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UBT251注射液在肾功能正常和肾功能不全受试者中的药代动力学研究
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注册号：

Registration number：

 ChiCTR2500110552 

最近更新日期：

Date of Last Refreshed on：

 2025-10-15 15:55:57 

注册时间：

Date of Registration：

 2025-10-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

UBT251注射液在肾功能正常和肾功能不全受试者中的药代动力学研究

Public title：

Pharmacokinetic Study of UBT251 Injection in Subjects with Normal Renal Function and Renal Insufficiency

注册题目简写：

English Acronym：

研究课题的正式科学名称：

UBT251注射液在肾功能正常和肾功能不全受试者中的药代动力学研究

Scientific title：

Pharmacokinetic Study of UBT251 Injection in Subjects with Normal Renal Function and Renal Insufficiency

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：

Guoping Yang 

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：

138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

Study leader's address：

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 of 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 of Central South 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：

 25157

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 of Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-18 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Xiaomin Wang

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：

138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, 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 of 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：

138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, 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)：

长沙

Country：

China

Province：

Human

City：

Changsha

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：

Third Xiangya Hospital, Central South University

Address：

138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

经费或物资来源：

联邦生物科技（珠海横琴）有限公司

Source(s) of funding：

The United Bio - Technology (Hengqin) Co

研究疾病：

肾功能不全  

Target disease：

Renal insufficiency

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：

 其它 

Study phase：

N/A

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

主要目的 在轻度、中度或重度肾功能不全受试者与肾功能正常受试者中，评价单次皮下注射UBT251注射液后的PK特征。 次要目的 1） 在轻度、中度或重度肾功能不全受试者与肾功能正常受试者中，评价单次皮下注射UBT251注射液后的安全性与耐受性（包括局部耐受性）。 2）评价肾功能正常和肾功能不全受试者单次皮下注射UBT251注射液的免疫原性特征。  

Objectives of Study：

Primary objective To evaluate the pharmacokinetic (PK) characteristics of UBT251 injection after a single subcutaneous injection in subjects with mild, moderate or severe renal insufficiency as well as those with normal renal function. Secondary objectives 1. To evaluate the safety and tolerability (including local tolerability) of UBT251 injection after a single subcutaneous injection in subjects with mild, moderate or severe renal insufficiency as well as those with normal renal function. 2. To evaluate the immunogenicity characteristics of UBT251 injection after a single subcutaneous injection in subjects with normal renal function and those with renal insufficiency.

