ChiCTR2400090812 版本V1.0 版本创建时间2024/10/14 09:43:24 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：

ChiCTR2400090812 

最近更新日期：

Date of Last Refreshed on：

2024-10-14 09:43:19 

注册时间：

Date of Registration：

2024-10-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

CK15软胶囊在健康受试者中单剂量及多剂量给药的安全性、药代动力学和药效动力学的补充研究

Public title：

Supplementary Study on the Safety, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Dose CK15 Soft Capsules in Healthy Subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

CK15软胶囊在健康受试者中单剂量及多剂量给药的安全性、药代动力学和药效动力学的补充研究

Scientific title：

Supplementary Study on the Safety, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Dose CK15 Soft Capsules in 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：

蔡芸 

研究负责人：

蔡芸 

Applicant：

Yun Cai 

Study leader：

Yun Cai 

申请注册联系人电话：

Applicant telephone：

+86 10 6693 7166

研究负责人电话：

Study leader's telephone：

+86 10 6693 7166

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：

caicai_hh@126.com

研究负责人电子邮件：

Study leader's E-mail：

caicai_hh@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：

北京市海淀区复兴路28号

研究负责人通讯地址：

北京市海淀区复兴路28号

Applicant address：

28 Fuxing Road, Haidian District, Beijing

Study leader's address：

28 Fuxing Road, Haidian District, Beijing

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：

中国人民解放军总医院

Applicant's institution：

Chinese PLA General Hospital

研究负责人所在单位：

中国人民解放军总医院

Affiliation of the Leader：

Chinese PLA General 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：

伦审第C2024-034-01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：

中国人民解放军总医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Chinese PLA General Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-09-12 00:00:00

伦理委员会联系人：

曹江

Contact Name of the ethic committee：

Jiang Cao

伦理委员会联系地址：

北京市海淀区复兴路28号

Contact Address of the ethic committee：

28 fuxing road, haidian district, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 6693 7166

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：

中国人民解放军总医院

Primary sponsor：

Chinese PLA General Hospital

研究实施负责（组长）单位地址：

北京市海淀区复兴路28号

Primary sponsor's address：

28 Fuxing Road, Haidian District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

欣凯医药化工中间体（上海）有限公司

具体地址：

上海市张江高科技园区李冰路67弄3号楼3层

Institution
hospital：

Cinckate Pharmaceutical Intermediates Co.Ltd

Address：

3rd Floor, Building 3, Lane 67, Libing Road, Zhangjiang Hi-Tech Park, Shanghai

经费或物资来源：

由申办方提供

Source(s) of funding：

Provide by sponsor

Target disease：

Stage 3, 4, and 5 chronic kidney disease secondary hyperparathyroidism

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：

1.评价CK15软胶囊在健康受试者中单剂量给药和多剂量给药的安全性及耐受性 2.进一步明确CK15软胶囊的安全剂量范围 3.评价CK15软胶囊在健康受试者中的药代动力学及药效动力学特征  

Objectives of Study：

1. Assess the safety and tolerability of single-dose and multiple-dose administrations of CK15 soft capsules in healthy subjects. 2. Further define the safe dosage range of CK15 soft capsules. 3. Evaluate the pharmacokinetic and pharmacodynamic characteristics of CK15 soft capsules 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：

1.年龄18～45岁健康志愿者（包括边界值），男女均可，健康状况由研究者根据病史、手术史以及全部生理检查，包括：生命体征、心电图和实验室检查结果，进行判断； 2.体重：男性体重大于50kg，女性体重大于45kg，受试者体重指数（BMI）在18~28kg/m2之间（包括边界值）； 3.受试者及其配偶同意整个研究期间（从筛选到试验结束后6个月）采取有效避孕措施（有效避孕措施包括：输卵管结扎术、输精管结扎术、禁欲、使用避孕套、宫内节育器）； 4.受试者必须在试验前对本研究知情同意，并自愿签署书面的知情同意书； 5.受试者能够与研究者做良好的沟通并能够依照研究规定完成研究。

Inclusion criteria

1. Healthy volunteers aged 18 to 45 years (inclusive), both males and females, with health status determined by the investigator based on medical and surgical history, and all physical examinations, including: vital signs, electrocardiogram, and laboratory test results; 2. Weight: males weighing more than 50 kg, females weighing more than 45 kg, with a body mass index (BMI) between 18 and 28 kg/m^2 (inclusive); 3. The subject and their spouse agree to use effective contraceptive measures throughout the study period (from screening to 6 months after the end of the trial) (effective contraceptive methods include: tubal ligation, vasectomy, abstinence, use of condoms, intrauterine devices); 4. The subject must provide informed consent for the study prior to trial initiation and voluntarily sign a written informed consent form; 5. The subject is able to communicate effectively with the investigator and is capable of completing the study in accordance with the stipulated protocol.

