ChiCTR2600125778 版本V1.0 版本创建时间2026/05/31 23:27:19 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：

 ChiCTR2600125778 

最近更新日期：

Date of Last Refreshed on：

 2026-05-31 23:27:15 

注册时间：

Date of Registration：

 2026-05-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价注射用KR25102在中国健康参与者中单次和多次剂量递增静脉给药的安全性、耐受性和药代动力学特征及药效动力学的Ⅰ期临床试验

Public title：

A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Intravenous Doses of KR25102 for Injection in Healthy Chinese Adult Subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价注射用KR25102在中国健康参与者中单次和多次剂量递增静脉给药的安全性、耐受性和药代动力学特征及药效动力学的Ⅰ期临床试验

Scientific title：

A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Intravenous Doses of KR25102 for Injection in Healthy Chinese Adult 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：

黄洁 

研究负责人：

阳国平 

Applicant：

Huang Jie 

Study leader：

Yang Guoping 

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 8938

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 cellahuang1988@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ygp9880@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中国湖南省长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Applicant address：

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

Study leader's address：

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

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中南大学湘雅三医院

Applicant's institution：

Xiangya Third 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：

Xiangya Third 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：

 26061

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：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-19 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Wang Xiaomin

伦理委员会联系地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Contact Address of the ethic committee：

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

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 8861 8938

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中南大学湘雅三医院

Primary sponsor：

The Third Xiangya Hospital, Central South University

研究实施负责（组长）单位地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

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

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

Hunan

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：

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

经费或物资来源：

江西科睿药业有限公司

Source(s) of funding：

Jiangxi Kerui Pharmaceutical Co., Ltd.

研究疾病：

急性疼痛  

Target disease：

Acute pain

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：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评价注射用KR25102在中国健康成年参与者中多次静脉给药后，不同剂量下的人体安全性与耐受性。 评价注射用KR25102在中国健康成年参与者中多次静脉给药后，不同剂量下的人体药代动力学（PK）特征。 评价注射用KR25102对中国健康成年参与者的QTcF间期影响。  

Objectives of Study：

Evaluate the safety and tolerability of multiple intravenous administrations of injectable KR25102 at different dose levels in healthy adult Chinese participants. Evaluate the pharmacokinetic (PK) characteristics of multiple intravenous administrations of injectable KR25102 at different doses in healthy adult Chinese participants. To evaluate the effect of injectable KR25102 on the QTcF interval in healthy adult Chinese participants.

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. 18周岁＜＝年龄＜＝55周岁（以签署知情同意书时为准）的男女参与者； 2. 男性体重＞＝50 kg，女性体重＞＝45 kg，体重指数（BMI）在19～26 kg/m^2之间者（包括临界值）； 3. 参与者及其伴侣自签署知情同意书至末次接受试验药物后2个月内无生育、捐精、捐卵计划，且自愿采取高效避孕措施; 4. 女性参与者：非妊娠期或哺乳期；有生育能力的女性参与者必须在筛选期和基线期进行血清妊娠试验，且结果为阴性； 5. 对需要进行疼痛测试的组别：愿意接受疼痛试验且培训合格者；且接受疼痛刺激部位的皮肤无伤口或皮肤病。 6. 参与者充分了解本试验的目的和要求、潜在的风险，愿意严格遵守全部试验的要求，自愿参加临床试验并签署书面知情同意书。

Inclusion criteria

1. Male and female participants aged 18 to 55 years old (inclusive) at the time of signing the informed consent form; 2. Male participants weighing >=50 kg and female participants weighing >=45 kg, with a body mass index (BMI) between 19 and 26 kg/m^2 (inclusive); 3. Participants and their partners do not plan to conceive, donate sperm, or donate eggs from the time of signing the informed consent form until 2 months after the last administration of the study drug, and voluntarily agree to use effective contraception; 4. Female participants: not pregnant or breastfeeding; women of childbearing potential must undergo serum pregnancy tests during the screening and baseline periods, with negative results; 5. For groups requiring pain testing: willing to undergo pain tests and properly trained; and the skin at the site of pain stimulation has no wounds or dermatological conditions. 6. Participants fully understand the purpose and requirements of this trial, are aware of the potential risks, are willing to strictly comply with all trial requirements, voluntarily participate in the clinical trial, and sign a written informed consent form.