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、已知对本试验用药或其制剂辅料过敏或对其它GLP-1受体激动剂类药物过敏，或既往有临床显著的多种或严重药物过敏史，或现症过敏疾患者或高敏体质； 2、有以下任何一种疾病的病史或证据，主要如下： a) 有甲状腺髓样癌（MTC）或2型多发性内分泌腺瘤病（MEN2）个人既往史或家族史（一级亲属内，即父母、子女或兄弟姐妹）； b) 筛选前5年内有恶性肿瘤病史（充分治疗的宫颈原位癌、基底细胞或鳞状上皮细胞皮肤癌、根治术后的局部前列腺癌、根治术后的乳腺导管原位癌除外）； c)有慢性/急性胰腺炎病史或胰腺损伤史、胰腺手术史； d)筛选前6个月内有急性胆囊炎、胆石症及严重的胆囊息肉病史且研究者评估参加试验可能增加受试者风险； e)合并有胃轻瘫或其他胃肠排空障碍相关疾病（如幽门梗阻、肠梗阻等）未控制的胃食管反流病、研究者评估为增加用药后风险的胃肠道疾病（如严重的活动性溃疡、炎症性肠病、胃食管反流病、急性胃肠炎、症状性慢性胃肠炎、功能性胃肠病、肠结核等）； f)曾有严重低血糖昏迷病史或筛选前2个月内任一周内出现3次或以上血糖<3.9 mmol/L（无论症状轻重）或筛选前2个月内每月出现1次或以上严重低血糖（血糖<3.0 mmol/L伴认知障碍或需他人协助）； g)有严重精神疾病史（包括但不限于自杀倾向或自杀未遂、精神分裂症、双向情感障碍症等）； 3、给药前2个月内使用过二肽基肽酶4（DPP-4）抑制剂、GLP-1、GCG、GIP和胰淀素靶点类药物（例如艾塞那肽、利拉鲁肽、利司那肽、司美格鲁肽、替尔泊肽、玛仕度肽等）；或既往使用上述药物不能耐受； 4、筛选时有符合下列标准的任何检查异常： a)肝功能损害，血清ALT或AST＞2×参考值范围上限（ULN），或血清总胆红素1.5×ULN； b)空腹甘油三酯＞＝5.6 mmol/L； c)国际标准化比值（INR）＞＝ 1.5×ULN； d)血清降钙素＞＝50 pg/mL（即50 ng/L）； e)血红蛋白<90 g/L； f)心电图检查心率＜55次/分或＞110次/分，或研究者评估异常有临床意义； g)受试者血压异常或控制不佳（定义为血压不在以下范围：90 mmHg＜＝收缩压＜＝160 mmHg或60 mmHg＜＝舒张压＜＝100 mmHg，或筛选前近一个月内存在降压药物调整）； h)筛选时乙型肝炎表面抗原检查阳性、或乙型肝炎病毒核心抗体阳性且乙型肝炎病毒脱氧核糖核酸超出参考值范围上限、丙型肝炎病毒抗体阳性且丙型肝炎病毒核糖核酸超出参考值范围上限、人免疫缺陷病毒抗体检查阳性或梅毒抗体检查阳性（需加做RPR滴度或TRUST检测，已治愈梅毒除外）； 5、给药前3个月内失血或献血超过400 mL，或接受过血液或血液成份输注；或计划在试验期间献血； 6、筛选前1个月内接种过减毒活疫苗或新冠疫苗，或计划在试验期间接种疫苗； 7、给药前28天内女性每周饮酒超过7杯或男性每周饮酒超过14杯（1杯=150 mL（5盎司）葡萄酒=360 mL（12盎司）啤酒=45 mL（1.5盎司）烈酒），或首次给药前48小时内服用过任何含酒精的制品，或基线访视时酒精呼气试验为阳性者，或试验期间不能禁酒； 8、每日吸烟超过10支或不能遵守研究中心吸烟相关规定； 9、给药前14天内饮用过量（一天8杯以上，1杯=200 mL）茶、咖啡或含咖啡因的饮料，或食用葡萄柚（西柚）、或富含黄嘌呤的食物或饮料，或给药前48小时内及试验期间不能停止食用富含黄嘌呤成分的食物或饮料（如巧克力、茶、咖啡及可乐等）、或葡萄柚（西柚）或柚子以及含葡萄柚或柚子成分的产品（西柚汁、柚子汁等）； 10、给药前1年有吸毒史或药物滥用史，或尿药筛查阳性； 11、不能耐受静脉穿刺者，有晕针或晕血史； 12、试验期间不能保持规律饮食和运动； 13、给药前3个月内参加过其它临床试验（仅参加筛选但未给药或非干预性研究除外）； 14、妊娠或哺乳期女性； 15、研究者认为受试者具有可能影响PK评估的其他情况、或有可能导致受试者不能完成本研究的情况、或参与研究可能给受试者带来明显风险、或其他不适合参加本研究的情况； 16、对于肾功能不全组（轻、中、重度肾功能不全）： a)患有梗阻性尿路疾病（如，泌尿系结石、腹腔占位性病变所致尿路梗阻等）或其他与实质肾功能障碍（如肾脏肿瘤等）和/或患有与肾脏疾病无关但会引起肾损害的疾病（如，肾动脉狭窄、急性药物损伤、严重感染、血容量不足、心力衰竭等）的肾损害；或研究者评估可能增加感染风险； b)接受过肾移植； c)既往有严重心血管、内分泌、神经等系统疾病，且研究者评估不适宜参加本临床试验，包括但不限于以下情形： i.筛选前6个月内发生动/静脉血栓事件，如脑血管意外（包括短暂性脑缺血发作、脑出血、脑梗塞[陈旧性腔隙性脑梗塞除外]）、深静脉血栓; ii.筛选前6个月内有心肌梗死病史或经皮冠状动脉介入治疗、冠状动脉搭桥术等手术史； iii.筛选前6个月内有心力衰竭病史，纽约心脏协会（NYHA）功能分级为Ⅲ级或Ⅳ级； iv.筛选前6个月内有糖尿病急性并发症病史（糖尿病酮症酸中毒、糖尿病乳酸酸中毒、高血糖高渗状态等）； v.筛选期血红蛋白A1c（HbA1c）＞10.5%； vi.既往或筛选时有严重视网膜、黄斑病变（包括但不限于增殖性视网膜病变、黄斑水肿、视网膜脱离等），经研究者判断需进一步紧急治疗； vii.筛选时存在严重糖尿病慢性并发症（包括但不限于严重的糖尿病神经病变、糖尿病足等）且研究者判定此并发症可能影响受试者依从性及安全性； d)筛选时治疗用药和/或其他合并疾病的治疗用药稳定服用不满1个月，或筛选前1个月内有新增用药（临时性或间断性使用的药物除外，例如1个月使用一次的促红细胞生成素，或者临时需要使用利尿剂等），或筛选前14天或5个半衰期（以较长者为准）内接受过任何已知会改变肾小管肌酐分泌的药物，例如西咪替丁、甲氧苄氨嘧啶或西苯唑啉等； e)筛选前3个月内使用类固醇糖皮质激素（以下情况除外：局部外用或关节腔内、鼻内和吸入型糖皮质激素；短期[＜＝7天] 系统使用糖皮质激素进行预防或治疗非自身免疫性的过敏性疾病）； 17、对于肾功能正常组： a)给药前14天或5个半衰期（以较长者为准）内使用过任何药物（包括非处方药、草药和膳食补充剂，例如可能影响研究结果的维生素和矿物质。但扑热息痛/对乙酰氨基酚除外）。

