眠呼吸暂停低通气综合征）、消化系统（如胃肠道梗阻）、泌尿系统、内分泌系统、神经系统（如癫痫）、血液学、免疫学、精神病学等系统疾病且经研究者判定不适合入组者； 3) 有心血管系统病史包括但不限于晕厥病史或家族史、冠心病（如冠脉造影诊断冠心病、急性冠脉综合征史、心梗史等）、瓣膜性心脏病、心力衰竭、非药物所致缓慢性心律失常病史、频发室性早搏、室速等病史者；或既往 QTc 间期延长或曾有尖端扭转型室性心动过速的其他危险因素（低钾血症等），或有短 QT 综合征、长QT 综合征、青年时期（＜＝40 岁）原因不明的猝死、溺死或婴儿猝死综合征的一级亲属（即亲生父母、兄弟姐妹或孩子）家族史者； 4) 有症状的头部外伤病史者； 5) 任何病因或药物引起的频发恶心或呕吐史者； 6) 对饮食有特殊要求、不能遵守统一饮食者； 7) 有晕针晕血史或其他因素（如不能耐受静脉穿刺）导致的采血困难者； 8) 乙型肝炎病毒表面抗原、丙型肝炎病毒抗体、人免疫缺陷病毒抗体、梅毒螺旋体抗体任何一项异常有临床意义者； 9) 筛选时生命体征（收缩压<90mmHg 或>140mmHg，舒张压<50mmHg 或>90mmHg；呼吸<12 次/分或>20 次/分；脉搏<60 次/分或>100 次/分）、体格检查、12-导联心电图、实验室检查（血常规、血生化、尿常规、凝血功能）、胸正位片或 CT、腹部彩超结果，研究者判断异常有临床意义且经研究者判定不适合入组者； 10) 筛选时经皮血氧饱和度<95%； 11) 筛选时心电图检查结果异常有临床意义，如男性QTc＞＝450ms，女性QTc＞＝460ms[QTc以Fridericia公式计算：QTcF=QT/(RR^0.33)]；PR 间期＞＝200ms；QRS持续时间＞＝120ms； 12) 筛选时血钾、血镁、血钙超出正常参考范围上限或低于正常参考范围下限者； 13) 既往有任何药物滥用史或筛选期尿液药物筛查阳性者； 14) 在筛选前 6 个月内接受过重大手术或接受了可能显著影响试验用药品体内过程或安全性评价的手术者； 15) 筛选前 6 个月内经常饮酒者，即每周饮酒超过14单位酒精（1 单位≈360mL 啤酒或45mL 酒精量为 40%的烈酒或 150mL 葡萄酒）或试验期间不能停止使用任何酒精类产品者，或入住时酒精呼气测试结果大于 0.0mg/100mL 者； 16) 筛选前 3 个月内每日吸烟量＞＝5 支或等量烟草制品，或试验期间不能停止使用任何烟草制品者； 17) 筛选前 3 个月内献血或大量失血（>400mL），接受输血或使用血制品者，或计划在试验期间或试验结束后 1 个月内献血者； 18) 筛选前 3 个月内每天饮用过量茶、咖啡和/或含咖啡因的饮料（8 杯以上，1 杯=250mL）者； 19) 筛选前 3 个月内参加任何临床试验并接受了试验用药品或医疗器械者，或计划在试验期间参加其他临床试验者； 20) 筛选前 30 天内接受过疫苗接种或计划在试验期间接种疫苗者； 21) 筛选前 28 天或在试验期间拟合并服用任何改变肝 CYP2C9、CYP3A4 酶活性的药物，包括影响肝代谢酶的强烈抑制剂和诱导剂或导致 QT/QTc 间期延长的药物（具体药物信息见附录 3：已知可抑制、诱导 CYP 肝酶活性的药物及可能延长 QT 间期的药物等）； 22) 入住前 14 天内服用过任何处方药、非处方药、保健品、维生素、中药者； 23) 入住前 7 天内，服用过特殊饮食，如杨桃、葡萄柚、柚子、火龙果、芒果或相关产品（如含葡萄柚的饮料）； 24) 入住前 48h 内摄取了巧克力、任何含咖啡因或富含黄嘌呤成分的食物者； 25) 女性试验参与者处于哺乳期或妊娠结果阳性者； 26) 从筛选阶段至随机前发生急性疾病者； 27) 研究者认为不应纳入者。

