ChiCTR2400080532 版本V1.0 版本创建时间2024/01/31 17:09:20 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：

ChiCTR2400080532 

最近更新日期：

Date of Last Refreshed on：

2024-01-31 17:09:16 

注册时间：

Date of Registration：

2024-01-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价单剂量奥美克松钠静脉注射给药在轻中度肾功能不全和健康受试者中的开放、平行对照的安全性和药代动力学研究

Public title：

An open, parallel controlled safety and pharmacokinetics study evaluating the intravenous administration of single dose Adamgammdex sodium in mild to moderate renal insufficiency and healthy subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价单剂量奥美克松钠静脉注射给药在轻中度肾功能不全和健康受试者中的开放、平行对照的安全性和药代动力学研究

Scientific title：

An open, parallel controlled safety and pharmacokinetics study evaluating the intravenous administration of single dose Adamgammdex sodium in mild to moderate renal insufficiency and 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：

胡惠兰 

研究负责人：

樊莲莲 

Applicant：

Hu Huilan 

Study leader：

Fan Lianlian 

申请注册联系人电话：

Applicant telephone：

+86 183 6880 7197

研究负责人电话：

Study leader's telephone：

+86 183 6880 7197

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：

huhuilan@adamerck.com

研究负责人电子邮件：

Study leader's E-mail：

dysyylunli@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：

杭州市余杭区金昌路2073号2-2幢

研究负责人通讯地址：

四川省德阳市旌阳区泰山北路173号

Applicant address：

Building 2-2, 2073 Jinchang Road, Yuhang District, Hangzhou

Study leader's address：

No. 173 Taishan North Road, Jingyang District, Deyang City, Sichuan Province

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：

杭州奥默医药股份有限公司

Applicant's institution：

Hangzhou Adamerck Pharmlabs Inc

研究负责人所在单位：

德阳市人民医院

Affiliation of the Leader：

Deyang People's 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：

2024-01-005-H01

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：

德阳市人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Deyang People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-01-19 00:00:00

伦理委员会联系人：

张标

Contact Name of the ethic committee：

Zhang Biao

伦理委员会联系地址：

德阳市旌阳区泰山北路173号

Contact Address of the ethic committee：

No. 173 Taishan North Road, Jingyang District, Deyang City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 838 231 2773

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：

德阳市人民医院

Primary sponsor：

Deyang People's Hospital

研究实施负责（组长）单位地址：

四川省德阳市旌阳区泰山北路173号

Primary sponsor's address：

No. 173 Taishan North Road, Jingyang District, Deyang City, Sichuan Province

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)：

杭州奥默医药股份有限公司

具体地址：

余杭区金昌路2073号2-2幢

Institution
hospital：

Hangzhou Adamerck Pharmlabs Inc

Address：

Building 2-2, 2073 Jinchang Road, Yuhang District

经费或物资来源：

申办方

Source(s) of funding：

Sponsor

Target disease：

Renal insufficiency

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

主要研究目的： 评价奥美克松钠静脉注射单次给药后，在不同程度肾功能不全和肾功能正常健康受试者中的药代动力学特征，评估不同程度肾功能不全对药物药代动力学的影响，为肾功能不全患者的临床用药提供依据。 次要研究目的： 评价奥美克松钠静脉注射单次给药后，在不同程度肾功能不全和肾功能正常健康受试者中的安全性。  

Objectives of Study：

Primary objectives: To evaluate the pharmacokinetic characteristics of adamgammadex sodium after single intravenous administration in healthy subjects with different degrees of renal insufficiency and normal renal function, and to evaluate the effects of different degrees of renal insufficiency on pharmacokinetics so as to provide evidence for clinical drug use for patients with renal insufficiency. Secondary objective: To evaluate the safety of adamgammdex sodium after a single intravenous administration in healthy subjects with different degrees of renal insufficiency and normal renal function.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