排除标准：

1.有任何临床严重疾病史或有循环系统、内分泌系统、神经系统疾病、血液系统、免疫系统、或精神疾病及代谢异常等病史者； 2.有严重过敏性疾患史或过敏体质者，或明确对本品或其制剂成分（中链甘油三酸酯、叔丁基-4-羟基茴香醚、二丁基羟基甲苯、甘油和胶囊用明胶）过敏者； 3.曾经患过影响药物吸收或代谢的胃肠道及肝、肾疾病者； 4.曾经患有慢性感染性疾病，例如结核病； 5.试验前4周内患过具有临床意义的疾病或接受过外科手术者； 6.实验室检查（血常规、尿常规、血液生化检查等）发现有临床意义异常者 a.血钙异常者（血钙 < 2.09 mmol/L或>2.54 mmol/L）； b.血磷异常者（血磷 <0.89 mmol/L或>1.6 mmol/L）； c.血iPTH异常者（血iPTH < 15 pg/mL 或>65 pg/mL）； 7.心电图、胸片具有临床意义的异常者或生命体征异常者（收缩压<90 mmHg或>140 mmHg，舒张压<50 mmHg或>90 mmHg；心率<50 bpm或>100 bpm）； 8.HIV检测阳性者，乙型肝炎表面抗原（HBsAg）检测阳性、梅毒螺旋体抗体（TP-Ab）检测阳性或丙型肝炎检测阳性者； 9.目前有大量饮酒（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]），或者研究期间不能禁烟禁酒者； 10.试验前3个月及试验期间服用毒品（如：大麻）或试验前一年及试验期间服用毒品（如：可卡因、苯环己哌啶等）者； 11.酒精呼气检查、药物尿筛检查呈阳性者（吗啡、甲基安非他明、氯胺酮、二亚甲基双氧安非他明、四氢大麻酚酸大麻药）； 12.不能遵守统一饮食者； 13.研究入组前7天内食用过特殊饮食(包括柚子和/或黄嘌呤饮食等)，或研究入组前48小时摄取了巧克力、任何含咖啡因食物或饮料，或研究入组前24小时内服用过任何含酒精的制品，或不愿意在研究期间停止摄入以上制品者； 14.吸烟（过去6个月内应用过尼古丁）和筛查时尼古丁检查阳性； 15.在试验前14天内服用过任何处方药物者； 16.在试验前3个月内参加了任何药物临床试验者； 17.试验前4周内献过血或计划在研究期间献血者； 18.筛选或给药前1天女性血HCG阳性； 19.可能因为其他原不能完成本研究或研究者认为不应纳入者；