排除标准：

1.既往或目前患有以下疾病，包括但不限于心血管系统、内分泌和代谢系统、神经精神系统、消化系统、呼吸系统、血液和淋巴系统、免疫系统、泌尿系统、运动系统疾病及恶性肿瘤等临床急慢性疾病，且经研究者判定不适宜入组者； 2.既往有遗传性血管性水肿史及家族史者； 3.已知对研究药物或研究药物的任何成份有过敏史者、既往有慢性荨麻疹、严重过敏反应病史、或过敏体质者（对2种及以上药物及食物过敏）； 4.不能耐受静脉给药、静脉采血困难者，有晕针晕血史者； 5.筛选前6个月内接受过重大手术者，或计划在试验期间进行外科手术者； 6.给药前14天内服用过任何药物或保健品者（包括中草药）；或筛选期已知试验期间可能需要接受其他药物治疗者。 7.给药前1个月内使用过任何肝药酶抑制剂/诱导剂（抑制剂如伊曲康唑、克拉霉素、酮康唑、利托那韦、奈非那韦、考比司他、泰利霉素或奈法唑酮等；诱导剂如卡马西平、苯妥英、苯巴比妥、圣约翰草等）者。 8.筛选前3个月内参加过任何临床试验且使用过试验药物/器械者或计划在研究期间参加其他临床试验者。 9.筛选前6个月内献血或失血>=200 mL（不包括女性月经期失血）、接受输血或使用血制品者，或计划在试验期间或试验结束后1个月内献血者。 10.筛选前3个月内每天饮用过量茶（>15g茶叶/天；一般每次泡茶3~5g茶叶）、咖啡和/或富含咖啡因的饮料（8杯以上，1杯=200mL）者或试验期间不能停止使用茶、咖啡和/或富含咖啡因的饮料者，或研究药物给药前2天食用过或住院期间不能停止特殊饮食（如西柚、西柚汁或含西柚汁的食物/饮料）者，或其他影响药物吸收、分布、代谢、排泄的特殊饮食者。 11.嗜烟者：筛选前3个月内平均每日吸烟量大于5支，或试验期间不能戒烟者；嗜酒者：酒精呼气试验阳性者；或筛选前3个月内平均每周饮酒量超过14个单位（1单位≈285 mL酒精含量为3.5%的啤酒，或25 mL酒精含量为40%的烈酒，或85 mL酒精含量为12%的葡萄酒），或试验期间不能戒酒者； 12.有药物滥用史或药物滥用筛查呈阳性者； 13.筛选期或基线期体检结果经研究医生判断为异常有临床意义者； 14.乙型肝炎表面抗原、丙型肝炎病毒抗体、人类免疫缺陷病毒抗体或梅毒螺旋体抗体筛查阳性者； 15.有心脏疾病，包括但不限于先天性长QT综合征、尖端扭转型心脏病或尖端扭转型心脏病的危险因素（如心功能不全、长QT综合征家族史）、目前使用IA类[如奎尼丁或普鲁卡因胺]或III类[如胺碘酮或索他洛尔]抗心律失常药物或其他已知对QT间期有影响的药物，或筛选时按Fridericia’s标准校正的QTc间期（QTcF）＞＝450 ms（男性），（QTcF）＞＝460 ms（女性）或PR间期＞200 ms或QRS间期＞＝120 ms者； 16.筛选前 2 个月内，接种过活（减毒）疫苗，或研究期间计划接种活疫苗者； 17. 研究者判断疼痛测试培训不合格者（仅适用于需要进行疼痛测试的组别）； 18.参与者可能因为其他原因而不能完成本研究或研究者认为不应纳入者。