轻度、中度肾功能不全受试者必须符合以下所有标准才能进入本研究： (1) 签署知情同意书当日年龄18至75岁（包括两端值），男女均可； (2) 体重指数（BMI）在18.0 kg/m2~30.0 kg/m2范围内（包括两端值），且男性体重≥50.0kg，女性体重≥45.0kg； (3) 以肾小球滤过率（eGFR）划分不同程度肾功能不全受试者（eGFR参考附录二CKD-EPI 2021 公式计算）： 轻度肾功能不全受试者：60≤eGFR＜90 mL/min/1.73m2； 中度肾功能不全受试者：30≤eGFR＜60 mL/min/1.73m2； (4) 针对肾功能不全的受试者，应为患有慢性肾脏病（chronic kidney disease，CKD），存在任何肾损伤指标异常（包括血液或尿液成分异常、肾脏病理学或影像学检查等）持续3个月以上者；且肾功能稳定的个体（定义为给药前三个月内两次eGFR 检测在同一CKD分期内，两次检测需间隔至少3天）； (5) 有生育能力的受试者（男性或女性）必须同意在试验期间和末次给药后3个月内采用一种经医学认可的避孕措施（详见附录一），并且在试验期间及试验结束后3个月内无捐献精子/卵子计划； (6) 试验前已经详细了解试验性质、意义、可能的获益，可能带来的不便和潜在的危险，并自愿参加本次临床试验，能与研究者良好沟通，遵从整个研究的要求，且签署了书面的知情同意书。 肾功能正常健康受试者必须符合以下所有标准才能进入本研究： (1) 签署知情同意书当日年龄18至75岁（包括两端值），男女均可； (2) 体重指数（BMI）在18.0 kg/m2~30.0 kg/m2范围内（包括两端值），且男性体重≥50.0kg，女性体重≥45.0kg； (3) 肾小球滤过率（eGFR）≥90 mL/min/1.73m2（eGFR参考附录二CKD-EPI 2021公式计算）； (4) 有生育能力的受试者（男性或女性）必须同意在试验期间和末次给药后3个月内采用一种经医学认可的避孕措施（详见附录一），并且在试验期间及试验结束后3个月内无捐献精子/卵子计划； (5) 试验前已经详细了解试验性质、意义、可能的获益，可能带来的不便和潜在的危险，并自愿参加本次临床试验，能与研究者良好沟通，遵从整个研究的要求，且签署了书面的知情同意书。

Inclusion criteria

Participants with mild and moderate renal insufficiency must meet all of the following criteria to enter the study: (1) Aged between 18 and 75 on the date of signing the informed consent; (2) Body mass index (BMI) beatween 18.0 kg/m2 and 30.0 kg/m2, and weight ≥50.0kg for male, weight ≥45.0kg for female; (3) Subjects with renal insufficiency of different degrees were divided according to glomerular filtration rate (eGFR) (eGFR was calculated by referring to CKD-EPI 2021 in Appendix II) : Subjects with mild renal insufficiency: 60≤eGFR < 90 mL/min/1.73m2; Subjects with moderate renal insufficiency: 30≤eGFR < 60 mL/min/1.73m2; (4) Subjects with renal insufficiency are those who have chronic kidney disease (CKD) and have any abnormal indicators of kidney injury (including abnormal blood or urine components, renal pathology or imaging examination, etc.) lasting for more than 3 months with stable renal function (defined as two eGFR tests within the same CKD stage within three months before administration of drug, and the interval between the two tests should be at least 3 days); (5) Fertile subjects (male or female) should agree to use a medically approved contraceptive method during the trial period and within 3 months after the final dosing (see Appendix I), and have no plans to donate sperm/eggs during the trial period and within 3 months after the trial; (6) Subjects have a detailed understanding of the nature, significance, possible benefits and inconvenience and potential dangers of the trial before the trial, and is voluntary to participate in this clinical trial, is able to communicate well with the investigator, comply with the requirements of the entire study, and have signed a written informed consent. Healthy subjects with normal renal function must meet all of the following criteria to enter this study: (1) Aged between 18 and 75 on the date of signing the informed consent; (2) Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2, and weight ≥50.0kg for male, weight ≥45.0kg for female ; (3) Glomerular filtration rate (eGFR) ≥90 mL/min/1.73m2 (eGFR was calculated by referring to CKD-EPI 2021 formula in Appendix II); (4) Fertile subjects (male or female) should agree to use a medically approved contraceptive method during the trial period and within 3 months after the final dosing (see Appendix I), and have no plans to donate sperm/eggs during the trial period and within 3 months after the trial; (5) Subjects have a detailed understanding of the nature, significance, possible benefits and inconvenience and potential dangers of the trial before the trial, and is voluntary to participate in this clinical trial, is able to communicate well with the investigator, comply with the requirements of the entire study, and have signed a written informed consent.

