ChiCTR2300073564 版本V1.0 版本创建时间2023/07/14 11:11:37 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：

 ChiCTR2300073564 

最近更新日期：

Date of Last Refreshed on：

 2023-07-14 11:10:57 

注册时间：

Date of Registration：

 2023-07-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

健康受试者单次静脉或皮下给予SHR-2106后的安全性、耐受性、药代动力学和药效学I期临床研究

Public title：

A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2106 Following Single Intravenous or Subcutaneous Administration in Healthy Subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

健康受试者单次静脉或皮下给予SHR-2106后的安全性、耐受性、药代动力学和药效学I期临床研究

Scientific title：

A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2106 Following Single Intravenous or Subcutaneous Administration 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：

严新 

研究负责人：

阳国平 

Applicant：

Yanxin 

Study leader：

Guoping Yang 

申请注册联系人电话：

Applicant telephone：

 +86 138 7017 3936

研究负责人电话：

Study leader's
telephone：

+86 731 8991 8665

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：

 1394091764@qq.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：

湖南省长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

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

Study leader's address：

No. 138, Tongzipo Road, Yuelu District, Changsha City, Hunan 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：

中南大学湘雅三医院临床试验中心

Applicant's institution：

Clinical Trial Center of the Third Xiangya Hospital of Central South University

研究负责人所在单位：

中南大学湘雅三医院临床试验中心

Affiliation of the Leader：

Clinical Trial Center of the Third Xiangya 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：

 快23440

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：

IRB,theThird Xiangya Hospital of Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-07-03 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Xiaomin Wang

伦理委员会联系地址：

湖南省长沙市岳麓区桐梓坡路138号中南大学湘雅三医院伦理委员会

Contact Address of the ethic committee：

IRB,theThird Xiangya Hospital of Central South University,138Tongzipo 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临床试验中心

Primary sponsor：

Clinical Trial Center of Third Xiangya Hospital of Central South University

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

138Tongzipo 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)：

Country：

China

Province：

HuNan

City：

单位(医院)：

中南大学湘雅三医院

具体地址：

湖南省长沙市岳麓区桐梓坡路138号

Institution
hospital：

Third Xiangya Hospital, Central South University

Address：

138138 Tongzipo Road,Yuelu District,Changsha,Hunan,China

经费或物资来源：

广东恒瑞医药有限公司

Source(s) of funding：

Guangdong Hengrui Medicine Co.

研究疾病：

移植术后排异反应  

Target disease：

Post-transplantation rejection

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：

主要研究目的：评价健康受试者单次静脉或皮下给予 SHR-2106 后的安全性和耐受性 次要研究目的： 评价健康受试者单次静脉或皮下给予 SHR-2106 后的药代动力学特征； 评价健康受试者单次静脉或皮下给予 SHR-2106 后的免疫原性特征 探索性研究目的：评估健康受试者单次静脉或皮下给予 SHR-2106 后的药效学特征  

Objectives of Study：

Primary Study Objective: To evaluate the safety and tolerability of SHR-2106 following a single intravenous or subcutaneous dose in healthy subjects. Secondary Study Objective: To evaluate the pharmacokinetic profile of SHR-2106 following a single intravenous or subcutaneous dose in healthy subjects; to evaluate the immunogenicity profile of SHR-2106 following a single intravenous or subcutaneous dose in healthy subjects. Purpose of the Exploratory Study: To evaluate the pharmacodynamic profile of SHR-2106 following a single intravenous or subcutaneous dose 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. 在试验相关的任何活动开始之前，获得知情同意，并对本次试验的目的和意义有 充分了解，愿意遵守试验方案； 2. 年龄 18 ~ 55 岁（含边界值），男女不限； 3. 男性体重≥ 50 kg，女性体重≥ 45 kg，体重指数（BMI）＝体重（kg）/身高 2 （m2），BMI 在 19 ~ 28 kg/m2范围内（含边界值）； 4. 随机前体格检查、生命体征、实验室检查（血常规、尿常规、血生化、凝血功 能）、甲状腺功能、胸部正位片、12-导联心电图检查结果正常或异常无临床意义； 5. 受试者及其伴侣在研究期间至试验末次用药后（各剂量组间末次随访时间见表 9） 9 个月（接受 SHR-2106 治疗的女性受试者）或 6 个月（接受 SHR-2106 治疗的男 性受试者）内无生育计划、不捐献精子/卵子且自愿采取高效避孕措施（具体避孕 措施见方案附件 1），女性受试者血清妊娠试验必须是阴性，且为非哺乳期。

