ChiCTR2600124133 版本V1.0 版本创建时间2026/05/07 17:32:46 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：

 ChiCTR2600124133 

最近更新日期：

Date of Last Refreshed on：

 2026-05-07 17:32:30 

注册时间：

Date of Registration：

 2026-05-07 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

一项评价CCIBPR01005在健康成年男性受试者中单次给药的安全性、耐受性、药代动力学、药效学和免疫原性的随机、双盲、安慰剂对照的Ⅰa期临床研究

Public title：

A randomized, double-blind, placebo-controlled phase Ia clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of CCIBPR01005 in healthy adult male subjects

注册题目简写：

一项评估健康男性受试者单次注射CCIBPR01005后的安全性、耐受性、药代动力学、药效学和免疫原性的Ⅰa期临床研究

English Acronym：

A Phase Ia clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single injection of CCIBPR01005 in healthy male subjects

研究课题的正式科学名称：

一项评价CCIBPR01005在健康成年男性受试者中单次给药的安全性、耐受性、药代动力学、药效学和免疫原性的随机、双盲、安慰剂对照的Ⅰa期临床研究

Scientific title：

A randomized, double-blind, placebo-controlled phase Ia clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of CCIBPR01005 in healthy adult male 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：

郭雪 

研究负责人：

陈建 

Applicant：

Guo Xue 

Study leader：

Chen Jian 

申请注册联系人电话：

Applicant telephone：

 +86 136 4441 4610

研究负责人电话：

Study leader's
telephone：

+86 135 8808 4969

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：

 guoxue@sinopharm.com

研究负责人电子邮件：

Study leader's E-mail：

 cj21_0503@163.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：

吉林省长春市高新区创新路1616号

研究负责人通讯地址：

浙江省-杭州市-萧山区育才北路728号

Applicant address：

1616 Chuangxin Road, Gaoxin District, Changchun, Jilin

Study leader's address：

No. 728 Yucai North Road, Xiaoshan District, Hangzhou City, Zhejiang 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：

长春生物制品研究所有限责任公司

Applicant's institution：

Changchun Institute of Biological Products Co., Ltd

研究负责人所在单位：

浙江萧山医院

Affiliation of the Leader：

Zhejiang Xiaoshan Hospital

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：

 EC-MED-2025047

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：

浙江萧山医院药物临床试验伦理委员会

Name of the ethic committee：

Zhejiang Xiaoshan Hospital Drug Clinical Trial Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-06-10 00:00:00

伦理委员会联系人：

徐赛楠

Contact Name of the ethic committee：

Xu Sainan

伦理委员会联系地址：

杭州市萧山区育才北路728号浙江萧山医院5号楼4楼

Contact Address of the ethic committee：

4th Floor, Building 5, Zhejiang Xiaoshan Hospital, 728 Yucai North Road, Xiaoshan District, Hangzhou City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 571 8220 1925

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：

浙江萧山医院

Primary sponsor：

Zhejiang Xiaoshan Hospital

研究实施负责（组长）单位地址：

杭州市萧山区育才北路728号浙江萧山医院

Primary sponsor's address：

No. 728 Yucai North Road, Xiaoshan District, Hangzhou City, Zhejiang Xiaoshan Hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

吉林省

市(区县)：

长春市

Country：

China

Province：

Jilin

City：

Changchun

单位(医院)：

长春生物制品研究所有限责任公司

具体地址：

长春市高新区创新路1616号

Institution
hospital：

Changchun Institute of Biological Products Co., Ltd

Address：

1616 Chuangxin Road, Gaoxin District, Changchun, Jilin

经费或物资来源：

自筹

Source(s) of funding：

self-raised

研究疾病：

因内源性生长激素缺乏所导致的儿童生长缓慢（儿童GHD）  

Target disease：

Slow growth in children due to endogenous growth hormone deficiency (GHD)

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：

主要目的：评价人生长激素-Fc融合蛋白注射液在健康成年男性受试者单次皮下注射后的安全性和耐受性。 次要目的：评价人生长激素-Fc融合蛋白注射液在健康成年男性受试者单次皮下注射后的药代动力学（PK）特征。 评价人生长激素-Fc融合蛋白注射液在健康成年男性受试者单次皮下注射后的药效动力学（PD）特征。 评价人生长激素-Fc融合蛋白注射液在健康成年男性受试者单次皮下注射后的免疫原性。  