排除标准：

轻度、中度肾功能不全受试者若符合下列标准中的任意一条，将不能进入本研究： 1) 曾经接受肾移植和/或研究期间需要肾透析治疗者； 2) 尿失禁或无尿者（24小时尿量＜100mL）； 3) 除致肾功能不全的疾病本身外，受试者存在可能影响药物吸收、分布、代谢或排泄的疾病或手术史（例如：炎性肠病、胃溃疡、消化道出血、胃肠道手术、胰腺炎、胃出口梗阻等），或预期试验期间可能有手术，或有心血管、呼吸、消化、内分泌、血液淋巴、免疫系统、恶性肿瘤、精神/神经系统严重疾病或病史，或经研究者判定认为可能影响试验结果的疾病或情况者； 4) 除判断为肾功能不全诊断的疾病导致的实验室检查、体格检查、生命体征、12-导联心电图、胸部低剂量CT、腹部B超检查异常外，存在其它结果异常有临床意义且研究者认为将影响试验结果者，如丙氨酸氨基转移酶（ALT）＞2×正常值上限（ULN）和/或门冬氨酸氨基转移酶（AST）＞2×ULN和/或总胆红素（TBIL）＞1.5×ULN；血红蛋白（Hb）＜90 g/L；12-导联心电图检查存在II-III度房室传导阻滞或QTcF间期延长（男性≥470 ms，女性≥480 ms）（按附录二Fridericia’s公式校正）； 5) 具有遗传性出血或凝血疾病或非创伤性出血病史（需要治疗的出血）、血栓栓塞病史；目前存在任何能够引起出血风险的疾病，包括凝血疾病、血小板减少者（血小板计数＜75×10^9/L；凝血酶原国际标准化比值＞1.5）； 6) 血压控制不佳者（收缩压≥160 mmHg和/或舒张压≥100 mmHg）； 7) 经研究者判断从筛选至研究结束受试者所患肾脏疾病不稳定，肾小球滤过率可能会出现显著改变者； 8) 筛选前1个月内，对肾功能不全和/或其他合并疾病治疗，无稳定的治疗方案者（如用药种类、剂量或服药频率等）； 9) 过敏体质者（如已知对两种或以上药物、食物如牛奶和花粉过敏），特别是对奥美克松钠及其辅料（包括舒更葡糖钠等环糊精类药物）过敏者； 10) 筛选时人类免疫缺陷病毒抗原+抗体（HIVAg+Ab）阳性，或活动性梅毒者； 11) 筛选时活动性乙型病毒性肝炎者（定义为HBsAg阳性且HBV DNA≥2000cps或500IU/ml），或活动性丙型病毒性肝炎者（定义为抗HCV抗体阳性且HCV RNA阳性）； 12) 筛选前3个月内接受过重大手术或者手术切口没有完全愈合，经研究者判定认为不宜参加者； 13) 在筛选前3个月内使用研究禁用药物，包括夫地西酸、枸橼酸托瑞米芬、枸橼酸他莫昔芬、枸橼酸氯米芬、黄体酮、炔诺酮、睾酮、泼尼松等其他甾体激素类药物，以及罗库溴铵、维库溴铵、泮库溴铵等（参考方案5.8.1）； 14) 筛选前3个月内参加临床试验并且使用过研究药物者； 15) 筛选前3个月内有献血行为者，6个月内献血或其他原因失血总和达到或超过400 mL者（女性生理期失血除外），或计划在研究期间或研究结束后1周内献血或血液成份者； 16) 筛选前3个月内接种或暴露于其它灭活疫苗或减毒活疫苗者；或计划在研究期间接种灭活疫苗或减毒活疫苗者； 17) 筛选前3个月内平均每日吸烟大于5支者，或在试验期间不能戒烟者； 18) 筛选前3个月内每周饮用大于14个单位的酒精（1单位=360mL啤酒或45mL酒精量为40%的烈酒或150mL葡萄酒），或试验期间不能戒酒，或筛选期酒精呼气测试阳性者； 19) 有药物滥用史者，或筛选期药物滥用筛查阳性者； 20) 筛选前3个月内每天饮用过量茶、咖啡、葡萄柚/葡萄柚汁和/或含咖啡因的饮料（平均每天8杯以上，每杯200 mL）者，或在试验期间受试者拒绝停用任何可能影响药物代谢的食品及饮料，包括巧克力、茶、咖啡、可乐、富含黄嘌呤成分的食物（如沙丁鱼、动物肝脏等）、葡萄柚、葡萄柚产品、火龙果、芒果、柚子、橘子、杨桃、番石榴等； 21) 筛选及给药前72h内剧烈运动或大量摄入蛋白质或肉类食品等其他影响血肌酐检测或药物吸收、分布、代谢、排泄因素者； 22) 不能耐受静脉穿刺，或有晕针晕血史者； 23) 对饮食有特殊要求或乳糖不耐受，不能接受统一饮食者； 24) 筛选前14天内，女性受试者与伴侣发生非保护性性行为； 25) 妊娠或哺乳期女性，或育龄期女性受试者筛选期妊娠检查阳性者； 26) 根据研究者的判断，有其他不适宜入组情况者。 