Inclusion criteria

1. obtain informed consent prior to the commencement of any activity related to the trial and have a full understanding of the purpose and significance of this trial Full understanding and willingness to comply with the trial protocol; 2. be aged 18 ~ 55 years (including borderline values), male and female; 3. male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) = weight (kg)/height 2 (m2), BMI in the range of 0.5 to 0.5, BMI in the range of 0.5 to 0.5. (Body mass index (BMI) = weight (kg)/height 2 (m2 ), BMI within the range of 19 ~ 28 kg/m2 (including boundary value). 4; 4. Pre-random physical examination, vital signs, laboratory tests (routine blood, urine, blood biochemistry, coagulation function), thyroid function, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose and blood glucose. (blood, urine, blood biochemistry, coagulation), thyroid function, chest radiographs, and 12-lead electrocardiograms were normal or abnormal without clinical significance; 5. subjects and their partners during the study period until after the last dose of the trial (see Table 9 for final follow-up between dose groups). 9 months (female subjects treated with SHR-2106) or 6 months (male subjects treated with SHR-2106) without having a child. No birth plan within 9 months (for female subjects treated with SHR-2106) or 6 months (for male subjects treated with SHR-2106), no sperm/egg donation, and voluntary use of highly effective contraception (see Annex 1 of the programme for details). The female subject must have a negative serum pregnancy test and not be lactating.

排除标准：

1. 筛选时受试者病史、症状及检查结果提示患有活动性结核或潜伏性结核。将通过 γ 干扰素释放试验（Interferon gamma release assay，IGRA）和胸部正侧位片（X 线） 检验筛查所有受试者的结核病状况。在筛选前 1 个月内进行了 IGRA 和 X 线检查 的受试者，根据研究者的判断，可在筛选时不再重复进行 IGRA 和 X 线检查； ? IGRA 检验结果不为阴性； ? 如果 IGRA 结果为不确定，允许重新进行检验。2 次检验结果都不确定的受试 者将被排除在研究之外； 2. 既往有严重心血管、肝脏、肾脏、消化道、精神神经、血液学、代谢异常等疾病 病史（5 年内）； 3. 筛选或给药前 6 个月内有严重感染、严重外伤或外科大手术者；计划在试验期间 接受手术者； 4. 筛选前 12 个月内存在慢性感染或复发性感染且需要治疗者； 5. 筛选或给药前 1 个月内献血或失血总量≥ 200 mL，或者给药前 3 个月内献血或失 血总量≥ 400 mL，或在 2 个月内接受过输血者； 6. 对两种或以上食物药物有过敏史者；或已知对研究药物或研究药物中任何成分 （注射剂成分见方案附件 2）有过敏史者； 7. 筛选前 3 个月内有嗜烟史，嗜烟的定义为：平均每日抽烟 5 支以上；或在研究期 间不能遵循禁止吸烟要求者； 8. 筛选前 3 个月内嗜酒者（1 天摄入的酒精量女性超过 15 g，男性超过 25 g [5 g 酒精 相当于 150 mL 啤酒、50 mL 葡萄酒或约 17 mL 低度白酒]，每周超过 2 次）或基 线期酒精呼气测试阳性者； 9. 筛选或给药前收缩压（SBP）：SBP ≥ 140 mmHg 或< 90 mmHg；舒张压（DBP）： DBP≥ 90 mmHg 或< 50 mmHg； 10. 筛选时谷草转氨酶（AST）或谷丙转氨酶（ALT）≥2 倍正常范围上限（ULN）， 或总胆红素≥1.5 倍 ULN； 11. 凝血功能异常且有临床意义者，或具有出血倾向或正在接受溶栓或抗凝治疗者， 或试验期间需接受预防抗凝治疗者； 12. 存在发生血栓栓塞事件风险者（如存在血栓栓塞病史、存在心血管疾病、糖尿病、 反复自发性流产、血脂异常）； 13. 筛选或给药前 12-导联心电图结果异常且有临床意义者（如：男性 QTcF>450 ms； 女性 QTcF>470 ms）； 14. 筛选期尿药筛查阳性者；或筛选前 2 年内有药物滥用史者； 15. 筛选期传染病筛查（包括乙肝病毒表面抗原、丙肝病毒抗体、人免疫缺陷病毒抗 体、梅毒抗体）阳性者； 16. 筛选前 4 周内或者计划在试验过程中接种活（减毒）疫苗者； 17. 筛选期或给药前 1 个月或药物 5 个半衰期内（以较长者为准）、或计划在试验期 间服用非本研究试验药物的任何处方药、非处方药或中草药等（偶尔使用推荐剂 量内的对乙酰氨基酚（一天用药总量不超过 2g，连续用药不超过三天）除外）） 或计划在试验期间服用任何营养补充剂者； 18. 筛选前 3 个月内参加过其他临床试验或在试验药物的 5 个半衰期内者（以接受过 试验药物或者医疗器械干预为准，以时间较长者为准）； 19. 既往任何时候接受过以下任一治疗： a) B 细胞靶向治疗（例如，利妥昔单抗、其 他抗 CD20 药物、抗 CD22[依帕珠单抗]、抗 CD52[阿仑珠单抗]、BLyS 受体融合 蛋白[BR3]、TACI-Fc）；b) 阿巴西普；c) CD40 或 CD40L 靶向治疗； 20. 经研究医生判定，任何有可能加大试验风险、影响受试者对方案依从性或影响受 试者完成试验的生理或者心理疾病或状况。