Exclusion criteria：

1. Known to be allergic to the investigational drug or its pharmaceutical excipients in this trial, or allergic to other GLP-1 receptor agonist drugs, or having a previous history of clinically significant multiple or severe drug allergies, or currently suffering from allergic diseases or having a hypersensitive constitution. 2. Having a history or evidence of any of the following diseases, mainly as follows: (1) Having a personal or family history (within first-degree relatives, i.e., parents, children or siblings) of medullary thyroid carcinoma (MT(3) or multiple endocrine neoplasia type 2 (MEN2); (2) Having a history of malignant tumors within 5 years before screening (except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery); (3) Having a history of chronic/acute pancreatitis or pancreatic injury or a history of pancreatic surgery; (4) Having a history of acute cholecystitis, cholelithiasis and severe gallbladder polyps within 6 months before screening, and the investigator assesses that participation in the trial may increase the risk to the subject; (5) Complicated with gastroparesis or other diseases related to gastrointestinal emptying disorders (such as pyloric obstruction, intestinal obstruction, etc.), uncontrolled gastroesophageal reflux disease, or having gastrointestinal diseases that the investigator assesses as increasing the risk after medication (such as severe active ulcers, inflammatory bowel disease, gastroesophageal reflux disease, acute gastroenteritis, symptomatic chronic gastroenteritis, functional gastrointestinal disorders, intestinal tuberculosis, etc.); (6) Having a history of severe hypoglycemic coma or having blood glucose < 3.9 mmol/L for 3 or more times in any week within 2 months before screening (regardless of the severity of symptoms), or having severe hypoglycemia (blood glucose < 3.0 mmol/L accompanied by cognitive impairment or requiring assistance from others) for 1 or more times per month within 2 months before screening; (7) Having a history of severe mental illness (including but not limited to suicidal tendencies or attempted suicide, schizophrenia, bipolar affective disorder, etc.); 3. Having used dipeptidyl peptidase 4 (DPP-4) inhibitors, GLP-1, GCG, GIP and amylin target drugs (such as exenatide, liraglutide, lixisenatide, semaglutide, tirzepatide, mazdutide, etc.) within 2 months before drug administration; or being unable to tolerate the above-mentioned drugs previously; 4. Having any abnormal examination results that meet the following criteria during screening: (1) Liver function impairment, with serum ALT or AST > 2 × the upper limit of the reference value range (ULN), or serum total bilirubin 1.5 × ULN; (2) Fasting triglycerides >= 5.6 mmol/L; (3) International normalized ratio (INR) >=1.5 × ULN; (4) Serum calcitonin >= 50 pg/mL (i.e., 50 ng/L); (5) Hemoglobin < 90 g/L; (6) Heart rate < 55 beats per minute or > 110 beats per minute in electrocardiogram examination, or the investigator assesses that the abnormality is clinically significant; (7) Subjects with abnormal blood pressure or poorly controlled blood pressure (defined as blood pressure not within the following range: 90 mmHg <= systolic blood pressure <= 160 mmHg or 60 mmHg <= diastolic blood pressure <=100 mmHg, or there has been an adjustment of antihypertensive drugs within the last month before screenin(7); (8) Positive for hepatitis B surface antigen during screening, or positive for hepatitis B core antibody and hepatitis B virus deoxyribonucleic acid exceeding the upper limit of the reference value range, positive for hepatitis C virus antibody and hepatitis C virus ribonucleic acid exceeding the upper limit of the reference value range, positive for human immunodeficiency virus antibody or positive for syphilis antibody (requiring additional RPR titer or TRUST testing, except for cured syphilis); 5. Having lost blood or donated blood exceeding 400 mL within 3 months before drug administration, or having received blood or blood component transfusions; or planning to donate blood during the trial period; 6. Having been vaccinated with live attenuated vaccines or COVID-19 vaccines within 1 month before screening, or planning to be vaccinated during the trial period; 7. Females drinking more than 7 drinks per week or males drinking more than 14 drinks per week (1 drink = 150 mL (5 ounces) of wine = 360 mL (12 ounces) of beer = 45 mL (1.5 ounces) of spirits) within 28 days before the first drug administration, or having taken any alcohol-containing products within 48 hours before the first drug administration, or having a positive alcohol breath test at the baseline visit, or being unable to abstain from alcohol during the trial period; 8. Smoking more than 10 cigarettes per day or being unable to comply with the smoking-related