肾功能正常健康受试者若符合下列标准中的任一条，则不能参加本研究： 1) 既往有肾功能损害病史，或筛选时体格检查及实验室检查提示存在或可能存在肾功能损害者； 2) 受试者存在可能影响药物吸收、分布、代谢或排泄的疾病或手术史（例如：炎性肠病、胃溃疡、消化道出血、胃肠道手术、胰腺炎、胃出口梗阻等），或预期试验期间可能有手术，或有心血管、呼吸、消化、内分泌、血液淋巴、免疫系统、恶性肿瘤、精神/神经系统严重疾病或病史，或经研究者判定认为可能影响试验结果的疾病或情况者； 3) 筛选期实验室检查、体格检查、生命体征、12-导联心电图、胸部低剂量CT、腹部B超检查结果异常有临床意义且研究者认为将影响试验结果者；12-导联心电图检查存在II-III度房室传导阻滞或QTcF间期延长（男性≥470ms，女性≥480ms）（按Fridericia’s公式校正）； 4) 过敏体质者（如已知对两种或以上药物、食物如牛奶和花粉过敏），特别是对奥美克松钠及其辅料（包括舒更葡糖钠等环糊精类药物）过敏者； 5) 在给药前14天内使用过任何药物（包括处方药、非处方药、中草药制剂及方剂）或保健品者； 6) 在筛选前3个月内使用研究禁用药物，包括夫地西酸、枸橼酸托瑞米芬、枸橼酸他莫昔芬、枸橼酸氯米芬、黄体酮、炔诺酮、睾酮、泼尼松等其他甾体激素类药物，以及罗库溴铵、维库溴铵、泮库溴铵等（参考方案5.8.1）； 7) 筛选时乙型肝炎表面抗原（HBsAg）、丙型肝炎病毒抗体（HCV-Ab）、人类免疫缺陷病毒抗原+抗体（HIVAg+Ab）检查有一项或一项以上阳性者或活动性梅毒者； 8) 筛选前3个月内接受过重大手术或者手术切口没有完全愈合，经研究者判定认为不宜参加者； 9) 筛选前3个月内参加临床试验并且使用过研究药物者； 10) 筛选前3个月内有献血行为者，6个月内献血或其他原因失血总和达到或超过400 mL者（女性生理期失血除外），或计划在研究期间或研究结束后1周内献血或血液成份者； 11) 筛选前3个月内接种或暴露于其它灭活疫苗或减毒活疫苗者；或计划在研究期间接种灭活疫苗或减毒活疫苗者； 12) 筛选前3个月内平均每日吸烟大于5支者，或在试验期间不能戒烟者； 13) 筛选前3个月内每周饮用大于14个单位的酒精（1单位=360mL啤酒或45mL酒精量为40%的烈酒或150mL葡萄酒），或试验期间不能戒酒，或筛选期酒精呼气测试阳性者； 14) 有药物滥用史者，或筛选期药物滥用筛查阳性者； 15) 筛选前3个月内每天饮用过量茶、咖啡、葡萄柚/葡萄柚汁和/或含咖啡因的饮料（平均每天8杯以上，每杯200 mL）者，或在试验期间受试者拒绝停用任何可能影响药物代谢的食品及饮料，包括巧克力、茶、咖啡、可乐、富含黄嘌呤成分的食物（如沙丁鱼、动物肝脏等）、葡萄柚、葡萄柚产品、火龙果、芒果、柚子、橘子、杨桃、番石榴等； 16) 筛选及给药前72h内剧烈运动或大量摄入蛋白质或肉类食品等其他影响血肌酐检测或药物吸收、分布、代谢、排泄因素者； 17) 不能耐受静脉穿刺，或有晕针晕血史者； 18) 对饮食有特殊要求或乳糖不耐受，不能接受统一饮食者； 19) 筛选前14天内，女性受试者与伴侣发生非保护性性行为； 20) 妊娠或哺乳期女性，或育龄期女性受试者筛选期妊娠检查阳性者； 21) 根据研究者的判断，有其他不适宜入组情况者。