Exclusion criteria：

1. Subjects will be screened with a history, symptoms and test results suggestive of active or latent tuberculosis. Subjects will be screened by Interferon gamma release assay (IGRA) and frontal and lateral chest radiographs (X-rays). All subjects will be screened for TB status. Subjects who had an IGRA and X-ray within 1 month prior to screening were screened for TB based on the investigator's opinion. Subjects who have had an IGRA and X-ray within 1 month prior to screening may, at the investigator's discretion, not repeat the IGRA and X-ray at the time of screening; ? IGRA test results are not negative; ? If the IGRA result is inconclusive, retesting is permitted. Subjects with 2 inconclusive test results will be excluded from the study. Subjects with 2 indeterminate results will be excluded from the study; 2. previous history (within 5 years) of serious cardiovascular, hepatic, renal, gastrointestinal, psychoneurological, haematological or metabolic abnormalities. 2. prior history of serious cardiovascular, hepatic, renal, gastrointestinal, psychoneurological, haematological, metabolic abnormalities, etc; 3. have had a serious infection, serious trauma, or major surgical procedure within 6 months prior to screening or dosing; are scheduled to undergo surgery during the trial; or are scheduled to undergo surgery during the trial. (c) A history of metabolic abnormalities (within 5 years); 3; 4. chronic or recurrent infections requiring treatment within 12 months prior to screening; 5. have donated or lost ≥ 200 mL of blood within 1 month prior to screening or dosing, or ≥ 400 mL of blood within 3 months prior to dosing. Blood donation or loss within 1 month prior to screening or administration of the drug, or blood donation or loss within 3 months prior to administration of the drug, totalling ≥ 400 mL, or who have received a blood transfusion within 2 months; 6. a history of allergy to two or more dietary medications; or a known allergy to the study drug or any component of the study drug (see Annex 2 of the protocol for injectable components). (6. History of allergy to two or more dietary medications; or known allergy to the study drug or any component of the study drug (see Annex 2 of the protocol for injectable components) 7. a history of tobacco use, defined as an average of 5 or more cigarettes per day, within 3 months prior to screening; or an inability to comply with a smoking ban during the study; and 7. a history of tobacco use within 3 months prior to screening, defined as an average of more than 5 cigarettes per day, or inability to comply with a smoking ban during the study period 8. a history of alcohol use (intake of more than 15 g of alcohol per day for women and more than 25 g of alcohol per day for men [5 g alcohol (more than 15 g of alcohol for women and more than 25 g of alcohol for men in a day [5 g of alcohol equivalent to 150 mL of beer, 50 mL of wine, or approximately 17 mL of low proof liquor] more than twice a week) or a positive breath test for alcohol at baseline positive breath test for alcohol at baseline; 9. Systolic blood pressure (SBP) prior to screening or administration: SBP ≥ 140 mmHg or < 90 mmHg; diastolic blood pressure (DBP): DBP ≥ 90 mmHg or < 50 mmHg. 10; 10. ≥ 2 times the upper limit of the normal range (ULN) for alanine aminotransferase (AST) or alanine aminotransferase (ALT) at screening. or total bilirubin ≥ 1.5 times the ULN. 11; 11. persons with clinically significant coagulation abnormalities, or who have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy. or who require prophylactic anticoagulation