Exclusion criteria：

1. Have had or currently have any of the following diseases, including but not limited to diseases of the cardiovascular system, endocrine and metabolic systems, neuropsychiatric system, digestive system, respiratory system, blood and lymphatic system, immune system, urinary system, musculoskeletal system, and malignant tumors, as well as other acute and chronic clinical diseases, and deemed unsuitable for enrollment by the investigator; 2. Have a personal or family history of hereditary angioedema; 3. Known allergy to the investigational drug or any component of the investigational drug, history of chronic urticaria, severe allergic reactions, or atopic constitution (allergic to two or more drugs and foods); 4. Unable to tolerate intravenous administration, have difficulty with venous blood collection, or a history of fainting at the sight of needles or blood; 5. Underwent major surgery within 6 months prior to screening, or planning to undergo surgery during the trial; 6. Taken any medication or health supplements (including herbal medicine) within 14 days prior to administration, or known during the screening period to potentially require other medication during the trial; 7. Used any liver enzyme inhibitors/inducers within 1 month prior to administration (inhibitors such as itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin, or nefazodone; inducers such as carbamazepine, phenytoin, phenobarbital, St. John’s wort, etc.); 8. Participated in any clinical trial and used any investigational drug/device within 3 months prior to screening, or plan to participate in another clinical trial during the study; 9. Donated blood or lost >=200 mL of blood (excluding menstrual blood loss in women), received a blood transfusion, or used blood products within 6 months prior to screening, or plan to donate blood during the trial or within 1 month after trial completion; 10. Consumed excessive tea (>15g of tea leaves/day; generally 3–5 g per brew), coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup = 200 mL) daily within 3 months prior to screening, or unable to stop consuming tea, coffee, and/or caffeine-rich beverages during the trial, or consumed special foods (e.g., grapefruit, grapefruit juice, or foods/drinks containing grapefruit juice) within 2 days prior to administration or unable to stop during hospitalization, or other special diets affecting drug absorption, distribution, metabolism, or excretion; 11. Smokers: averaged more than 5 cigarettes per day within 3 months prior to screening, or unable to quit smoking during the trial; drinkers: positive on alcohol breath test, or averaged more than 14 units of alcohol per week within 3 months prior to screening (1 unit ≈ 285 mL beer with 3.5% alcohol, 25 mL spirits with 40% alcohol, or 85 mL wine with 12% alcohol), or unable to abstain from alcohol during the trial; 12. History of substance abuse or positive substance abuse screening; 13. Physical examination results during the screening or baseline period deemed clinically significant abnormalities by the study physician; 14. Individuals who test positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum (syphilis) antibody screening; 15. Individuals with heart disease, including but not limited to congenital long QT syndrome, torsades de pointes, or risk factors for torsades de pointes (such as heart failure or a family history of long QT syndrome), those currently using Class IA (e.g., quinidine or procainamide) or Class III (e.g., amiodarone or sotalol) antiarrhythmic drugs, or other medications known to affect the QT interval, or those with a screening QT interval corrected by Fridericia’s formula (QTcF) >=450 ms (male), QTcF >=460 ms (female), PR interval >200 ms, or QRS interval >=120 ms; 16. Individuals who have received live (attenuated) vaccines within 2 months prior to screening, or plan to receive live vaccines during the study; 17. Individuals deemed by the investigator as failing pain test training (only applicable to groups requiring pain testing); 18. Participants who may be unable to complete this study for other reasons, or whom the investigator considers should not be included.

研究实施时间：

Study execute time：

从 From 2026-03-16 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

Part 1 5mg剂量组（试验组2例，安慰剂组1例）

样本量：

 3

Group：

Part 1: 5 mg dose group (2 cases in treatment group, 1 case in placebo group)

Sample size：

干预措施：

在给药当日早上静脉给予注射用KR25102 5mg或安慰剂，用静脉恒定输液泵给药，输液速度设定为 2ml +/- 0.5ml/min。

干预措施代码：

Intervention：

On the morning of the dosing day, subjects received an intravenous infusion of 5 mg KR25102 for Injection or placebo via a constant-rate intravenous infusion pump at a flow rate of 2 mL+/- 0.5 mL/min.

Intervention code：

组别：

Part 1 10mg剂量组(试验组8例，安慰剂组2例）

样本量：

 10

Group：

Part 1: 10 mg dose group (8 cases in treatment group, 2 case in placebo group)

Sample size：

干预措施：

在给药当日早上静脉给予注射用KR25102 10mg或安慰剂，用静脉恒定输液泵给药，输液速度设定为 2ml +/- 0.5ml/min。

干预措施代码：

Intervention：

On the morning of the dosing day, subjects received an intravenous infusion of 10 mg KR25102 for Injection or placebo via a constant-rate intravenous infusion pump at a flow rate of 2 mL +/- 0.5 mL/min.

