今天是:2019-07-21 星期日

单中心、随机、双盲、安慰剂对照评价注射用奥美克松钠在健康受试者中的安全性、耐受性和药代动力学特征的Ⅰ期临床试验
下载XML文档

注册号:

Registration number:

ChiCTR1900024437 

最近更新日期:

Date of Last Refreshed on:

2019-07-12 

注册时间:

Date of Registration:

2019-07-12 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

单中心、随机、双盲、安慰剂对照评价注射用奥美克松钠在健康受试者中的安全性、耐受性和药代动力学特征的Ⅰ期临床试验 

Public title:

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial Assessing the Safety, Tolerability, and Pharmacokinetic Profiles of Adamgammadex Sodium for Injection in Healthy Volunteers 

注册题目简写:

奥美克松钠I期临床研究 

English Acronym:

Phase I trial of adamgammadex 

研究课题的正式科学名称:

单中心、随机、双盲、安慰剂对照评价注射用奥美克松钠在健康受试者中的安全性、耐受性和药代动力学特征的Ⅰ期临床试验 

Scientific title:

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial Assessing the Safety, Tolerability, and Pharmacokinetic Profiles of Adamgammadex Sodium for Injection in Healthy Volunteers 

研究课题代号(代码):

Study subject ID:

Aom0498-CT01 

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:

余葆春 

研究负责人:

刘进,江盈盈 

Applicant:

Baochun Yu 

Study leader:

Jin Liu, Yingying Jiang 

申请注册联系人电话:

Applicant telephone:

+86 13655810271 

研究负责人电话:

Study leader's telephone:

+86 18980601539, 18980605978 

申请注册联系人传真 :

Applicant Fax:

0571-86504023 

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:

yubaochun@adamerck.com 

研究负责人电子邮件:

Study leader's E-mail:

6667207@qq.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.adamerck.net/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.cd120.com/ 

申请注册联系人通讯地址:

浙江省杭州市拱墅区祥园路39号7幢5楼 

研究负责人通讯地址:

成都市武侯区国学巷37号 

Applicant address:

Fifth Floor, Building 7, 39 Xiangyuan Road, Gongshu District, Hangzhou, Zhejiang 

Study leader's address:

37 Guoxue Lane, Chengdu, Sichuan 

申请注册联系人邮政编码:

Applicant postcode:

310015 

研究负责人邮政编码:

Study leader's postcode:

610041 

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. 

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:

2016年临床试验(西药)审108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:

四川大学华西医院临床试验伦理分委会 

Name of the ethic committee:

Clinical Trial Ethics Sub-committee of West China Hospital, Sichuan University  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-12-21 

伦理委员会联系人:

孙荣国/左泽锦/李娜 

Contact Name of the ethic committee:

Rongguo Sun /Zejin Zuo /Na Li 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号 老八教 四楼 412室 

Contact Address of the ethic committee:

Room 412, Fourth Floor, Old Teaching Building 8, 37 Guoxue Lane, Chengdu, Sichuan 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 028-85422654 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

huaxilunli@163.com 

研究实施负责(组长)单位:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan 

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:

拱墅区祥园路39号7幢5楼

Institution
hospital:

Hangzhou Adamerck Pharmlabs Inc.

Address:

Fifth Floor, Building 7, 39 Xiangyuan Road, Gongshu District

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

研究疾病:

肌松拮抗 

Target disease:

Reversal of Neuromuscular Blockade 

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:

研究目的:

主要目的: 1.评价注射用奥美克松钠在健康受试者中的安全性、耐受性; 次要目的: 1.评价注射用奥美克松钠在健康受试者中的药代动力学特征。 探索性目的: 1.探索单次注射奥美克松钠后的安全性与急性肾损伤敏感标志物中的肾脏损伤分子-1(KIM-1)、尿胱蛋白酶抑制剂C、尿液凝聚素、尿液三叶因子3、尿N-乙酰氨基葡萄糖苷酶的关系; 2.探索单次注射奥美克松钠后的安全性与血类胰蛋白酶的关系。 

Objectives of Study:

Primary Objective: 1.To assess the safety and tolerability of Adamgammadex Sodium for Injection in healthy subjects. Secondary Objective: 1.To assess the PK profiles of Adamgammadex Sodium for Injection in healthy subjects. Exploratory Objectives: 1.To explore the relationship between the safety and the sensitive urinary markers of acute kidney injury following a single IV dose of adamgammadex sodium, including Kidney Injury Molecule-1 (KIM-1), Cystatin C, Clusterin, Trefoil Factor 3 (TFF3), and N-acetyl-β-D-glucosaminidase (NAG); 2.To explore the relationship between the safety and serum tryptase following a single IV dose of adamgammadex sodium. 