during the trial; 12. individuals at risk for thromboembolic events (e.g., history of thromboembolism, cardiovascular disease, diabetes mellitus, (e.g., history of thromboembolic events, cardiovascular disease, diabetes mellitus, recurrent spontaneous abortions, dyslipidemia); 13. clinically significant abnormalities on 12-lead ECG prior to screening or dosing (e.g., QTcF >450 ms in men; (e.g., QTcF >450 ms in males; QTcF >470 ms in females); 14. individuals with a positive urine drug screen during the Screening Period; or a history of substance abuse within 2 years prior to Screening; 15. positive screening tests for infectious diseases (including hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and syphilis antibody) during the screening period; and (including Hepatitis B Virus Surface Antigen, Hepatitis C Virus Antibody, Human Immunodeficiency Virus Antibody, Syphilis Antibody) during the screening period 16. persons who have received a live (attenuated) vaccine within 4 weeks prior to screening or who plan to receive a live (attenuated) vaccine during the course of the trial; 17. who are taking a drug other than the investigational drug during the screening period or 1 month or 5 half-lives of the drug, whichever is longer, or who plan to take a drug other than the investigational drug during the trial; or Any prescription, over-the-counter, or herbal medicine that is not the study drug (occasional use of recommended doses of acetaminophen) during the screening period or within 1 month or 5 half-lives of the drug, whichever is longer or plan to take any prescription, over-the-counter, or herbal medication that is not the study trial medication during the trial (except for occasional use of acetaminophen in the recommended dosage (no more than 2 g total per day for up to three days in a row)) or who plan to take any nutritional supplements during the trial; 18. have participated in another clinical trial within 3 months prior to screening or are within 5 half-lives of the test drug (whichever is greater). intervention with the trial medication or medical device, whichever is longer); 19. Have received any of the following at any time: a) B-cell targeted therapy (e.g., rituximab, other anti-CD20 drugs, anti-CD20 drugs, anti-CD20 drugs, or other anti-CD20 drugs) other anti-CD20 drugs, anti-CD22 [eptalizumab], anti-CD52 [alemtuzumab], BLyS receptor fusion protein [BR3], and other B-cell targeted therapies) (b) Abatacept; c) CD40 or CD40L-targeted therapy as determined by the study physician; 20. any physical or psychological condition that, in the judgement of the investigating physician, is likely to increase the risk of the trial, interfere with the subject's adherence to the regimen, or affect the subject's ability to complete the trial. Any physical or psychological disease or condition that, as determined by the study physician, is likely to increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's ability to complete the trial.

研究实施时间：

Study execute time：

从 From 2023-07-14 00:00:00至 To 2026-07-14 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-07-14 00:00:00 至 To 2026-07-14 00:00:00

干预措施：

Interventions：

组别：

50 mg（iv）

样本量：

 5

Group：

50 mg(iv)

Sample size：

干预措施：

3例静脉给予SHR-2106,2例给予安慰剂

干预措施代码：

Intervention：

3 cases were given SHR-2106 intravenously, 2 cases were given placebo

Intervention code：

组别：

150 mg（iv）

样本量：

 5

Group：

150 mg(iv)

Sample size：

干预措施：

3例静脉给予SHR-2106,2例给予安慰剂

干预措施代码：

Intervention：

3 cases were given SHR-2106 intravenously, 2 cases were given placebo

Intervention code：

组别：

300 mg（iv）

样本量：

 8

Group：

300 mg(iv)