Intervention code：

组别：

Part 1 20mg剂量组(试验组8例，安慰剂组2例）

样本量：

 10

Group：

Part 1: 20 mg dose group (8 cases in treatment group, 2 case in placebo group)

Sample size：

干预措施：

在给药当日早上静脉给予注射用KR25102 20mg或安慰剂，用静脉恒定输液泵给药，输液速度设定为 2ml +/- 0.5ml/min。

干预措施代码：

Intervention：

On the morning of the dosing day, subjects received an intravenous infusion of 20 mg KR25102 for Injection or placebo via a constant-rate intravenous infusion pump at a flow rate of 2 mL +/- 0.5 mL/min.

Intervention code：

组别：

Part 1 30mg剂量组(试验组8例，安慰剂组2例）

样本量：

 10

Group：

Part 1 30mg dose group (8 cases in treatment group, 2 case in placebo group)

Sample size：

干预措施：

在给药当日早上静脉给予注射用KR25102 30mg或安慰剂，用静脉恒定输液泵给药，输液速度设定为 2ml +/- 0.5ml/min。

干预措施代码：

Intervention：

On the morning of the dosing day, subjects received an intravenous infusion of 30 mg KR25102 for Injection or placebo via a constant-rate intravenous infusion pump at a flow rate of 2 mL +/- 0.5 mL/min.

Intervention code：

组别：

Part 1 45mg剂量组(试验组8例，安慰剂组2例）

样本量：

 10

Group：

Part 1 45mg dose group (8 cases in treatment group, 2 case in placebo group)

Sample size：

干预措施：

在给药当日早上静脉给予注射用KR25102 45mg或安慰剂，用静脉恒定输液泵给药，输液速度设定为 2ml +/- 0.5ml/min。

干预措施代码：

Intervention：

On the morning of the dosing day, subjects received an intravenous infusion of 45 mg KR25102 for Injection or placebo via a constant-rate intravenous infusion pump at a flow rate of 2 mL +/- 0.5 mL/min.

Intervention code：

组别：

Part 1 60mg剂量组(试验组8例，安慰剂组2例）

样本量：

 10

Group：

Part 1 60mg dose group (8 cases in treatment group, 2 case in placebo group)

Sample size：

干预措施：

在给药当日早上静脉给予注射用KR25102 60mg或安慰剂，用静脉恒定输液泵给药，输液速度设定为 2ml +/- 0.5ml/min。

干预措施代码：

Intervention：

On the morning of the dosing day, subjects received an intravenous infusion of 60 mg KR25102 for Injection or placebo via a constant-rate intravenous infusion pump at a flow rate of 2 mL +/- 0.5 mL/min.

Intervention code：

组别：

Part 2 10mg QD(试验组8例，安慰剂组2例）

样本量：

 10

Group：

Part 2 10mg once daily (8 cases in treatment group, 2 case in placebo group)

Sample size：

干预措施：

在给药当日（D1至D7）早上静脉给予注射用KR25102 10mg或安慰剂（以D1给药时间为参照，每24 h+/- 10 min给药1次），输液速度设定为 2ml +/- 0.5ml/min。

干预措施代码：

Intervention：

On the morning of each dosing day (D1 to D7), subjects received 10 mg KR25102 for Injection or placebo intravenously. Dosing was administered once every 24 h +/- 10 min based on the administration time on D1, with an infusion rate set at 2 mL +/- 0.5 mL/min.

Intervention code：

组别：

Part 2 20mgQD (试验组8例，安慰剂组2例）

样本量：

 10

Group：

Part 2 20mg once daily (8 cases in treatment group, 2 case in placebo group)

Sample size：

干预措施：

在给药当日（D1至D7）早上静脉给予注射用KR25102 20mg或安慰剂（以D1给药时间为参照，每24 h+/- 10 min给药1次），输液速度设定为 2ml+/- 0.5ml/min。

干预措施代码：

Intervention：

On the morning of each dosing day (D1 to D7), subjects received 20 mg KR25102 for Injection or placebo intravenously. Dosing was administered once every 24 h +/- 10 min based on the administration time on D1, with an infusion rate set at 2 mL +/- 0.5 mL/min.