Objectives of Study：

Main objective: To evaluate the safety and tolerability of human growth hormone Fc fusion protein injection after a single subcutaneous injection in healthy adult male subjects. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of human growth hormone Fc fusion protein injection after a single subcutaneous injection in healthy adult male subjects. Evaluate the pharmacokinetic (PD) characteristics of human growth hormone Fc fusion protein injection after a single subcutaneous injection in healthy adult male subjects. Evaluate the immunogenicity of human growth hormone Fc fusion protein injection after a single subcutaneous injection in healthy adult male 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. 受试者必须在试验前对本研究知情同意、并对试验内容、过程及可能出现的不良反应充分了解，并自愿签署书面的ICF； 2. 年龄在18～45周岁的健康男性受试者（包括18和45周岁）； 3. 男性受试者不低于50公斤，体重指数（BMI）在19～26.0 kg/m^2范围内（包括边界值）［BMI=体重（kg）/身高^2（m^2）］； 4. 从签署ICF开始至末次给药后的3个月内受试者（包括伴侣）必须愿意使用医学上可接受的避孕方法（如避孕套或宫内节育器等）； 5. 受试者能够与研究者作良好的沟通并能够依照方案规定完成研究。

Inclusion criteria

1. Participants must give informed consent to the study before the trial, fully understand the content, process, and potential adverse reactions of the trial, and voluntarily sign a written ICF; 2. healthy male subjects aged 18 to 45 years old (including 18 and 45 years old); 3. male subjects weighing no less than 50 kilograms, with a body mass index (BMI) within the range of 19-26.0 kg/m^2 (including boundary values) [BMI=weight (kg)/height ^2 (m^2)]; 4. From the signing of the ICF until 3 months after the last administration, subjects (including partners) must be willing to use medically acceptable contraceptive methods (such as condoms or intrauterine devices); 5. The subjects are able to communicate well with the researchers and complete the study according to the protocol.

排除标准：

1. 有食物、药物过敏史，包括已知对试验药或生长激素类药物或任何辅料有过敏史者； 2. 研究者认为具有临床意义的肺、肝、肾、内分泌、心脑血管、神经、精神、胃肠道（如消化性溃疡病）、肿瘤（有垂体瘤、脑膜瘤等颅内肿瘤史者；活动性恶性肿瘤患者；既往恶性肿瘤病史者）、免疫、皮肤、血液或代谢紊乱等疾病或任何其他疾病，或具有这些疾病的病史，或将危害受试者的安全或影响研究结果的因素； 3. 有糖尿病病史或在筛选时发现糖代谢指标大于正常值上限（ULN）； 4. 研究者认为具有临床意义的甲状腺疾病史或在筛选时甲状腺功能检查结果异常且有临床意义； 5. 体格检查、生命体征、实验室检查（血常规、凝血功能、血生化、尿常规等）、激素检测、12导联心电图等检查结果异常，并且经研究者判断异常有临床意义； 6. 血清病毒学检查结果阳性，或当前结果异常有临床意义：乙肝表面抗原、丙肝抗体、人类免疫缺陷病毒p24抗原/抗体、梅毒螺旋体抗体； 7. 经询问既往有眼底病变（视神经乳头水肿病变）病史者； 8. 给药前3个月内存在严重感染或给药前7天内存在感染症状，经研究者判断不适合参加者； 9. 给药前2周至研究用药前发生急性疾病或有伴随用药； 10. 给药前2年内具有药物滥用史或药物滥用筛查阳性，或习惯性服用任何药物，包括中草药； 11. 给药前3个月内过量吸烟（≥5支/天）或研究用药前48 h内吸烟或试验期间不能中断吸烟； 12. 给药前3个月内存在酒精滥用史或酗酒史，或研究用药前48 h内饮酒或给药前酒精检测结果阳性且试验期间不能中断饮酒者。酗酒的定义为：每周饮用14个单位以上的酒精饮料（1单位=啤酒285ml，或烈酒25ml，或葡萄酒100ml）； 13. 给药前90天内参加过任何药物或医疗器械临床试验者（未使用干预性药物或试验用医疗器械的除外）； 14. 给药前3个月内接种疫苗； 15. 给药前3个月内献血或大量失血（≥400ml）、接受过输血或使用过血液制品者； 16. 给药前14天内使用了任何处方药、非处方药、保健品或中草药等；或使用了长效注射剂或植入剂； 17. 在研究给药前48 h内摄入任何含有咖啡因或黄嘌呤成分的食物或饮料（如：咖啡、浓茶、可乐、巧克力等），或食用了动物血制品（如鸭血），或食用了含有火龙果、葡萄柚、芒果成分的食物或饮料，或有剧烈运动，或试验期间不能中断以上饮食或剧烈运动者； 18. 给药前4周内接受过重大手术（重大手术的定义参照2022年12月6日国家卫健委发布的《医疗机构手术分级管理办法》中规定的3级和4级手术）或研究期间计划进行重大手术者； 19. 对饮食有特殊要求，不能遵守统一饮食； 20. 有晕针或晕血史，或采血困难者； 21. 有凝血功能障碍者； 22. 研究者认为任何不适宜受试者进入本项试验的其它因素。