regulations of the research center; 9. Drinking excessive amounts (more than 8 cups per day, 1 cup = 200 mL) of tea, coffee or caffeinated beverages, or eating grapefruit (pomelo), or consuming foods or beverages rich in xanthine within 14 days before drug administration, or being unable to stop consuming foods or beverages rich in xanthine components (such as chocolate, tea, coffee and cola, etc.), or grapefruit (pomelo) or pomelo and products containing grapefruit or pomelo components (grapefruit juice, pomelo juice, etc.) within 48 hours before drug administration and during the trial period; 10. Having a history of drug abuse or drug misuse within 1 year before drug administration, or having a positive urine drug screening result; 11. Being unable to tolerate venipuncture, having a history of fainting during needle insertion or seeing blood; 12. Being unable to maintain a regular diet and exercise during the trial period; 13. Having participated in other clinical trials within 3 months before drug administration (except for only participating in screening but not receiving drug administration or non-interventional studies); 14. Pregnant or lactating women; 15. The investigator believes that the subject has other circumstances that may affect PK evaluation, or circumstances that may lead to the subject's inability to complete this study, or participation in the study may bring obvious risks to the subject, or other circumstances that are not suitable for participating in this study; 16. For the renal insufficiency group (mild, moderate, or severe renal insufficiency): (1) Suffering from obstructive uropathy (such as urinary calculi, urinary tract obstruction caused by abdominal space-occupying lesions, etc.) or other diseases related to parenchymal renal dysfunction (such as renal tumors, etc.) and/or having diseases that are not related to kidney diseases but can cause kidney damage (such as renal artery stenosis, acute drug injury, severe infection, hypovolemia, heart failure, etc.); or the investigator assesses that it may increase the risk of infection; (2) Having received a kidney transplant; (3) Having a previous history of severe diseases in the cardiovascular, endocrine, nervous and other systems, and the investigator assesses that it is not appropriate to participate in this clinical trial, including but not limited to the following situations: 1) Having experienced arterial/venous thromboembolic events within 6 months before screening, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction [except for old lacunar cerebral infarction]), deep vein thrombosis; 2) Having a history of myocardial infarction or a history of surgeries such as percutaneous coronary intervention, coronary artery bypass grafting within 6 months before screening; 3) Having a history of heart failure within 6 months before screening, with New York Heart Association (NYH(1) functional classification of grade III or IV; 4) Having a history of acute complications of diabetes within 6 months before screening (diabetic ketoacidosis, diabetic lactic acidosis, hyperglycemic hyperosmolar state, etc.); 5) Hemoglobin A1c (HbA1(3) > 10.5% during the screening period; 6) Having severe retinal or macular lesions (including but not limited to proliferative retinopathy, macular edema, retinal detachment, etc.) previously or during screening, and the investigator judges that further urgent treatment is required; 7) Having severe chronic complications of diabetes (including but not limited to severe diabetic neuropathy, diabetic foot, etc.) during screening and the investigator determines that this complication may affect the subject's compliance and safety; (4) Having been taking stable treatment medications for less than 1 month for the treatment of existing diseases and/or other comorbidities during screening, or having newly added medications within 1 month before screening (except for medications used temporarily or intermittently, such as erythropoietin used once a month, or diuretics needed temporarily, etc.), or having received any drugs known to change renal tubular creatinine secretion within 14 days or 5 half-lives (whichever is longer) before screening, such as cimetidine, trimethoprim or cifenline, etc.; (5) Having used steroid glucocorticoids within 3 months before screening (except for the following situations: topical or intra-articular, intranasal and inhaled glucocorticoids; short-term [<= 7 days] systemic use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases); 17. For the renal function normal group: Having used any drugs (including over-the-counter drugs, herbs and dietary supplements, such as vitamins and minerals that may affect the study results. However, paracetamol/acetaminophen is exclude(4) within 14 days or 5 half-lives (whichever is longer) before drug administration.