Exclusion criteria：

Subjects with mild or moderate renal insufficiency will not be admitted to the study if they meet any of the following criteria: 1) Those who have previously received a kidney transplant and/or required kidney dialysis during the study period; 2) Subjects with incontinence or no urine (24-hour urine volume < 100mL); 3) In addition to renal insufficiency, subjects have a medical condition or surgical history that may affect drug absorption, distribution, metabolism, or excretion (e.g. inflammatory bowel disease, gastric ulcer, gastrointestinal bleeding, gastrointestinal surgery, pancreatitis, gastric exit obstruction, etc.), or suspected to have surgery or a history of cardiovascular, respiratory, digestive, endocrine, hemolymph, immune system, malignancy, psychiatric/nervous system diseases or conditions during the trial or other disease or conditions determined by the investigator to be likely to affect the results of the trial; 4) Subjects who have other abnormalities in the results that are clinically significant and that the investigator believes will affect the outcome of the trial such as alanine aminotransferase (ALT) > 2× upper limit of normal (ULN) value and/or aspartate aminotransferase (AST) > 2×ULN and/or total bilirubin (TBIL) > 1.5×ULN; hemoglobin (Hb) < 90 g/L; degree II-III atrioventricular block or prolonged QTcF interval (male ≥470 ms, female ≥480 ms for 12-lead electrocardiographic examination (corrected according to Fridericia's formula in Appendix II), in addition to abnormalities in laboratory examination, physical examination, vital signs, 12-lead electrocardiogram, chest low-dose CT, and abdominal B-ultrasound due to renal insufficiency; 5) Subjects have a history of hereditary bleeding or clotting disorders or non-traumatic bleeding (bleeding requiring treatment), thromboembolism or have any diseases currently that can cause bleeding risk, including clotting disorders, thrombocytopenia (platelet count < 75×10^9/L; prothrombin international normalized ratio > 1.5); 6) Subjects have poor blood pressure control (systolic ≥160 mmHg and/or diastolic ≥100 mmHg); 7) Subjects who were judged by the investigators to have unstable kidney disease and are likely to have significant changes in glomerular filtration rate from screening to the end of the study; 8) Patients who have no stable treatment plan (such as type, dosage or frequency of medication) for renal insufficiency and/or other concomitant diseases within 1 month before screening; 9) Subjects who are known to be allergic to two or more drugs, foods such as milk and pollen, especially those who are allergic to adamgammadex sodium or its excipients (including cyclodextrins such as sugammadex sodium); 10) Subject who are positive in human immunodeficiency virus antigen + antibody (HIVAg+Ab) or active syphilis tests during screening; 11) Subjects with active viral hepatitis B (defined as HBsAg positive with HBV DNA≥2000cps or 500IU/ml) or active viral hepatitis C (defined as anti-HCV antibody positive with HCV RNA positive) during screening; 12) Subjects who had undergone major surgery or the surgical incision had not completely healed within 3 months prior to screening and were deemed unsuitable for the trial by the investigator; 13) Subjects who have used prohibited drugs for this trial, including fusidic acid, toremifene citrate, tamoxifen citrate, Clomiphene citrate, progesterone, norethisterone, testosterone, prednisone and other steroid hormones, as well as rocuronium, vecuronium, pancuronium, etc., within 3 months prior to screening (reference protocol 5.8.1); 14) Subjects who participated in clinical trials and used investigational drugs within 3 months before screening; 15) Subjects who have donated blood within 3 months prior to screening, who have donated blood or lost blood for other reasons within 6 months reached or exceeded 400 mL(excluding menstrual blood loss for women), or who plan to donate blood or blood components during the study period or within 1 week after the study; 16) Subjects who have received or been exposed to other inactivated or live attenuated vaccines within 3 months prior to screening or plan to receive an inactivated or live attenuated vaccine during the study period; 17) Subjects who smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or were unable to quit smoking during the trial period; 18) Subjects who consumed more than 14 units of alcohol per week within 3 months prior to screening (1 unit =360mL beer or 45mL spirits with 40% alcohol or 150mL wine), or were unable to quit drinking during the test period, or had a positive alcohol breath test during the screening period; 19) Subjects who have a history of drug abuse, or those who are positive for drug abuse screening during the screening period; 20) Subjects who have excessive consumption of tea, coffee, grapefruit/grapefruit juice and/or caffeinated beverages (more than 8 cups per day, 200 mL per cup in average) within 3 months prior to screening, or refused to discontinue any food or beverage that may affect drug metabolism during the trial period, including chocolate, tea, coffee, cola, foods rich in xanthines (such as sardines, animal liver, etc.), grapefruit, grapefruit products, dragon fruit, mango, grapefruit, orange, star fruit, guava, etc.; 21) Subjects with intense excercise or large intake of protein or meat foods and other factors affecting blood creatinine detection or drug absorption, distribution, metabolism and excretion within 72h before screening and administration; 22) Subjects who can not tolerate venous puncture, or