Exclusion criteria：

1) Allergic constitution, such as those known to have a history of allergies to two or more substances, or those known to be allergic to opioid drugs, or those with contraindications to the use of such drugs, or those known to have a history of allergies to YZJ-4729 tartrate injection and its excipients; 2) Individuals who have previously or currently suffered from respiratory system diseases (such as difficult airways, sleep apnea hypopnea syndrome), digestive system diseases (such as gastrointestinal obstruction), urinary system diseases, endocrine system diseases, nervous system diseases (such as epilepsy), hematological, immunological, psychiatric and other systemic diseases that have been determined by researchers to be unsuitable for inclusion; 3) Individuals with a history of cardiovascular disease, including but not limited to syncope or family history, coronary heart disease (such as coronary angiography diagnosis of coronary heart disease, acute coronary syndrome, myocardial infarction, etc.), valvular heart disease, heart failure, non drug-induced bradycardia, frequent ventricular premature beats, ventricular tachycardia, etc; Or prolonged QTc interval in the past or other risk factors (hypokalemia, etc.) of torsade de pointes ventricular tachycardia, or family history of short QT syndrome, long QT syndrome, sudden death, drowning or sudden infant death syndrome of unknown causes in youth (<=40 years old), first-degree relatives (i.e. biological parents, brothers, sisters or children); 4) Individuals with a history of symptomatic head trauma; 5) Individuals with a history of frequent nausea or vomiting caused by any cause or medication; 6) Individuals who have special dietary requirements and cannot adhere to a uniform diet; 7) Individuals with a history of needle and blood dizziness or other factors (such as intolerance to venipuncture) causing difficulty in blood collection; 8) Any abnormality in hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody that has clinical significance; 9) Vital signs during screening (systolic blood pressure<90mmHg or>140mmHg, diastolic blood pressure<50mmHg or>90mmHg); Breathing<12 times/minute or>20 times/minute; Pulse rate<60 beats/minute or>100 beats/minute), physical examination, 12 lead electrocardiogram, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), chest radiograph or CT, abdominal ultrasound results. The researcher determines that the abnormality has clinical significance and is not suitable for inclusion; 10) During screening, transcutaneous oxygen saturation is less than 95%; 11) Abnormal electrocardiogram results during screening have clinical significance, such as QTc>=450ms in males and>=460ms in females [QTc calculated using Fridericia's formula: QTcF=QT/(RR ^ 0.33)]; PR interval>=200ms; QRS duration>=120ms; 12) Individuals whose blood potassium, magnesium, and calcium levels exceed the upper limit of the normal reference range or are below the lower limit of the normal reference range during screening; 13) Individuals with any history of drug abuse or positive urine drug screening during the screening period; 14) Individuals who have undergone major surgeries or surgeries that may significantly affect the in vivo process or safety evaluation of the investigational drug within the 6 months prior to screening; 15) Individuals who frequently consume alcohol within the first 6 months of screening, i.e. those who consume more than 14 units of alcohol per week (1 unit ≈ 360mL beer or 45mL of 40% alcohol strong liquor or 150mL wine) or cannot stop using any alcoholic products during the trial period, or whose breathalyzer test result at check-in is greater than 0.0mg/100mL; 16) Individuals who have smoked at least 5 cigarettes or an equivalent amount of tobacco products per day within the previous 3 months, or who cannot stop using any tobacco products during the trial period; 17) Screening individuals who have donated blood or experienced significant blood loss (>400mL) within the previous 3 months, received blood transfusions or used blood products, or plan to donate blood during or within 1 month after the trial period; 18) Screening for individuals who have consumed excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250mL) daily within the past 3 months; 19) Individuals who have participated in any clinical trial within the previous 3 months and have received investigational drugs or medical devices, or who plan to participate in other clinical trials during the trial period; 20) Screening individuals who have received vaccination within the previous 30 days or plan to receive vaccination during the trial period; 21) Screening for drugs that alter liver CYP2C9 and CYP3A4 enzyme activity, including strong inhibitors and inducers that affect liver metabolic enzymes or drugs that cause QT/QTc interval prolongation, during the 28 days prior to screening or during the trial period (specific drug information can be found in Appendix 3: Drugs known to inhibit or induce CYP liver enzyme activity and drugs that may prolong QT interval, etc.); 22) Those who have taken any prescription drugs, over-the-counter drugs, health supplements, vitamins, or traditional Chinese medicine within 14 days before check-in; 23)Within 7 days prior to check-in, have consumed special foods such as starfruit, grapefruit, grapefruit, dragon fruit, mango, or related products (such as beverages containing grapefruit); 24) Those who consume chocolate, any food containing caffeine, or foods rich in xanthine within 48 hours before check-in; 25) Female trial participants who are breastfeeding or have positive pregnancy results; 26) Individuals who experience acute illness from the screening stage to randomization; 27) Researchers believe that it should not be included.

