ChiCTR2600121364 版本V1.0 版本创建时间2026/03/30 11:01:20 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：

 ChiCTR2600121364 

最近更新日期：

Date of Last Refreshed on：

 2026-03-30 10:59:44 

注册时间：

Date of Registration：

 2026-03-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

SAL0150片在健康试验参与者和肥胖试验参与者中单次和多次给药的安全性、耐受性、药代动力学和药效学研究

Public title：

A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0150 Tablets in Healthy Participants and Participants with Obesity

注册题目简写：

English Acronym：

研究课题的正式科学名称：

SAL0150片在健康试验参与者和肥胖试验参与者中单次和多次给药的安全性、耐受性、药代动力学和药效学研究

Scientific title：

A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0150 Tablets in Healthy Participants and Participants with Obesity

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：

王强 

研究负责人：

谢志红 

Applicant：

Qiang Wang 

Study leader：

Zhihong Xie 

申请注册联系人电话：

Applicant telephone：

 +86 135 2202 5130

研究负责人电话：

Study leader's
telephone：

+86 20 3415 3599

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：

 wangqiang@salubris.com

研究负责人电子邮件：

Study leader's E-mail：

 xzh0302@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：

深圳市福田区福保街道福保社区红柳道2号289数字半岛4层A区

研究负责人通讯地址：

广州市海珠区昌岗东路250号

Applicant address：

Area A, 4th Floor, 289 Digital Peninsula, No. 2 Hongliu Road, Fubao Community, Fubao Street, Futian

Study leader's address：

250 Changgang East Road, Haizhu District, Guangzhou

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：

深圳信立泰药业股份有限公司

Applicant's institution：

Shenzhen Salubris Pharmaceuticals Co., Ltd.

研究负责人所在单位：

广州医科大学附属第二医院

Affiliation of the Leader：

Second Affiliated Hospital of Guangzhou Medical 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：

 Y2026-03-02

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：

广州医科大学附属第二医院临床试验伦理委员会

Name of the ethic committee：

Clinical Trial Ethics Committee of the Second Affiliated Hospital of Guangzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-20 00:00:00

伦理委员会联系人：

杜潇潇

Contact Name of the ethic committee：

Du XiaoXiao

伦理委员会联系地址：

广州市海珠区昌岗东路250号

Contact Address of the ethic committee：

250 Changgang East Road, Haizhu District, Guangzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 3415 3599

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 gyeyec@163.com

研究实施负责（组长）单位：

广州医科大学附属第二医院

Primary sponsor：

Second Affiliated Hospital of Guangzhou Medical University

研究实施负责（组长）单位地址：

广州市海珠区昌岗东路250号

Primary sponsor's address：

250 Changgang East Road, Haizhu District, Guangzhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

广州医科大学附属第二医院

具体地址：

广州市海珠区昌岗东路250号

Institution
hospital：

Second Affiliated Hospital of Guangzhou Medical University

Address：

250 Changgang East Road, Haizhu District, Guangzhou

经费或物资来源：

深圳信立泰药业股份有限公司

Source(s) of funding：

Shenzhen Salubris Pharmaceuticals Co., Ltd.

研究疾病：

T2D患者的血糖控制、T2D患者合并PAD的间接性跛行的症状改善、体重管理等适应证。  

Target disease：

Indications for T2D patients include glycemic control, improvement of intermittent claudication symptoms in patients with T2D and PAD, and weight management.

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

Part A：单次给药剂量递增（SAD）研究 评价SAL0150片在健康试验参与者和肥胖试验参与者中单次口服给药的安全性和耐受性； 评价SAL0150片在健康试验参与者和肥胖试验参与者中单次口服给药的药代动力学、免疫原性和药效学特征。 Part B：多次给药剂量递增（MAD）研究 评价SAL0150片在健康试验参与者和肥胖试验参与者中每周一次（QW）或每两周一次（Q2W）连续给药三个月的安全性和耐受性； 评价SAL0150片在健康试验参与者和肥胖试验参与者中每周一次（QW）或每两周一次（Q2W）连续给药三个月的药代动力学、免疫原性和药效学特征； 评价SAL0150血药浓度与QTc的关系。  