Intervention code：

组别：

Part 2 30mgQD (试验组8例，安慰剂组2例）

样本量：

 10

Group：

Part 2 30mg once daily (8 cases in treatment group, 2 case in placebo group)

Sample size：

干预措施：

在给药当日（D1至D7）早上静脉给予注射用KR25102 30mg或安慰剂（以D1给药时间为参照，每24 h+/- 10 min给药1次），输液速度设定为 2ml +/- 0.5ml/min。

干预措施代码：

Intervention：

On the morning of each dosing day (D1 to D7), subjects received 30 mg KR25102 for Injection or placebo intravenously. Dosing was administered once every 24 h +/- 10 min based on the administration time on D1, with an infusion rate set at 2 mL +/- 0.5 mL/min.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China

Province：

Hunan

City：

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三级甲等 

Institution
hospital：

Third Xiangya Hospital, Central South University

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：

次要指标

Outcome：

Pharmacokinetic

Type：

Secondary 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：

12导联心电图指标

指标类型：

主要指标

Outcome：

12-lead ECG indicators

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

动态心电图

指标类型：

主要指标

Outcome：

Ambulatory electrocardiogram

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

冷痛检测阈值

指标类型：

次要指标

Outcome：

Cold pain detection threshold

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

热痛检测阈值

指标类型：

次要指标

Outcome：

Heat pain detection threshold

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛耐受时间

指标类型：

次要指标

Outcome：

Pain tolerance time

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 55 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）：

研究采用随机设计，由独立的非盲统计师使用SAS 9.4版本或更高版本生成各剂量组的随机表。随机表的结果具有重现性，所设定的随机种子参数需要保存。 筛选成功后，各剂量组计划入组受试者根据筛选号由小到大顺序分配随机号。随机号格式为“X-YYY”，其中X为剂量组代码(SAD各组依次编为A~F，MAD各组依次编为G~I),YYY为3位阿拉伯数字流水号。例如:SAD 10mg组(B组)第3例受试者的随机号为B-003，以此类推。

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

This study adopts a randomized design. Independent unblinded statisticians generate randomization tables for each dose group using SAS version 9.4 or above. The results of the randomization tables are reproducible, and the set random seed parameters shall be preserved. After successful screening, the planned enrolled subjects in each dose group are assigned random numbers in ascending order of their screening numbers. The random number is formatted as "X-YYY", where X represents the dose group code (groups in the SAD trial are coded sequentially from A to F, and groups in the MAD trial are coded sequentially from G to I), and YYY is a three-digit serial number. For example, the random number of the 3rd subject in the 10mg SAD group (Group B) is B-003, and so on.

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：

本试验采用双盲设计，在整个研究周期内所有参与者对自身接受研究药物或安慰剂的分组情况保持全程盲态；除预设的非盲人员外，研究者、参与试验及临床评定的医务人员、监查员、医学经理、安全经理、统计师、医学总监以及第三方合同试验机构（PK 浓度检测机构除外）相关人员均对参与者的用药分组不知情，仅配药人员、申办者指定的药理学家及 PK 浓度检测机构相关人员处于非盲状态，用于实时跟进试验安全性与药代动力学参数的相关性，为试验剂量递增及潜在剂量调整提供数据支撑。

Blinding：

Throughout the entire research process, participants remained blinded to whether they received the study drug or a placebo. This trial adopts a double-blind design. All participants remain fully blinded to their treatment assignment of investigational drug or placebo throughout the entire study period. Except for pre-specified unblinded personnel, investigators, medical staff involved in the trial and clinical evaluation, monitors, medical managers, safety managers, statisticians, medical directors and relevant staff of third-party contracted trial institutions (excluding PK concentration testing institutions) are unaware of the participants’ treatment allocation. Only drug dispensing personnel, sponsor-designated pharmacologists and staff of PK concentration testing institutions are unblinded to real-time monitor the correlation between trial safety and pharmacokinetic parameters, and provide data support for dose escalation and potential dose adjustment.

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

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

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

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

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

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

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

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-05-31 23:27:15