have a history of fainting needles and fainting blood; 23) Subjects who have special dietary requirements or lactose intolerance and cannot accept a unified diet; 24) Female subjects who had unprotected sex with their partners within 14 days prior to screening; 25) Pregnant or lactating women, or female subjects of childbearing age who have positive pregnancy tests during the screening period; 26) Subjects who have other conditions that are not suitable for inclusion according to the judgment of the investigator Healthy subjects with normal renal function who meet any of the following criteria will not be eligible to participate in the study: 1) Patients with a history of renal impairment, or whoes physical examination and laboratory examination during screening indicate the existence or potential existence of renal impairment; 2) Subject who have a history of disease or surgery that may affect drug absorption, distribution, metabolism, or excretion such as inflammatory bowel disease, gastric ulcer, gastrointestinal bleeding, gastrointestinal surgery, pancreatitis, gastric exit obstruction, etc., or might have surgery during the trial period or have a history of serious cardiovascular, respiratory, digestive, endocrine, hemolymph, immune system, malignancy, psychiatric/nervous system diseases or other conditions determined by the investigator to affect the results of the trial; 3) Subject who have abnormal results in laboratory examination, physical examination, vital signs, 12-lead electrocardiogram, chest low-dose CT, or abdominal B-ultrasound during the screening period and which is clinically significant and considered by the investigators to affect the test results, or with degree II-III atrioventricular block or prolonged QTcF interval in 12-lead electrocardiographic examination (male ≥470ms, female ≥480ms) (corrected by Fridericia's formula); 4) Subjects who are known to be allergic to two or more drugs, foods such as milk and pollen, especially those who are allergic to adamgammadex sodium or its excipients (including cyclodextrins such as sugammadex sodium);; 5) Subject who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal preparations and formulas) or health products within 14 days before the administration of the drug; 6) Subjects who have used prohibited drugs for this trial, including fusidic acid, toremifene citrate, tamoxifen citrate, Clomiphene citrate, progesterone, norethisterone, testosterone, prednisone and other steroid hormones, as well as rocuronium, vecuronium, pancuronium, etc., within 3 months prior to screening (reference protocol 5.8.1); 7) Subjects who have one or more positive in hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antigen + antibody (HIVAg+Ab) examinations or active syphilis; 8) Subjects who had undergone major surgery or the surgical incision had not completely healed within 3 months prior to screening and were deemed unsuitable for the trial by the investigator; 9) Subjects who participated in clinical trials and used investigational drugs within 3 months before screening; 10) Subjects who have donated blood within 3 months prior to screening, or have donated blood or lost blood for other reasons within 6 months reached or exceeded 400mL in total (excluding menstrual blood loss for women), or plan to donate blood or blood components during the study period or within 1 week after the study; 11) Subjects who received or were exposed to other inactivated or live attenuated vaccines within 3 months prior to screening or plan to receive an inactivated or live attenuated vaccine during the study period; 12) Subjects who smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or were unable to quit smoking during the trial period; 13) Subjects who consumed more than 14 units of alcohol per week within 3 months prior to screening (1 unit =360mL beer or 45mL spirits with 40% alcohol or 150mL wine), or were unable to quit drinking during the test period, or tested positive in alcohol breath test during the screening period; 14) Subjects who have a history of drug abuse, or are positive in drug abuse screening during the screening period; 15) Subjects who have excessive consumption of tea, coffee, grapefruit/grapefruit juice and/or caffeinated beverages (averaging more than 8 cups per day, 200 mL per cup) within 3 months prior to screening, or refused to discontinue any food and beverage that may affect drug metabolism during the trial period, including chocolate, tea, coffee, cola, foods rich in xanthines (such as sardines, animal liver, etc.), grapefruit, grapefruit products, dragon fruit, mango, grapefruit, orange, star fruit, guava, etc.; 16) Subjects with intense excercise or large intake of protein or meat foods and other factors affecting blood creatinine detection or drug absorption, distribution, metabolism and excretion within 72h before screening and administration; 17) Subjects who can not tolerate venous puncture, or have a history of fainting needles and fainting blood; 18) Subjects who have special dietary requirements or lactose intolerance and cannot accept a unified diet; 19) Female subjects who had unprotected sex with their partners within 14 days prior to screening; 20) Pregnant or lactating women, or female subjects of childbearing age who have positive pregnancy tests during the screening period; 21) Subjects who have other conditions that are not suitable for inclusion according to the judgment of the investigator.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-01-31 00:00:00 至 To 2024-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组A：轻度肾功能不全