Objectives of Study：

Part A: Single Dose Escalation (SAD) Study Evaluate the safety and tolerability of SAL0150 tablets when administered orally once at a single dose in healthy trial participants and obese trial participants; Evaluate the pharmacokinetics, immunogenicity and pharmacodynamic characteristics of SAL0150 tablets when administered orally once at a single dose in healthy trial participants and obese trial participants.Part B: Multiple Dose Escalation (MAD) Study Evaluate the safety and tolerability of SAL0150 tablets when administered continuously once a week (QW) or once every two weeks (Q2W) for three months in healthy trial participants and obese trial participants; Evaluate the pharmacokinetics, immunogenicity and pharmacodynamic characteristics of SAL0150 tablets when administered continuously once a week (QW) or once every two weeks (Q2W) for three months in healthy trial participants and obese trial participants;Evaluate the relationship between SAL0150 blood concentration and QTc.

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)对本研究已充分了解并自愿签署书面知情同意书，能够遵守知情同意书中所列的要求和限制；
2)年龄18~55周岁（包含18周岁和55周岁）的男性或女性试验参与者；
3)健康试验参与者筛选时男性体重≥50?kg，女性体重≥45?kg；且Part A部分身体质量指数（BMI）在19.0~24.0 kg/m2之间，Part B部分BMI在19.0~28.0 kg/m2之间（包含边界值；BMI = 体重÷身高2）；
4)肥胖试验参与者筛选时BMI≥28.0 kg/m2且3个月内体重变化<5%；
5)筛选时各项检查（包括体格检查、生命体征、血常规、尿常规、血生化、凝血功能和甲状腺功能等）结果无异常或经研究者判断异常无临床意义；
6)12-导联心电图检查中QTcF男性≤450?ms，女性≤470?ms者；其中6b组男女性均需≤450?ms； 7)试验参与者或其伴侣在研究期间及研究药物末次给药后3个月内无妊娠计划，自愿采取有效避孕措施（研究期间禁止使用避孕药）避免使自己或伴侣怀孕，且试验参与者不因生殖或辅助生殖目的捐献精子或卵子（卵细胞、卵母细胞）。

Inclusion criteria

1 People who have fully understood this research and voluntarily signed the written informed consent form. I am capable of complying with the requirements and restrictions listed in the informed consent document. 2 Male or female trial participants aged between 18 and 55 years old (inclusive of 18 and 55 years old); 3 For the screening of the participants in the health trial, the male participants had a body weight of >= 50 kg, and the female participants had a body weight of >= 45 kg; and for Part A, the body mass index (BMI) was within the range of 19.0 to 24.0 kg/m^2, and for Part B, the BMI was within the range of 19.0 to 28.0 kg/m^2 (including the boundary values; BMI = weight / height^2). 4 For the participants in the obesity trial, the screening criteria were: BMI >= 28.0 kg/m^2 and a weight change of less than 5% within 3 months. 5 During the screening process, the results of all examinations (including physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation function, and thyroid function, etc.) were normal or, based on the investigator's judgment, the abnormalities were deemed to have no clinical significance. 6 In the 12-lead electrocardiogram examination, for males, the QTcF value should be <= 450 ms, and for females, it should be <= 470 ms. Among them, for group 6b, both males and females need to have a value of <= 450 ms. 7 The participants in the trial or their partners should have no pregnancy plans during the study period and within 3 months after the last administration of the study drug. They voluntarily take effective contraceptive measures (contraceptive pills are prohibited during the study period) to avoid getting pregnant themselves or their partners pregnant, and the participants in the trial do not donate sperm or egg cells (egg cells, oocyte) for reproductive or assisted reproductive purposes.