研究实施时间：

Study execute time：

从 From 2025-10-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-30 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

组1：轻、中度肾功能不全组

样本量：

 6

Group：

Group 1: Mild to Moderate Renal Insufficiency Group

Sample size：

干预措施：

受试者应于空腹条件下取卧位，皮下注射UBT251，经另一人核对药物编号和剂量后，由临床研究护士在各受试者腹部脐周约5 cm范围皮下注射并停留10秒，同时检查注射情况（如是否漏液等）及注射部位反应；整个试验过程中受试者应规律饮食、规律运动，且不得从事超出惯例的剧烈体力活动，避免长时间卧床。

干预措施代码：

Intervention：

Subjects should take the supine position under fasting conditions and receive a subcutaneous injection of UBT251. After another person has checked the drug number and dosage, the clinical research nurse will give a subcutaneous injection within a range of about 5 cm around the umbilicus of each subject's abdomen and keep the needle in place for 10 seconds. Meanwhile, the injection situation (such as whether there is leakage, etc.) and the reaction at the injection site should be checked. Throughout the entire test process, subjects should maintain a regular diet and regular exercise, and should not engage in strenuous physical activities beyond the usual level, and avoid staying in bed for a long time.

Intervention code：

组别：

组2：重度肾功能不全组

样本量：

 6

Group：

Group 2: Severe Renal Insufficiency Group

Sample size：

干预措施：

受试者应于空腹条件下取卧位，皮下注射UBT251，经另一人核对药物编号和剂量后，由临床研究护士在各受试者腹部脐周约5 cm范围皮下注射并停留10秒，同时检查注射情况（如是否漏液等）及注射部位反应；整个试验过程中受试者应规律饮食、规律运动，且不得从事超出惯例的剧烈体力活动，避免长时间卧床。

干预措施代码：

Intervention：

Subjects should take the supine position under fasting conditions and receive a subcutaneous injection of UBT251. After another person has checked the drug number and dosage, the clinical research nurse will give a subcutaneous injection within a range of about 5 cm around the umbilicus of each subject's abdomen and keep the needle in place for 10 seconds. Meanwhile, the injection situation (such as whether there is leakage, etc.) and the reaction at the injection site should be checked. Throughout the entire test process, subjects should maintain a regular diet and regular exercise, and should not engage in strenuous physical activities beyond the usual level, and avoid staying in bed for a long time.

Intervention code：

组别：

组3：肾功能正常组

样本量：

 12

Group：

Group 3: Normal Renal Function Group

Sample size：

干预措施：

受试者应于空腹条件下取卧位，皮下注射UBT251，经另一人核对药物编号和剂量后，由临床研究护士在各受试者腹部脐周约5 cm范围皮下注射并停留10秒，同时检查注射情况（如是否漏液等）及注射部位反应；整个试验过程中受试者应规律饮食、规律运动，且不得从事超出惯例的剧烈体力活动，避免长时间卧床。

干预措施代码：

Intervention：

Subjects should take the supine position under fasting conditions and receive a subcutaneous injection of UBT251. After another person has checked the drug number and dosage, the clinical research nurse will give a subcutaneous injection within a range of about 5 cm around the umbilicus of each subject's abdomen and keep the needle in place for 10 seconds. Meanwhile, the injection situation (such as whether there is leakage, etc.) and the reaction at the injection site should be checked. Throughout the entire test process, subjects should maintain a regular diet and regular exercise, and should not engage in strenuous physical activities beyond the usual level, and avoid staying in bed for a long time.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

 合肥 

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

 安徽医科大学第一附属医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Anhui Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

 苏州市 

Country：

China

Province：

Jiangsu Province

City：

Suzhou City

单位(医院)：

 核工业总医院（苏州大学附属第二医院） 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Soochow University(The General Hospital of Nuclear Industry)

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

 长沙 

Country：

China

Province：

Human

City：

Changsha

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三甲 

Institution
hospital：

Third Xiangya Hospital, Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血药浓度

指标类型：

主要指标

Outcome：

Blood concentration

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

免疫原性指标

指标类型：

次要指标

Outcome：

Immunogenicity indicators

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

12-导联心电图指标

指标类型：

次要指标

Outcome：

12-lead electrocardiogram indicators

Type：

Secondary 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

指标类型：

次要指标

Outcome：

Adverse Events

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 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:

公开/Public

盲法：

无

Blinding：

None

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

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）：

https://www.trialos.com.cn/login/

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

https://www.trialos.com.cn/login/

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：

有/Yes

注册人：

Name of Registration：

  2025-10-15 15:55:39
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