Sample size：

干预措施：

6例静脉给予SHR-2106,2例给予安慰剂

干预措施代码：

Intervention：

6 cases were given SHR-2106 intravenously, 2 cases were given placebo

Intervention code：

组别：

600 mg（iv）

样本量：

 8

Group：

600 mg(iv)

Sample size：

干预措施：

6例静脉给予SHR-2106,2例给予安慰剂

干预措施代码：

Intervention：

6 cases were given SHR-2106 intravenously, 2 cases were given placebo

Intervention code：

组别：

1200 mg（iv）

样本量：

 8

Group：

1200 mg(iv)

Sample size：

干预措施：

6例静脉给予SHR-2106,2例给予安慰剂

干预措施代码：

Intervention：

6 cases were given SHR-2106 intravenously, 2 cases were given placebo

Intervention code：

组别：

1800 mg（iv，可选）

样本量：

 8

Group：

1800 mg (iv, optional)

Sample size：

干预措施：

6例静脉给予SHR-2106,2例给予安慰剂

干预措施代码：

Intervention：

6 cases were given SHR-2106 intravenously, 2 cases were given placebo

Intervention code：

组别：

300 mg（sc）

样本量：

 8

Group：

300 mg(sc)

Sample size：

干预措施：

6例静脉给予SHR-2106,2例给予安慰剂

干预措施代码：

Intervention：

6 cases were given SHR-2106 intravenously, 2 cases were given placebo

Intervention code：

组别：

600 mg（sc，可选）

样本量：

 8

Group：

600 mg(sc,optional)

Sample size：

干预措施：

6例静脉给予SHR-2106,2例给予安慰剂

干预措施代码：

Intervention：

6 cases were given SHR-2106 intravenously, 2 cases were given placebo

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：

 三甲 

Institution
hospital：

Third Xiangya Hospital, Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

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：

十二导联心电图

指标类型：

主要指标

Outcome：

Twelve-lead 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：

实验室检查

指标类型：

主要指标

Outcome：

laboratory test

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 event

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

妊娠检测

指标类型：

主要指标

Outcome：

Pregnancy Tests

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血浆浓度

指标类型：

主要指标

Outcome：

Plasma concentration

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从 0 至最后可测浓度的血浆浓 度-时间曲线下面积AUC0-t

指标类型：

主要指标

Outcome：

AUC0-t

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从 0 至无穷大时间点的血浆浓 度-时间曲线下面积AUC0-inf

指标类型：

主要指标

Outcome：

AUC0-inf

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

峰浓度

指标类型：

主要指标

Outcome：

Cmax

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

达峰时间

指标类型：

主要指标

Outcome：

Tmax

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

半衰期

指标类型：

主要指标

Outcome：

t?

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

清除率

指标类型：

主要指标

Outcome：

CL( CL/F)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

分布容积

指标类型：

主要指标

Outcome：

Vss( Vz/F)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

ADA 的发生率

指标类型：

主要指标

Outcome：

Incidence of ADA

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

外周血中 B 细胞表面 CD40 受体占有率

指标类型：

主要指标

Outcome：

CD40 receptor occupancy on the surface of B cells in peripheral blood

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：

血样

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：

尿样

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：

粪样

组织：

Sample Name：

fecal sample

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 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）：

本研究采用区组随机化方法。每个剂量组的前两例受试者，按照 1:1 的比例分配到 2个组别（分别为 SHR-2106 组 1 例和安慰剂组 1 例）；低剂量组（50 mg 和 150 mg）剩余受试者按照2：1的比例随机分配到2个组别（分别为SHR-2106组2例和安慰剂组1例）；其余剂量组（300 mg ~ 1800 mg）剩余受试者按照 5：1 的比例随机分配到 2 个组别（分别为 SHR-2106 组 5 例和安慰剂组 1 例）。随机化专员采用统计软件完成随机分配表与药物编号表的产生，中央随机化系统对符合随机标准的受试者进行随机分组，并根据入组结果给予受试者相应组别的药物