排除标准：

1)妊娠、哺乳期妇女，或育龄期女性妊娠筛查结果呈阳性，或育龄期女性试验参与者首次给药前14天内发生过无保护措施的性行为；
2)筛选前2周有临床意义的急性药物或食物过敏反应史，或过敏体质（如对两种或以上药物、食物或花粉过敏），或有变态反应性病史（如哮喘、荨麻疹、湿疹性皮炎等），或经研究者判断可能或明确对研究药物（包括同类药物或对照药物）及其中任何辅料过敏、存在超敏反应或有临床意义的显著反应；
3)乙肝病毒表面抗原、丙肝病毒抗体、人免疫缺陷病毒抗体和梅毒螺旋体特异性抗体检查任一结果呈阳性；
4)筛选时血清降钙素（CT）>50?ng/L；
5)首次给药前使用了以下任何一种食物、药物或治疗：?首次给药前12周内使用过任何GLP-1受体激动剂或含相同靶点的类似药物（如：司美格鲁肽、利拉鲁肽、度拉糖肽、艾塞那肽、替尔泊肽或其他试验阶段的含有GLP-1及其他相关减重靶点的药物）； ?首次给药前12周内使用过全身性糖皮质激素、对体重有显著影响的三环类抗抑郁药、精神疾病用药或镇静类药物； ?首次给药前12周内使用过用于减重或控制体重的处方药、非处方药、中草药和食物补充剂（包括保健食品、代餐食品等）； ?首次给药前12周内接受过以减重为目的的针灸、理疗等非药物治疗； ?首次给药前2周内使用过任何处方药、非处方药、中草药和食物补充剂（包括维生素、保健食品等）； ?首次给药前48小时食用过含葡萄柚（西柚）的食物或饮料或不同意首次给药前48小时内至出组期间禁食含葡萄柚（西柚）的食物或饮料； ?首次给药前48小时内食用过含咖啡因（如：浓茶、咖啡、可乐）或富含黄嘌呤（如：巧克力、可可豆）的食物或饮料或不同意首次给药前48小时内至出组期间禁食含咖啡因（如：浓茶、咖啡、可乐）或富含黄嘌呤（如：巧克力、可可豆）的食物或饮料。
6)患有以下任何一种疾病或病史： ?继发疾病或药物导致肥胖，包括：皮质醇激素升高（如库欣综合征）、垂体和下丘脑损伤导致的肥胖、减肥药减量/停用导致的肥胖等； ?1型或2型糖尿病； ?既往或已知有急性或慢性胰腺炎病史、胰腺损伤病史、急性胆囊炎病史或有症状/需治疗的胆囊疾病（已接受胆囊切除的试验参与者经研究者判断可以入组的除外）； ?甲状腺C细胞癌、MEN（多发性内分泌腺瘤病）2A或2B，或存在相关家族史； ?既往进行过胃部减重手术，或筛选前1年内进行过抽脂术或去脂术，或计划在研究期间计划进行减重手术、抽脂术或腹部去脂术等明显影响体重的手术； ?中重度抑郁症病史，或有其他严重的精神疾病史，或有自杀倾向或自杀行为； ?首次给药前6个月内发生过严重低血糖或反复（6个月内≥2次）症状性低血糖； ?其他影响糖代谢的严重的内分泌系统疾病史，如多发性内分泌腺瘤、肢端肥大综合征、库欣综合征； ?存在临床显著的胃排空异常（如：严重的胃轻瘫或胃出口梗阻）； ?既往诊断为增殖性视网膜病变（PDR）或3期非增殖性视网膜病变（NPDR）。
7)毒品或药物滥用、酗酒或嗜烟： ?有吸毒或药物滥用史，或筛选时尿液药物筛查结果呈阳性； ?筛选前3个月平均每周饮酒量大于14个单位（1单位≈17.7 mL乙醇，即1单位≈酒精量5%的啤酒360 mL，或酒精量40%的白酒45 mL，或酒精量12%的葡萄酒150 mL），或筛选时酒精呼气测试结果呈阳性，或不能在研究期间完全停止食用任何含有酒精成分的食物或饮品； ?筛选前3个月平均每日吸烟量多于5支，或不能在研究期间完全停止使用任何烟草类产品。
8)筛选前3个月内献血（包括成分献血）或失血≥400 mL，筛选前1个月内献血（包括成分献血）或失血≥200 mL或接受过输血，或计划在研究期间或研究结束后1个月内献血或血液成分；
9)采血困难或不能忍受多次静脉穿刺，或研究者判断有临床意义的晕针或晕血史；
10)有吞咽困难者，或对饮食有特殊要求不能遵守统一饮食；
11)筛选前3个月内接种过活疫苗、减毒活疫苗或任何活病毒成分的疫苗，或计划在研究期间或研究结束后1个月内接种上述疫苗；
12)筛选前3个月内经历过严重创伤或接受过重大外科手术（如需全身麻醉），或计划在研究期间或研究结束后3个月内进行手术（局部麻醉手术除外）；
13)筛选前3个月内参加过或正在参加任何干预性临床研究（包括试验性药物或疫苗，以及本研究药物的其他临床研究或本研究的其他队列）并接受过研究用药物；
14)研究者判断存在其他的有临床意义或可能妨碍试验参与者完成此研究的疾病或病史（包括各系统如：呼吸、心血管、消化、泌尿生殖、血液、内分泌、神经、精神以及恶性肿瘤等），或其他可能显著改变药物吸收、代谢或清除的疾病或病史（如胃肠手术、肾脏手术或胆囊切除术等判断可能影响药物体内处置过程的手术史），或感染性疾病；
15)研究者认为依从性差，或具有任何不宜参加此试验的其他因素者。