药物成份或治疗方案详述:

试验用药品规格及批号 试验药物:注射用奥美克松钠(规格:0.2 g/瓶,粉针剂),批号170401。 注射用水:5 ml/支,批号20160723。 生理盐水:0.9% NaCl溶液(规格:100ml/袋),批号:1703142331。 给药方法 本研究给药方法为通过静脉通路推注,静脉通路的维持采用平衡液。作为注射用药物,在给药前应该肉眼检查有无颗粒物和变色。 各剂量组受试者需要3个注射器,一个为溶解粉针剂使用,规格为2 ml;一个为抽取小于1 ml体积的研究药物使用,规格为1 ml;另外一个为注射给药使用。 1)在0.5 mg/kg剂量组,根据受试者体重和其所处的剂量组计算所需要的贮备液的体积,不足1 ml的使用采用平衡液稀释体积为1 ml,安慰剂组直接抽取0.9% NaCl溶液1 ml; 2)在2 mg/kg至32 mg/kg剂量组,根据受试者体重和其所处的剂量组计算所需要的贮备液的体积,采用合适的注射器进行静脉推注; 3)本研究中所有的给药静脉推注时间统一约为1 ml/秒(误差±1秒); 4)给药后应使用平衡液冲洗注射器,保证所有药物均进入人体。 

Description for medicine or protocol of treatment in detail:

Strengths and Batch Numbers of IMPs: Investigational drug: Adamgammadex Sodium for Injection (0.2g/vial, injectable powder), batch number 170401. Water for injection: 5 mL/vial, batch number 20160723. Normal saline: 0.9% NaCl solution (strength: 100 mL/bag), batch number: 1703142331. Dosing Methods: The dosing method was intravenous bolus injection, and the venous access was maintained with equilibrium liquid. As an injectable drug, it should be visually examined for particles and discoloration pre-dose. Three syringes were required for drug preparation and dosing, one (2 mL) for the dissolved powder, one (1 mL) for the IMPs with a volume of less than 1 mL, and one for injection. 1) In the 0.5 mg/kg dose group, the required volumes of the stock solutions were calculated according to body weights and doses. When the volumes were less than 1 mL, the solutions were diluted to 1 mL with the equilibrium liquid. For the placebo group, 1 mL of 0.9% NaCl solution was directly drawn. 2) In the dose groups of 2 mg/kg to 32 mg/kg, the required volumes of the stock solutions were calculated according to body weights and doses, and appropriate syringes were used for intravenous injection. 3) All the intravenous bolus injection rate was approximately 1 mL/s (error±1s). 4) The syringe should be rinsed post-dose with the equilibrium liquid to ensure that the IMPs completely entered the blood circulation. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1 年龄18-40岁(含界值),男女不限; 2 体重指数(BMI=体重/身高2)在19-26 kg/m2之间(包括19 kg/m2和26 kg/m2),并且男性体重≥50kg且≤90kg,女性体重≥45kg且≤85kg; 3 经筛选期内病史调查、体格检查、生命体征、X线胸片和12导联心电图评估,未发现有临床意义的异常; 4 受试者筛选期内临床实验室检查结果正常,或检查结果异常无临床意义,包括血常规、尿液检查、血生化、血β2微球蛋白、血清病毒学(乙肝病毒、丙肝病毒、人免疫缺陷病毒)、梅毒、凝血功能检查; 5 同意遵循试验方案和访视计划,并签署知情同意书。 

Inclusion criteria

1 Aged 18-40 years (including thresholds), male or female; 2 Body mass index (BMI=weight/height2) is between 19-26 kg/m2 (including thresholds), and male body weight is >= 50 kg and <= 90 kg, female body weight is >=45 kg and <= 85 kg; 3 At screening, no clinically significant abnormality is found in medical history, physical examination, vital signs, chest X-ray, and 12-lead ECG; 4 At screening, the results of laboratory tests are normal or are abnormal NCS. The tests include blood routine, urinalysis, blood biochemistry, blood β2 microglobulin, serum virology (hepatitis B virus, hepatitis C virus, human immunodeficiency virus), syphilis, and coagulation function; 5 Agree to follow the study protocol and follow-up plan and sign the informed consent. 