Exclusion criteria：

1. Individuals with a history of any severe clinical disease or conditions affecting the circulatory, endocrine, nervous, hematopoietic, immune systems, or with psychiatric disorders and metabolic abnormalities; 2. Individuals with a history of severe allergic diseases or allergic constitution, or those who have a known allergy to this product or its excipient components (medium-chain triglycerides, butylated hydroxyanisole, butylated hydroxytoluene, glycerin, and gelatin for capsules); 3. Individuals with a history of gastrointestinal, hepatic, or renal diseases that could affect drug absorption or metabolism; 4. Individuals with a history of chronic infectious diseases, such as tuberculosis; 5. Individuals who have had a clinically significant illness or undergone surgical procedures within 4 weeks prior to the study; 6. Individuals with clinically significant abnormalities detected in laboratory tests (complete blood count, urinalysis, blood chemistry, etc.) a. Abnormal serum calcium levels (<2.09 mmol/L or >2.54 mmol/L); b. Abnormal serum phosphorus levels (<0.89 mmol/L or >1.6 mmol/L); c. Abnormal serum intact parathyroid hormone (iPTH) levels (<15 pg/mL or >65 pg/mL); 7. Individuals with clinically significant abnormalities in electrocardiogram (ECG), chest X-ray, or vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg; heart rate <50 beats per minute (bpm) or >100 bpm); 8. Individuals testing positive for HIV, hepatitis B surface antigen (HBsAg), Treponema pallidum antibodies (TP-Ab), or hepatitis C; 9. Individuals who currently consume large amounts of alcohol (i.e., more than 14 units of alcohol per week [1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine]), or those who cannot abstain from smoking or alcohol during the study period; 10. Individuals who have used drugs (e.g., marijuana) within 3 months prior to the study or during the study period, or have used drugs (e.g., cocaine, phencyclidine, etc.) within one year prior to the study or during the study period; 11. Individuals with positive results in alcohol breath tests or drug urine screening tests (morphine, methamphetamine, ketamine, MDMA, delta-9-tetrahydrocannabinol); 12. Individuals who cannot comply with a standardized diet; 13. Individuals who have consumed a special diet (including grapefruit and/or xanthine-rich diets, etc.) within 7 days prior to study enrollment, or who have ingested chocolate, any caffeine-containing food or beverage within 48 hours before study enrollment, or consumed any alcoholic products within 24 hours before study enrollment, or are unwilling to discontinue the intake of the above products during the study period; 14. Smokers (who have used nicotine within the past 6 months) and those with a positive nicotine test at screening; 15. Individuals who have taken any prescription medications within 14 days prior to the study; 16. Individuals who have participated in any drug clinical trials within the last 3 months; 17. Individuals who have donated blood within 4 weeks prior to the study or plan to donate blood during the study period; 18. Females with a positive serum human chorionic gonadotropin (hCG) test on the day of screening or the day before dosing; 19. Individuals who may be unable to complete the study due to other reasons, or whom the investigator deems should not be included.

研究实施时间：

Study execute time：

从 From 2024-10-14 00:00:00至 To 2025-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-10-14 00:00:00 至 To 2025-02-28 00:00:00  

干预措施：

Interventions：

组别：

单剂量爬坡（SAD）-4 μg

样本量：

8

Group：

single ascending dose (SAD) -4 μg

Sample size：

干预措施：

该组受试者按照双盲、随机分配口服试验药物4 μg或安慰剂，6名受试者口服试验药物，2名受试者口服安慰剂。每位受试者接受单剂量口服给药，给药后观察8天，完成安全性、药代动力学和药效动力学评价。由研究者判断安全性，再依次继续下一剂量组试验。

干预措施代码：

Intervention：

This group of subjects underwent double-blinding and were randomly assigned to receive either 4 μg of the oral test drug or a placebo. Six subjects received the oral test drug, while two subjects received the placebo. Each subject was administered a single oral dose and was observed for 8 days following administration to complete safety, pharmacokinetic, and pharmacodynamic evaluations. The investigator assessed safety before proceeding to the next dose group in sequence.

Intervention code：

组别：

单剂量爬坡（SAD）-8 μg

样本量：

8

Group：

single ascending dose (SAD) -8 μg

Sample size：

干预措施：

该组受试者按照双盲、随机分配口服试验药物8 μg或安慰剂，6名受试者口服试验药物，2名受试者口服安慰剂。每位受试者接受单剂量口服给药，给药后观察8天，完成安全性、药代动力学和药效动力学评价。由研究者判断安全性，再依次继续下一剂量组试验。

干预措施代码：

Intervention：

This group of subjects underwent double-blinding and were randomly assigned to receive either 8 μg of the oral test drug or a placebo. Six subjects received the oral test drug, while two subjects received the placebo. Each subject was administered a single oral dose and was observed for 8 days following administration to complete safety, pharmacokinetic, and pharmacodynamic evaluations. The investigator assessed safety before proceeding to the next dose group in sequence.