Exclusion criteria：

1 Pregnant or lactating women, or women of childbearing age whose pregnancy screening results are positive, or women of childbearing age who had unprotected sexual intercourse within 14 days before the first administration of the test; 2 Exclude cases with a history of clinically significant acute drug or food allergy reactions within the past 2 weeks, or with an allergic constitution (such as being allergic to two or more drugs, foods, or pollen), or with a history of allergic disorders (such as asthma, urticaria, eczema, etc.), or where the investigator determines that the subject may or is definitely allergic to the study drug (including similar drugs or control drugs), to any of its excipients, or has a hypersensitivity reaction or a clinically significant significant reaction; 3 Any of the following test results is positive: hepatitis B surface antigen test, hepatitis C virus antibody test, human immunodeficiency virus antibody test, and syphilis spirochete specific antibody test. 4 During the screening process, the serum calcitonin (CT) level was greater than 50 ng/L; 5 Before the first administration, any of the following foods, drugs or treatments were used: (1) Within 12 weeks prior to the first administration, any GLP-1 receptor agonist or similar drugs targeting the same target (such as semaglutide, liraglutide, dulaglutide, exenatide, tiraglutide, or other drugs in the trial stage containing GLP-1 and other related weight loss targets) were used; (2) Within 12 weeks prior to the first administration, systemic glucocorticoids, tricyclic antidepressants with significant impact on weight, psychiatric medications or sedatives were used; (3) Within 12 weeks prior to the first administration, prescription drugs, over-the-counter drugs, herbal medicines and food supplements (including health foods, meal replacement foods, etc.) for weight loss or weight control were used; (4) Within 12 weeks prior to the first administration, acupuncture, physical therapy and other non-drug treatments for weight loss were received; (5) Within 2 weeks prior to the first administration, any prescription drugs, over-the-counter drugs, herbal medicines and food supplements (including vitamins, health foods, etc.) were used; (6) Within 48 hours prior to the first administration, foods or beverages containing grapefruit (mandarin orange) or foods or beverages containing caffeine (such as strong tea, coffee, cola) or foods or beverages rich in xanthine (such as chocolate, cocoa beans) were consumed, or it was agreed not to consume foods or beverages containing caffeine (such as strong tea, coffee, cola) or foods or beverages rich in xanthine (such as chocolate, cocoa beans) within 48 hours prior to the first administration and until the end of the study period. 6 Have any of the following diseases or medical histories: (1) Obesity caused by secondary diseases or medications, including: elevated cortisol levels (such as Cushing's syndrome), obesity resulting from damage to the pituitary and hypothalamus, obesity caused by reducing or discontinuing weight-loss medications, etc.; (2) Type 1 or Type 2 diabetes; (3) Previous or known history of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/requiring treatment gallbladder diseases (except for trial participants who have undergone gallbladder removal and have been judged by the researchers to be eligible for inclusion); (4) Thyroid C-cell cancer, MEN (Multiple Endocrine Adenoma Disease) type 2A or 2B, or a related family history; (5) Previous gastric weight loss surgery, or liposuction or fat removal surgery within 1 year before screening, or planned weight loss surgery, liposuction, or abdominal fat removal surgery during the study period that significantly affects body weight; (6) Severe depression history, or a history of other