样本量：

8

Group：

Experiment Group A: Mild renal insufficiency

Sample size：

干预措施：

奥美克松钠8mg/kg

干预措施代码：

Intervention：

Adamgammadex 8mg/kg

Intervention code：

组别：

试验组B：中度肾功能不全

样本量：

8

Group：

Experiment Group B: Moderate renal insufficiency

Sample size：

干预措施：

奥美克松钠8mg/kg

干预措施代码：

Intervention：

Adamgammadex 8mg/kg

Intervention code：

组别：

试验组C：健康受试者

样本量：

8

Group：

Experiment Group C: Healthy subjects

Sample size：

干预措施：

奥美克松钠8mg/kg

干预措施代码：

Intervention：

Adamgammadex 8mg/kg

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China 

Province：

Sichuan 

City：

 

单位(医院)：

德阳市人民医院 

单位级别：

三甲 

Institution
hospital：

Deyang People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

PK指标：血浆中奥美克松钠主要药代动力学参数：Cmax、AUC0-t、AUC0-∞

指标类型：

主要指标

Outcome：

PK index: Main pharmacokinetic parameters of adamgammadex sodium in plasma are Cmax, AUC0-T, AUC0-∞

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

奥美克松钠的次要药代动力学参数：Tmax、t1/2、CL/F、Vz/F等

指标类型：

次要指标

Outcome：

Secondary pharmacokinetic parameters of adamgammadex sodium are Tmax, t1/2, CL/F, Vz/F, etc.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

奥美克松钠累积排泄率（Ae）、尿排泄分数（fe）和肾清除率（CLr）

指标类型：

次要指标

Outcome：

Cumulative excretion rate (Ae), urinary excretion fraction (fe) and renal clearance rate (CLr) of adamgammadex sodium

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安全性指标：安全性观察指标包括不良事件、生命体征、体格检查、实验室检查、12-导联心电图

指标类型：

次要指标

Outcome：

Safety measures: Safety measures include adverse events, vital signs, physical examination, laboratory examination and 12-lead electrocardiogram

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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)：

N/A

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

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）：

临床试验公共管理平台，http://www.medresman.org/

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

Clinical Trial Management Public Platform, http://www.medresman.org/

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：

本研究将采用电子数据采集（Electronic Data Capture，EDC）系统。数据将由研究中心人员直接录入到申办者认可的EDC系统中。录入到eCRF中的数据均需来自于研究中心的原始文件。适当的计算机编辑程序将被用来验证数据库的准确性。不一致的地方将通过EDC系统电子生成的质疑进行更正。在EDC系统下线前，每例受试者的eCRF和相关的质疑将以PDF的形式作为归档文件进行保存。

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

The Electronic Data Capture (EDC) system will be used in this study. The data will be entered directly into the sponsor approved EDC system by the research center personnel. Data entered into the eCRF must come from the original files of the research centers. Proper computer editing programs will be used to verify the accuracy of the database. Inconsistencies will be corrected through the challenge generated electronically by the EDC system. Each subject's eCRF and related challenges will be archived in PDF format before the offline of EDC system.

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：

  2024-01-31 17:09:16