Intervention code：

组别：

单剂量爬坡（SAD）-12 μg

样本量：

8

Group：

single ascending dose (SAD) -12 μg

Sample size：

干预措施：

该组受试者按照双盲、随机分配口服试验药物12 μg或安慰剂，6名受试者口服试验药物，2名受试者口服安慰剂。每位受试者接受单剂量口服给药，给药后观察8天，完成安全性、药代动力学和药效动力学评价。由研究者判断安全性，再依次继续下一剂量组试验。

干预措施代码：

Intervention：

This group of subjects underwent double-blinding and were randomly assigned to receive either 12 μg of the oral test drug or a placebo. Six subjects received the oral test drug, while two subjects received the placebo. Each subject was administered a single oral dose and was observed for 8 days following administration to complete safety, pharmacokinetic, and pharmacodynamic evaluations. The investigator assessed safety before proceeding to the next dose group in sequence.

Intervention code：

组别：

单剂量爬坡（SAD）-16 μg

样本量：

8

Group：

single ascending dose (SAD) -16 μg

Sample size：

干预措施：

该组受试者按照双盲、随机分配口服试验药物16 μg或安慰剂，6名受试者口服试验药物，2名受试者口服安慰剂。每位受试者接受单剂量口服给药，给药后观察8天，完成安全性、药代动力学和药效动力学评价。由研究者判断安全性，再依次继续下一剂量组试验。

干预措施代码：

Intervention：

This group of subjects underwent double-blinding and were randomly assigned to receive either 16 μg of the oral test drug or a placebo. Six subjects received the oral test drug, while two subjects received the placebo. Each subject was administered a single oral dose and was observed for 8 days following administration to complete safety, pharmacokinetic, and pharmacodynamic evaluations. The investigator assessed safety before proceeding to the next dose group in sequence.

Intervention code：

组别：

单剂量爬坡（SAD）-20 μg

样本量：

8

Group：

single ascending dose (SAD) -20 μg

Sample size：

干预措施：

该组受试者按照双盲、随机分配口服试验药物20 μg或安慰剂，6名受试者口服试验药物，2名受试者口服安慰剂。每位受试者接受单剂量口服给药，给药后观察8天，完成安全性、药代动力学和药效动力学评价。由研究者判断安全性，再依次继续下一剂量组试验。

干预措施代码：

Intervention：

This group of subjects underwent double-blinding and were randomly assigned to receive either 20 μg of the oral test drug or a placebo. Six subjects received the oral test drug, while two subjects received the placebo. Each subject was administered a single oral dose and was observed for 8 days following administration to complete safety, pharmacokinetic, and pharmacodynamic evaluations. The investigator assessed safety before proceeding to the next dose group in sequence.

Intervention code：

组别：

单剂量爬坡（SAD）-24 μg

样本量：

8

Group：

single ascending dose (SAD) -24 μg

Sample size：

干预措施：

该组受试者按照双盲、随机分配口服试验药物24 μg或安慰剂，6名受试者口服试验药物，2名受试者口服安慰剂。每位受试者接受单剂量口服给药，给药后观察8天，完成安全性、药代动力学和药效动力学评价。由研究者判断安全性，再依次继续下一剂量组试验。

干预措施代码：

Intervention：

This group of subjects underwent double-blinding and were randomly assigned to receive either 24 μg of the oral test drug or a placebo. Six subjects received the oral test drug, while two subjects received the placebo. Each subject was administered a single oral dose and was observed for 8 days following administration to complete safety, pharmacokinetic, and pharmacodynamic evaluations. The investigator assessed safety before proceeding to the next dose group in sequence.

Intervention code：

组别：

多剂量爬坡（MAD）-12μg

样本量：

12

Group：

multiple ascending dose(MAD)-12μg

Sample size：

干预措施：

该组受试者按照双盲、随机分配口服试验药物12μg或安慰剂，10名受试者口服试验药物，2名受试者口服安慰剂。每位受试者接受连续接受口服给药7天，给药后观察14天，完成安全性、药代动力学和药效动力学评价。由研究者判断安全性，再依次继续下一剂量组试验。

干预措施代码：

Intervention：

n this group, subjects were double-blinded and randomly assigned to receive either12μg of the oral test drug or a placebo. Ten subjects received the oral test drug, and two subjects received the placebo. Each subject received continuous oral administration for 7 days and was observed for an additional 14 days following the administration period to complete safety, pharmacokinetic, and pharmacodynamic evaluations. The investigator assessed safety before proceeding to the next dose group in sequence.