排除标准:

凡有下列情况之一,不能入选本研究: 1 目前存在具有临床意义的消化系统、泌尿系统、心血管系统、血液系统、呼吸系统、神经精神系统、内分泌及代谢系统等疾病; 2 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[血小板计数<100×10^9 L]、凝血酶原国际标准化比值>1.5)); 3 在给药前7天内存在发热性疾病; 4 受试者存在任何原因引起的严重的全身性过敏史,或怀疑存在对环糊精的超敏反应史,或对多种药物的超敏反应史; 5 受试者被证实存在任何过敏反应(如,食物过敏、药物过敏、特异性过敏反应或哮喘发作等),并经研究者判断会影响其参与试验的合格性; 6 受试者既往使用过舒更葡糖钠; 7 心电图异常且由研究者判断具有临床意义,或校正的QTc间期(QTc采用Fridericia校正公式计算:QTc=QT/(RR^0.33))>430 ms(男性)或>450 ms(女性); 8 研究筛选期和入院时血压、心率异常(收缩压>140 mmHg或<90 mmHg、舒张压>90 mmHg或<60 mmHg;心率<60 bpm或>100 bpm); 9 研究筛选期和入院时患有急性或慢性感染性疾病且具有临床意义;或筛选期丙肝抗体(HCVAb)、人免疫缺陷病毒抗体(HIVAb)、乙肝表面抗原(HBsAg)、梅毒任一检测阳性者; 10 在签署知情同意书前3个月内,受试者服用夫西地酸、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; 11 在研究药物给药前14天内服用任何药物及保健品者;如果服用药物或保健品的5个半衰期大于14天,则排除研究给药前处于该药物或保健品5个半衰期内的受试者; 12 任何影响研究药物吸收或药代动力学参数的情况; 13 在签署知情同意书前3个月内有献血史,或在研究期间计划献血; 14 在签署知情同意书前3个月内作为受试者参加过任何药物或器械临床试验,或在研究期间计划同时参加其他临床试验; 15 受试者每天吸烟超过10支或相当量; 16 酗酒者或研究药物给药前48小时内饮用含酒精饮料; 17 不愿意在研究期间使用有效的避孕措施的男性受试者;怀孕或哺乳期妇女,具有潜在生育能力的妇女不能或不愿意在研究期间使用有效的避孕措施; 18 女性受试者月经期预计发生在整个研究期间; 19 存在药物滥用以及医学、心理学或社会条件可能干扰研究或对研究结果的评估产生影响的受试者; 20 任何不稳定的或可能危及受试者安全性及研究依从性的状况; 21 研究者认为不适合参加该研究的受试者。 

Exclusion criteria:

A subject shall not be included in this study if the subject: 1 has existing diseases of digestive system, urinary system, cardiovascular system, blood system, respiratory system, neuropsychiatric system, or endocrine and metabolic system with clinical significance; 2 has a history of genetic bleeding disorders, coagulopathy, non-traumatic bleeding (requiring treatment), thromboembolism, or any existing disease associated with the risk of bleeding (including coagulopathy, thrombocytopenia [platelet count < 100x10^9/L], and prothrombin international normalized ratio > 1.5); 3 has any febrile disease within seven days pre-dose; 4 has a history of severe systemic allergy caused by any reason, suspected hypersensitivity to cyclodextrin, or hypersensitivity to multiple drugs; 5 has any confirmed allergic reactions (e.g., food allergy, drug allergy, specific allergic reactions, or asthma attack) affecting his/her eligibility determined by the investigators; 6 has a medication history of sugammadex sodium; 7 Abnormal ECG with clinical significance determined by the investigators, or QTc (calculated by Fridericias correction formula: QTc= QT/(RR)^0.33) > 430 ms (male) or > 450 ms (female); 8 has abnormal blood pressure or heart rate (systolic blood pressure > 140 mmHg or < 90 mmHg, diastolic blood pressure > 90 mmHg or < 60 mmHg, or heart rate < 60 bpm or > 100 bpm) at screening or admission.); 9 has acute or chronic infectious diseases with clinical significance at screening or admission, or any positive test result of hepatitis C antibody (HCVAb), human immunodeficiency virus antibody (HIVAb), hepatitis B surface antigen (HBsAg), or syphilis at screening; 10 has a medication history of other steroid hormone drugs, e.g., fusidic acid, toremifene citrate, tamoxifen citrate, clomiphene citrate, progesterone, norethindrone, testosterone, and prednisone within three months prior to the signing of the informed consent; 11 has a history of taking any medicine or dietary supplement within 14 days pre-dose; is within five half-lives of any medicine or dietary supplement with a half-life longer than 14 days. 12 has any conditions affecting the drug absorption or PK parameters of the IMPs; 13 has a history of blood donation within three months prior to the signing of the informed consent, or blood donation plan during the study; 14 has participated in any other drug or device clinical trial within three months prior to the signing of the informed consent, or plans to participate in other clinical trials during the study; 15 smokes more than ten cigarettes or equivalent per day; 16 is an alcoholic or has drunk alcoholic beverages within 48 h pre-dose; 17 is a male unwilling to use effective contraceptives during the study; is pregnant or lactating, or a female with potential fertility unable or unwilling to use effective contraceptives during the study; 18 is expected to has menstruation during the study; 19 has drug abuse or medical, psychological, or social conditions that may interfere with the study or affect the assessment of the study results; 20 has any unstable situation or any other situation that may endanger the safety and study compliance; 21 is determined to be unfit for the study by the investigators. 

研究实施时间:

Study execute time:

From2016-12-21To 2019-01-29 

干预措施:

Interventions:

组别:

0.5 mg/kg、2 mg/kg、4 mg/kg、8 mg/kg、16 mg/kg、24 mg/kg、32 mg/kg

样本量:

14

Group:

0.5 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, 16 mg/kg, 24 mg/kg, 32 mg/kg

Sample size:

干预措施:

每组2名受试者接受0.9% NaCl溶液

干预措施代码:

Intervention:

Two subjects in each cohort received 0.9% NaCl solution.

Intervention code:

组别:

0.5 mg/kg

样本量:

2

Group:

0.5 mg/kg

Sample size:

干预措施:

2名受试者接受注射用奥美克松钠

干预措施代码:

Intervention:

Two subjects received Adamgammadex Sodium for Injection.

Intervention code:

组别:

2 mg/kg、4 mg/kg、8 mg/kg、16 mg/kg、24 mg/kg、32 mg/kg

样本量:

36

Group:

2 mg/kg, 4 mg/kg, 8 mg/kg, 16 mg/kg, 24 mg/kg, 32 mg/kg

Sample size:

干预措施:

每组6名受试者接受注射用奥美克松钠

干预措施代码:

Intervention:

Six subjects in each cohort received Adamgammadex Sodium for Injection.

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):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

Hematology

Type:

Primary indicator 

测量时间点:

筛选期、给药后4小时(±10分钟)、第2天、第4天(±1天)、第8天

测量方法:

Measure time point of outcome:

Screening, 4 h (±10 min), Day 2, Day 4 (±1 day), and Day 8 post-dose

Measure method:

指标中文名:

血生化

指标类型:

主要指标 

Outcome:

Biochemistry

Type:

Primary indicator 

测量时间点:

筛选期、给药后4小时(±10分钟)、第2天、第4天(±1天)、第8天

测量方法:

Measure time point of outcome:

Screening, 4 h (±10 min), Day 2, Day 4 (±1 day), and Day 8 post-dose

Measure method:

指标中文名:

血β2微球蛋白

指标类型:

主要指标 

Outcome:

blood β2 microglobulin

Type:

Primary indicator 

测量时间点:

筛选期、给药后4小时(±10分钟)、第2天、第4天(±1天)、第8天

测量方法:

Measure time point of outcome:

Screening, 4 h (±10 min), Day 2, Day 4 (±1 day), and Day 8 post-dose

Measure method:

指标中文名:

尿液检查

指标类型:

主要指标 

Outcome:

Urinalysis

Type:

Primary indicator 

测量时间点:

筛选期、给药后4-6小时、第2天、第4天(±1天)、第8天

测量方法:

Measure time point of outcome:

Screening, 4-6 h, Day 2, Day 4 (±1 day), and Day 8 post-dose

Measure method:

指标中文名:

凝血功能

指标类型:

主要指标 

Outcome:

Coagulation function

Type:

Primary indicator 

测量时间点:

给药前30分钟内、给药后3分钟(±15秒)、10分钟(±30秒)、25分钟(±1分钟)、40分钟(±5分钟)、1小时(±5分钟)、3小时(±10分钟)、第2天、第4天(±1天)及第8天

测量方法:

Measure time point of outcome:

30 min pre-dose, 3 min (±15s), 10 min (±30s), 25 min (±1 min), 40 min (±5 min), 1 h (±5 min), 3 h (±10 min), Day 2, Day 4 (±1 day), and Day 8 post-dose

Measure method:

指标中文名:

体格检查

指标类型:

主要指标 

Outcome:

Physical examination

Type:

Primary indicator 

测量时间点:

筛选期、给药后第2天、第4天(±1天)及第8天

测量方法:

Measure time point of outcome:

Screening, Day 2, Day 4 (±1 day), and Day 8 post-dose

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:

筛选期、第-1天、给药前、给药后2小时(±5分钟)、4小时(±10分钟),8小时(±20分钟)、12小时(±30分钟)、第2天、第4天(±1天)及第8天

测量方法:

Measure time point of outcome:

Screening, Day -1, pre-dose, 2 h (±5 min), 4 h (±10 min), 8 h (±20 min), 12 h (±30 min), Day 2, Day 4 (±1 day), and Day 8 post-dose

Measure method:

指标中文名:

心电图

指标类型:

主要指标 

Outcome:

ECGs

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血类胰蛋白酶

指标类型:

主要指标 

Outcome:

Serum tryptase

Type:

Primary indicator 

测量时间点:

筛选期、过敏反应发生后3小时

测量方法:

Measure time point of outcome:

Screening and 3 h after onset of allergic reactions

Measure method:

指标中文名:

KIM-1

指标类型:

附加指标 

Outcome:

KIM-1

Type:

Additional indicator 

测量时间点:

筛选期内、给药后2-4小时、给药后6-8小时、第2天、第4天(±1天)及第8天

测量方法:

Measure time point of outcome:

Screening, 2-4 h, 6-8 h, Day 2, Day 4 (±1 day), and Day 8 post-dose

Measure method:

指标中文名:

尿胱蛋白酶抑制剂C

指标类型:

附加指标 

Outcome:

Cystatin C

Type:

Additional indicator 

测量时间点:

筛选期内、给药后2-4小时、给药后6-8小时、第2天、第4天(±1天)及第8天

测量方法:

Measure time point of outcome:

Screening, 2-4 h, 6-8 h, Day 2, Day 4 (±1 day), and Day 8 post-dose

Measure method:

指标中文名:

尿液凝聚素

指标类型:

附加指标 

Outcome:

Clusterin

Type:

Additional indicator 

测量时间点:

筛选期内、给药后2-4小时、给药后6-8小时、第2天、第4天(±1天)及第8天

测量方法:

Measure time point of outcome:

Screening, 2-4 h, 6-8 h, Day 2, Day 4 (±1 day), and Day 8 post-dose

Measure method:

指标中文名:

尿液三叶因子3

指标类型:

附加指标 

Outcome:

TFF3

Type:

Additional indicator 

测量时间点:

筛选期内、给药后2-4小时、给药后6-8小时、第2天、第4天(±1天)及第8天

测量方法:

Measure time point of outcome:

Screening, 2-4 h, 6-8 h, Day 2, Day 4 (±1 day), and Day 8 post-dose

Measure method:

指标中文名:

尿N-乙酰氨基葡萄糖苷酶

指标类型:

附加指标 

Outcome:

NAG

Type:

Additional indicator 

测量时间点:

筛选期内、给药后2-4小时、给药后6-8小时、第2天、第4天(±1天)及第8天

测量方法:

Measure time point of outcome:

Screening, 2-4 h, 6-8 h, Day 2, Day 4 (±1 day), and Day 8 post-dose

Measure method:

指标中文名:

PK血

指标类型:

次要指标 

Outcome:

PK blood

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

PK尿

指标类型:

次要指标 

Outcome:

PK urine

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 40 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):