serious mental illnesses, or suicidal tendencies or behaviors; (7) Had severe hypoglycemia within 6 months before the first administration or recurrent (>=2 times within 6 months) symptomatic hypoglycemia; (8) Other severe endocrine system diseases affecting glucose metabolism, such as multiple endocrine adenomas, acromegaly syndrome, Cushing's syndrome; (9) Presence of clinically significant gastric emptying abnormalities (such as severe gastroparesis or gastric outlet obstruction); (10) Previously diagnosed as proliferative retinopathy (PDR) or stage 3 non-proliferative retinopathy (NPDR). 7 Drug or substance abuse, alcoholism or smoking addiction: (1) History of drug use or substance abuse, or positive urine drug screening result during screening; (2) Average weekly alcohol consumption over the past 3 months was more than 14 units (1 unit ≈ 17.7 mL ethanol, which is approximately 360 mL of 5% alcohol beer, or 45 mL of 40% alcohol liquor, or 150 mL of 12% alcohol wine), or positive alcohol breath test result during screening, or unable to completely stop consuming any food or beverage containing alcohol during the study period; (3) Average daily cigarette consumption over the past 3 months was more than 5 cigarettes, or unable to completely stop using any tobacco products during the study period. 8 Subjects who have donated blood (including component blood donation) within the past 3 months, or have undergone blood loss of >= 400 mL, or have donated blood (including component blood donation) or had blood loss of >= 200 mL within the past 1 month, or have received blood transfusion, or plan to donate blood or blood components during the study period or within 1 month after the study ends. 9 Difficulties in blood collection or inability to tolerate multiple venipunctures; or a history of clinically significant fainting or hemoversion as determined by the researcher; 10 Those who have difficulty in swallowing, or have special dietary requirements that cannot be accommodated within the unified diet; 11 Exclude those who have received live vaccines, attenuated live vaccines, or any vaccines containing live viral components within the previous 3 months, or those who plan to receive such vaccines during the study period or within 1 month after the study concludes. 12 Exclusion criteria: Participants who have experienced severe trauma or undergone major surgical procedures within the past 3 months (including those requiring general anesthesia), or who plan to undergo surgery (excluding local anesthesia surgeries) during the study period or within 3 months after the study ends; 13 Those who have participated in or are currently participating in any interventional clinical studies within the past 3 months (including experimental drugs or vaccines, as well as other clinical studies of the investigational drug or other cohorts of this study); and have received the study drugs. 14 The researchers determine that there are other diseases or medical histories that have clinical significance or may prevent the trial participants from completing this study (including various systems such as the respiratory, cardiovascular, digestive, urinary reproductive, hematological, endocrine, neurological, mental, and malignant tumor systems); or other diseases or medical histories that may significantly alter drug absorption, metabolism, or clearance (such as surgical histories like gastrointestinal surgery, kidney surgery, or cholecystectomy that may affect the drug's in-body disposition process); or infectious diseases. 15 The researchers considered those who had poor compliance or any other factors that made them unsuitable for participating in this trial.

研究实施时间：

Study execute time：

从 From 2026-03-30 00:00:00至 To 2026-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-30 00:00:00 至 To 2026-10-31 00:00:00