Intervention code：

组别：

多剂量爬坡（MAD）-16μg

样本量：

12

Group：

multiple ascending dose(MAD)-16μg

Sample size：

干预措施：

该组受试者按照双盲、随机分配口服试验药物16μg或安慰剂，10名受试者口服试验药物，2名受试者口服安慰剂。每位受试者接受连续接受口服给药7天，给药后观察14天，完成安全性、药代动力学和药效动力学评价。由研究者判断安全性，再依次继续下一剂量组试验。

干预措施代码：

Intervention：

n this group, subjects were double-blinded and randomly assigned to receive either 16μg of the oral test drug or a placebo. Ten subjects received the oral test drug, and two subjects received the placebo. Each subject received continuous oral administration for 7 days and was observed for an additional 14 days following the administration period to complete safety, pharmacokinetic, and pharmacodynamic evaluations. The investigator assessed safety before proceeding to the next dose group in sequence.

Intervention code：

组别：

多剂量爬坡（MAD）-20μg

样本量：

12

Group：

multiple ascending dose(MAD)-20μg

Sample size：

干预措施：

该组受试者按照双盲、随机分配口服试验药物20μg或安慰剂，10名受试者口服试验药物，2名受试者口服安慰剂。每位受试者接受连续接受口服给药7天，给药后观察14天，完成安全性、药代动力学和药效动力学评价。由研究者判断安全性，再依次继续下一剂量组试验。

干预措施代码：

Intervention：

n this group, subjects were double-blinded and randomly assigned to receive either 20μg of the oral test drug or a placebo. Ten subjects received the oral test drug, and two subjects received the placebo. Each subject received continuous oral administration for 7 days and was observed for an additional 14 days following the administration period to complete safety, pharmacokinetic, and pharmacodynamic evaluations. The investigator assessed safety before proceeding to the next dose group in sequence.

Intervention code：

组别：

多剂量爬坡（MAD）-24μg

样本量：

12

Group：

multiple ascending dose(MAD)-24μg

Sample size：

干预措施：

该组受试者按照双盲、随机分配口服试验药物24μg或安慰剂，10名受试者口服试验药物，2名受试者口服安慰剂。每位受试者接受连续接受口服给药7天，给药后观察14天，完成安全性、药代动力学和药效动力学评价。由研究者判断安全性，再依次继续下一剂量组试验。

干预措施代码：

Intervention：

n this group, subjects were double-blinded and randomly assigned to receive either 24μg of the oral test drug or a placebo. Ten subjects received the oral test drug, and two subjects received the placebo. Each subject received continuous oral administration for 7 days and was observed for an additional 14 days following the administration period to complete safety, pharmacokinetic, and pharmacodynamic evaluations. The investigator assessed safety before proceeding to the next dose group in sequence.

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)：

 海淀 

Country：

China 

Province：

Beijing 

City：

Haidian District 

单位(医院)：

中国人民解放军总医院 

单位级别：

三甲 

Institution
hospital：

Chinese PLA General Hospita

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

药代动力学

指标类型：

主要指标

Outcome：

pharmacokinetics

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药效动力学

指标类型：

主要指标

Outcome：

pharmacodynamics

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：

体格检查

指标类型：

主要指标

Outcome：

Physical examination

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血常规

指标类型：

主要指标

Outcome：

Blood Routine

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

尿常规

指标类型：

主要指标

Outcome：

Urine routine

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血生化

指标类型：

主要指标

Outcome：

Blood biochemistry

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

凝血功能

指标类型：

主要指标

Outcome：

Coagulation

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

指标类型：

主要指标

Outcome：

ECG

Type：

Primary 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：

主要指标

Outcome：

Adverse events

Type：

Primary 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：

血管

Sample Name：

Blood

Tissue：

vein

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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）：