采用随机信封进行随机分组,进入试验组或安慰剂组。随机序列由昆拓信诚医药研发(北京)有限公司提供。按照男女比例1:1分层随机,即每个剂量组的安慰剂组和注射用奥美克松钠组的受试者男女比例均为1:1。对于因任何原因退出/撤出临床研究的已随机分组的受试者,无论是否已给予研究药物,将保留其随机分组编号。一旦随机号和药物编号确定,在整个临床期间将不会发生变化。如果受试者在研究过程中退出,该随机号不能再用,退出的受试者也不能再参加本试验。如果被分配到错误的随机号,一旦研究药物已经分发,则无需纠正。该受试者应继续使用该随机号和已分发的研究药物。同时对于该情况,应立即通知申办方。后续的受试者使用随机号码表中第一个未被使用的随机号码。在随机信封确定要分配给某一受试者时,由主要研究者或其授权的研究者拆启并在随机信封上署名、签署日期后保存。

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

Randomization envelopes were used for randomizing the subjects to the treatment group or the placebo group. Random sequence was provided by KunTuo Medical Research and Development (Beijing) Co., Ltd. Stratified randomization was conducted according to a male to female ratio of 1:1.

盲法:

本研究为安慰剂对照的双盲研究。在整个研究过程中,研究者、参与研究的受试者以及任何与试验分析或利益相关的人员均不知道受试者的给药种类,即保持为双盲状态。 由授权参与研究的药剂师按照研究要求配置单个剂量的研究药物。研究者拆开随机信封后将获得的药物编号以及该受试者的筛选号以书面形式发送给药剂师(处方或随机信息表),药剂师在给药当天进行药物的配制。药剂师不能将受试者给药的信息泄露给研究者或受试者,并对给药用注射器进行贴标。标签上应记录:研究编号、受试者姓名缩写、药物编号、有效期限、随机号、剂量、给药方式、配药人/核对人、日期、申办方名称。一旦研究完成,将空包装和剩余的研究药物回收贮藏,最后一并返还申办方。

Blinding:

This study was designed to be double-blind and placebo-controlled. During the study period, the investigators, the subjects participating in the study, and any analysis or interest-related personnel did not know the types of the IMPs given, i.e., a double-blind state. The single doses of the IMPs were prepared by the authorized pharmacist according to the requirements. After the envelopes were opened, the obtained drug numbers and the subjects' screening numbers were sent in writing to the pharmacist (prescription or randomization information table), who prepared the IMPs on the day of administration and labeled the syringes. The pharmacist should not disclose the information to the investigators or the subjects. The labels included the following information: the study number, subject initials, drug numbers, periods of validity, random numbers, doses, the dosing method, the pharmacist/verifier, dates, and the sponsor. After the completion of the study, empty packaging and remaining IMPs were retrieved to the sponsor.

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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:

本研究采用电子数据采集(EDC)系统,研究数据(除外药代动力学)由研究者或授权的研究中心工作人员输入到电子病例报告表(eCRF)中。参加的研究人员经过培训统一记录方式与判断标准。研究者在临床试验过程中如实、详细记录各项原始资料和填写病例报告表。临床试验中所有观察结果和发现都进行核实,以保证数据的可靠性,确保临床试验中各项结论来源于原始数据。在临床试验和数据处理阶段均有相应的数据管理措施。 在研究结束后召开盲态数据审核会议,由主要研究者、研究者、昆皓睿诚医药研发(北京)有限公司实验室、申办方、统计分析负责人、数据管理负责人、监查员共同确定数据集人群,随后由数据管理员对数据库进行锁定。

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

The electronic data acquisition (EDC) system was used in the study. Data (except PK data) were entered into the electronic case report forms (eCRF) by the investigators or authorized personnel. The participants were trained to keep a consistent record format and assessment criteria. The investigators truthfully and detailedly recorded all the original data and filled in the case report forms. All the observations and findings were verified to ensure the reliability of the data and that the conclusions were drawn from the original data. For the study period and data processing, there were corresponding data administration measures. After the end of the study, a blind data review meeting was held, and the database was locked by the data administrator after the data sets were determined by the principal investigators, the sub-investigators, Q Squared Solutions (Beijing) Co., Ltd., the sponsor, the statistician, the data administrator, and the CRA.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-07-12
返回列表