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

This study used block group randomisation. The first two subjects in each dose group were assigned to 2 groups in a 1:1 ratio (1 case in the SHR-2106 group and 1 case in the placebo group, respectively); the remaining subjects in the low dose group (50 mg and 150 mg) were randomly assigned to 2 groups in a 2:1 ratio (2 cases in the SHR-2106 group and 1 case in the placebo group, respectively); and the remaining subjects in the remaining dose group (300 mg ~ 1800 mg) remaining subjects were randomly assigned to 2 groups (5 cases in the SHR-2106 group and 1 case in the placebo group, respectively) in a 5:1 ratio. The randomisation specialist used statistical software to complete the generation of the random allocation table and the drug numbering table. The central randomisation system randomised the subjects who met the randomisation criteria into groups and gave them the drugs in the corresponding groups according to the results of the enrolment.

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：

从随机数字的产生、试验用药品的编码、受试者入组用药、研究结果的记录和评价、研究过程的检查至数据管理以及数据库锁定，都必须保持盲态。盲底分别保存在编盲人员和随机化系统中。受试者、研究者、所有参与试验或临床评定的医务人员、参与本试验的监查员、医学经理、安全经理、统计师、医学总监等以及第三方合同试验机构相关人员对受试者接受何种试验用药品均不知情。申办方药理学家以及必要的相关人员为非盲状态以便实时跟进安全性和药代动力学参数的关系，以及为药物爬坡做潜在的剂量调整提供必要的信息。

Blinding：

From the generation of randomised numbers, coding of trial drugs, enrolment of subjects for medication, recording and evaluation of study results, checking of the study process to data management and database locking, blinding must be maintained. Blind bottoms are kept separately in the blinded personnel and in the randomisation system. Subjects, investigators, all medical staff involved in the trial or in clinical evaluation, the Supervisor, Medical Manager, Safety Manager, Statistician, Medical Director, etc., as well as those involved in third-party contract trial organisations, will have a clear understanding of the trial medication received by the subject. The sponsor's pharmacologist and necessary personnel will be unblinded in order to allow real-time follow-up of the relationship between safety and pharmacokinetic parameters and to provide the information necessary for potential dose adjustments for ramp-up. information for potential dose adjustments for drug ramping.

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：

电子病例报告表（eCRF）的填写:eCRF 由研究者或数据录入人员通过 EDC 系统进行填写。eCRF 应当及时填写，并确保填写的数据可以从原始记录中被溯源。数据递交之后在 EDC 中进行的数据修改，需按照系统提示，填写数据修改的原因。修改履历和修改原因会被记录在 EDC 系统的稽查轨迹中。研究者或其授权的人员需要对 eCRF 数据的真实性、完整性和及时性进行确认，并在 EDC 系统中进行电子签名。 电子数据采集系统（EDC）的使用:EDC 系统在首例受试者入组前需启动上线使用。所有 EDC 用户需完成相关培训并归档培训记录，才能获得访问本研究 eCRF 的权限。当用户在 eCRF 上实施电子签名时，需要确认并同意电子签名的使用声明。账户仅限于用户本人使用，密码需要妥善保管并定期更换。研究团队有人员变更时，权限需要及时注销。

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

Completion of the electronic case report form (eCRF): The eCRF is completed by the investigator or data entry staff through the EDC system. eCRFs should be completed in a timely manner and ensure that the data can be traced back from the original record. Data changes made in EDC after data submission should be accompanied by the reason for the change, as prompted by the system. The revision history and the reason for the revision will be recorded in the audit trail of the EDC system. The researcher or his/her authorised personnel need to confirm the authenticity, completeness and timeliness of the eCRF data and sign electronically in the EDC system. Electronic Data Capture (EDC) System Use:The EDC system needs to be activated for on-line use prior to enrolment of the first subject. All EDC users will be required to complete and document training before they are granted access to the study's eCRF. Users will be required to acknowledge and agree to the Statement of Use of Electronic Signatures when implementing electronic signatures on the eCRF. Accounts are for the sole use of the user, and passwords need to be kept secure and changed regularly. Permissions need to be cancelled when there is a change of personnel in the research team.

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：

  2023-07-14 11:10:57