SAD：每个剂量组对受试者进行双盲、随机化处理。每组入组8例受试者，按6:2比例，双盲、随机分配接受试验药物或安慰剂给药。 SAD研究每个剂量组单独随机。以SAS软件（9.4或以上版本）产生随机号以及随机号所对应治疗组别。随机表（盲底），一式二份，分别封存在申办方和临床研究负责单位。随机号即作为药物盲法实施的药物号。受试者筛选合格以后，研究人员根据药物号大小顺序依次发放药物。 MAD：每个剂量组对受试者进行双盲、随机化处理。每组入组12例受试者，按10:2比例，双盲、随机分配接受试验药物或安慰剂给药。 MAD研究每个剂量组单独随机。以SAS软件（9.4或以上版本）产生随机号以及随机号所对应治疗组别。随机表（盲底），一式二份，分别封存在申办方和临床研究负责单位。随机号即作为药物盲法实施的药物号。受试者筛选合格以后，研究人员根据药物号大小顺序依次发放药物。

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

SAD: Subjects in each dose group were double-blinded and randomized. Eight subjects were enrolled in each group, with a 6:2 ratio for double-blinded, random assignment to receive either the test drug or placebo. For the SAD study, randomization was conducted separately for each dose group. Random numbers and corresponding treatment groups were generated using SAS software (version 9.4 or above). The randomization list (blind code) was prepared in duplicate and stored separately by the sponsor and the clinical research unit responsible. The random number served as the drug number for the implementation of blinded drug administration. After subjects were screened and qualified, researchers distributed the drugs in sequential order based on the drug numbers. MAD: Subjects in each dose group were double-blinded and randomized. Twelve subjects were enrolled in each group, with a 10:2 ratio for double-blinded, random assignment to receive either the test drug or placebo. For the MAD study, randomization was also conducted separately for each dose group. Random numbers and corresponding treatment groups were generated using SAS software (version 9.4 or above). The randomization list (blind code) was prepared in duplicate and stored separately by the sponsor and the clinical research unit responsible. The random number served as the drug number for the implementation of blinded drug administration. After subjects were screened and qualified, researchers distributed the drugs in sequential order based on the drug numbers.

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：

编盲 药物现场编盲由统计单位人员和申办单位与本试验无关人员参加，将已形成的随机号（药物号）填写（或粘贴）在标签上。编盲过程形成编盲记录保存。编号原则为：不同剂量水平使用不同的编号原则，如，第1剂量水平编号范围101～108，第2剂量水平编号范围201～210，第3剂量水平编号范围301～310，以此类推。 应急信件 本研究采用的是纸质应急信件，每位受试者一份应急信件。信件内密封有随机号对应的组别，应急信件随对应的药物发往中心。 紧急揭盲 紧急情况下，研究者认为知晓受试者所服用药物有利于不良事件的处理时，可拆阅应急信件紧急揭盲。同时在拆阅的应急信件上也应由拆阅的研究者注明紧急破盲的原因、日期并签字。 揭盲规定 本研究揭盲于统计计划书、数据审核报告定稿并数据库锁定后进行，揭晓随机号所对应的组别代码，以便对全部数据进行分组后的统计分析。揭盲文件由主要研究者、申办方、统计人员共同签署。

Blinding：

Drug Coding and Blinding The on-site drug coding and blinding process involved personnel from the statistical unit, the sponsor, and individuals unrelated to the trial. The pre-generated random numbers (drug numbers) were written (or pasted) onto the labels. A record of the coding and blinding process was maintained. The numbering principle was as follows: different numbering principles were used for different dose levels. For example, the numbering range for the first dose level was 101 to 108, for the second dose level it was 201 to 210, and for the third dose level it was 301 to 310, and so on. Emergency Letters This study used paper-based emergency letters, with one letter for each subject. The letter contained the group corresponding to the random number, sealed inside. The emergency letters were sent to the center along with the corresponding drugs. Emergency Unblinding In emergency situations, when the investigator believed that knowing the drug taken by the subject would be beneficial for handling adverse events, the emergency letter could be opened for emergency unblinding. The researcher who opened the letter should indicate the reason for the emergency unblinding, the date, and sign the letter. Unblinding Regulations Unblinding for this study was conducted after the statistical plan, data review report were finalized, and the database was locked. The group codes corresponding to the random numbers were revealed to facilitate statistical analysis of the grouped data. The unblinding document was jointly signed by the principal investigator, the sponsor, and the statisticians.

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)：

NA

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：

本次试验采用CRF与EDC共同完成数据的采集和管理。

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

This test uses CRF and EDC to complete data collection and management.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-10-14 09:43:19