研究实施时间：

Study execute time：

从 From 2025-11-14 00:00:00至 To 2027-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-12-29 00:00:00 至 To 2026-02-28 00:00:00  

干预措施：

Interventions：

组别：

组1：3.5mg（含3例安慰剂）

样本量：

12

Group：

Group 1:3.5mg (including 3 placebo cases)

Sample size：

干预措施：

给药当天在空腹条件下单次静脉给药(YZJ-4729 酒石酸盐注射液（3.5mg）/安慰剂)，输注时间 10min（±1min）。给药前 2 小时到开始给药后 2小时内禁水。在给药后继续空腹 4 小时。

干预措施代码：

Intervention：

On the day of administration, a single intravenous dose of YZJ-4729 Tartrate Injection (3.5 mg) or placebo was given under fasting conditions, with an infusion duration of 10 minutes (± 1 minute).No water intake was allowed from 2 hours before administration to 2 hours after the start of administration. Fasting was continued for another 4 hours after drug administration.

Intervention code：

组别：

组2：4.5mg（含3例安慰剂）

样本量：

12

Group：

Group 2: 4.5mg (including 3 placebo cases)

Sample size：

干预措施：

给药当天在空腹条件下单次静脉给药(YZJ-4729 酒石酸盐注射液（4.5mg）/安慰剂)，输注时间 10min（±1min）。给药前 2 小时到开始给药后 2小时内禁水。在给药后继续空腹 4 小时。

干预措施代码：

Intervention：

OOn the day of administration, a single intravenous dose of YZJ-4729 Tartrate Injection (4.5 mg) or placebo was given under fasting conditions, with an infusion duration of 10 minutes (± 1 minute).No water intake was allowed from 2 hours before administration to 2 hours after the start of administration. Fasting was continued for another 4 hours after drug administration.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China 

Province：

Human 

City：

 

单位(医院)：

中南大学湘雅三医院 

单位级别：

三甲 

Institution
hospital：

The Third Xiangya Hospital of Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

12-导联心电图指标

指标类型：

主要指标

Outcome：

12-lead electrocardiogram indicators

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生命体征

指标类型：

主要指标

Outcome：

Vital signs

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药代动力学

指标类型：

次要指标

Outcome：

Pharmacokinetic Indicators

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

 使用后保存  

说明

Fate of sample：

Preservation 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）：

每个剂量组分别随机，采用区组随机化方法，试验药和安慰剂组间比例 3:1，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（试验药或安慰剂）。

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

Each dose group was randomly assigned using a block randomization method, with a ratio of 3:1 between the investigational drug and placebo groups. The statistical unit generated a random number and its corresponding group (investigational drug or placebo) 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

Blinding：

Double-blind

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：

数据采集：由研究者或其授权的CRC通过独立的账号进入数据管理系统，进行数据采集。 数据管理：数据管理员根据方案设计eCRF，eCRF中包含除外部数据外方案中规定的全部数据点。由EDC系统直接导出eCRF（PDF格式）。

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

Data collection: Researchers or their authorized clinical research coordinators (CRCs) access the data management system through independent accounts to conduct data collection. Data management: Data managers design the electronic case report forms (eCRF) according to the protocol. The eCRF contains all the data points specified in the protocol except for external data. The eCRF (in PDF format) is directly exported from the Electronic Data Capture (EDC) system.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-12-26 08:27:40