干预措施：

Interventions：

组别：

Part A部分SAL0150 治疗组

样本量：

 108

Group：

Part A Section SAL0150 Treatment Group

Sample size：

干预措施：

SAL0150片

干预措施代码：

Intervention：

SAL0150 Tablet

Intervention code：

组别：

Part A部分安慰剂组

样本量：

 18

Group：

Part A Section Placebo Group

Sample size：

干预措施：

安慰剂

干预措施代码：

Intervention：

Placebo

Intervention code：

组别：

Part B部分6a组 司美格鲁肽注射液

样本量：

 14

Group：

Part B Section 6a Group: Semedulide inj

Sample size：

干预措施：

司美格鲁肽注射液

干预措施代码：

Intervention：

Semedulide inj

Intervention code：

组别：

Part B部分6a组 SAL0150

样本量：

 14

Group：

Part B: 6a Group SAL0150

Sample size：

干预措施：

SAL0150片

干预措施代码：

Intervention：

SAL0150 Tablet

Intervention code：

组别：

Part B部分7a组

样本量：

 20

Group：

Part B Section 7a Group

Sample size：

干预措施：

SAL0150片

干预措施代码：

Intervention：

SAL0150 Tablet

Intervention code：

组别：

Part B部分6b组

样本量：

 20

Group：

Part B Section 6b Group

Sample size：

干预措施：

SAL0150片

干预措施代码：

Intervention：

SAL0150 Tablet

Intervention code：

组别：

Part B部分7b组

样本量：

 20

Group：

Part B Section 7b Group

Sample size：

干预措施：

SAL0150片

干预措施代码：

Intervention：

SAL0150 Tablet

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 广州医科大学附属第二医院 

单位级别：

 三级甲等 

Institution
hospital：

Second Affiliated Hospital of Guangzhou Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 苏州大学附属第二医院 

单位级别：

 三级甲等 

Institution
hospital：

Second Affiliated Hospital of Soochow University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

免疫原性相关指标

指标类型：

主要指标

Outcome：

Immunogenicity-related indicators

Type：

Primary indicator

测量时间点：

0h-D120

测量方法：

采用经验证的方法检测试验参与者血清中抗药抗体（Anti-drug antibody, ADA）的产生情况，对于ADA确证为阳性的样本，经评估后确定是否进行中和抗体（Neutralizing antibody, Nab）分析。对ADA和/或Nab阳性的出现时间、抗体滴度、抗体阳性例数和发生率等进行描述。

Measure time point of outcome：

0h-D120

Measure method：

The production of anti-drug antibodies (Anti-drug antibody, ADA) in the serum of the experimental participants was tested using an established method. For samples with confirmed positive ADA, the analysis of neutralizing antibodies (Neutralizing antibody, Nab) was determined after evaluation. The occurrence time, antibody titer, number of positive cases and incidence rate of ADA and/or Nab positivity were described.

指标中文名：

药代动力学参数

指标类型：

主要指标

Outcome：

pharmacokinetic parameters

Type：

Primary indicator

测量时间点：

0h-D120

测量方法：

Cmax、AUClast、AUCinf、Tmax、T1/2、Vz/F、CL/F、AUC_%Extrap和λz等；通过血药浓度实测值计算

Measure time point of outcome：

0h-D120

Measure method：

Cmax、AUClast、AUCinf、Tmax、T1/2、Vz/F、CL/F、AUC_%Extrapλz were calculated based on the measured blood drug concentration values

指标中文名：

安全性评价

指标类型：

主要指标

Outcome：

Safety index

Type：

Primary indicator

测量时间点：

整个试验期间

测量方法：

安全性评价将在筛选期、给药期和安全性随访期进行。提前退出的试验参与者应在退出前进行安全性评价。 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、心电图、以及因安全性或耐受性原因而提前退出的情况等。

Measure time point of outcome：

The entire experimental process

Measure method：

The safety assessment will be conducted during the screening period, the administration period and the safety follow-up period. Participants who withdraw prematurely should undergo a safety assessment before withdrawal. The safety observation indicators include: adverse events, vital signs, physical examination, laboratory tests, electrocardiogram, and situations where withdrawal is premature due to safety or tolerability reasons, etc.

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：

标本中文名：

血浆

组织：

Sample Name：

Plasma

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：

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）：

各剂量组由随机化统计师采用SAS（9.4或更高版本）软件按照区组随机方法生成随机分配表，在各剂量组内以6:1的比例将试验参与者随机分配至SAL0150治疗组或安慰剂治疗组。

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

SAS（9.4），6:1SAL0150。Each dose group was generated by a randomization statistician using the SAS (version 9.4 or higher) software according to the block randomization method. Within each dose group, the trial participants were randomly assigned to the SAL0150 treatment group or the placebo treatment group in a 6:1 ratio.

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：

开放标签，对评估者隐藏分组

Blinding：

Open-label study with blinded-evaluators

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）：

none

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：

EDC

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

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-03-30 10:59:44