Exclusion criteria：

1. Individuals with a history of food or drug allergies, including those known to have allergies to investigational drugs, growth hormone drugs, or any excipients; 2. Researchers consider clinically significant diseases such as lung, liver, kidney, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal (such as peptic ulcer disease), tumors (those with a history of intracranial tumors such as pituitary tumors and meningiomas; active malignant tumor patients; those with a history of previous malignant tumors), immune, skin, blood, or metabolic disorders, or any other diseases, or factors with a history of these diseases that may endanger the safety of subjects or affect research results; 3. Have a history of diabetes or find that the glucose metabolism index is greater than the upper limit of normal value (ULN) during screening; 4. Researchers believe that a history of thyroid disease with clinical significance or abnormal thyroid function test results during screening have clinical significance; 5. Abnormal results in physical examination, vital signs, laboratory tests (blood routine, coagulation function, blood biochemistry, urine routine, etc.), hormone testing, 12 lead electrocardiogram, etc., and judged by researchers to have clinical significance; 6. The result of serum virology test is positive, or the current result is abnormal and has clinical significance: hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus p24 antigen/antibody, treponema pallidum antibody; 7. Inquire about individuals with a history of retinal lesions (optic nerve papilledema); If there is a severe infection within 3 months before administration or symptoms of infection within 7 days before administration, and the researcher determines that it is not suitable for the participant; 8. Acute illness or concomitant medication occurred 2 weeks before administration to the study medication; 9. Within 2 years prior to administration, there is a history of drug abuse or a positive drug abuse screening result, or habitual use of any medication, including Chinese herbal medicine; 11. Smoking excessively (>= 5 cigarettes/day) within 3 months before administration, or smoking within 48 hours before study medication, or smoking should not be interrupted during the trial period; 12. Individuals who have a history of alcohol abuse or alcoholism within the past 3 months prior to drug administration, or who have consumed alcohol within 48 hours prior to drug administration or tested positive for alcohol before drug administration and cannot interrupt drinking during the trial period. The definition of alcoholism is: drinking more than 14 units of alcoholic beverages per week (1 unit=285ml of beer, 25ml of spirits, or 100ml of wine); 13. Individuals who have participated in any drug or medical device clinical trials within 90 days prior to administration (excluding those who have not used intervention drugs or experimental medical devices); 14. Vaccination should be administered within 3 months prior to administration; 15. Individuals who have donated blood or experienced significant blood loss (>= 400ml), received blood transfusions, or used blood products within 3 months prior to medication administration; 16. Within 14 days prior to administration, any prescription drugs, over-the-counter drugs, health supplements, or Chinese herbal medicines were used; Or using long-acting injections or implants; 17. Individuals who consume any food or beverage containing caffeine or xanthine components (such as coffee, strong tea, cola, chocolate, etc.), or consume animal blood products (such as duck blood), or consume food or beverages containing dragon fruit, grapefruit, mango components, or engage in vigorous exercise within 48 hours prior to study administration, or who cannot interrupt the above diet or vigorous exercise during the trial period; 18. Individuals who have undergone major surgery (defined as Level 3 and Level 4 surgery according to the "Management Measures for Surgical Grading in Medical Institutions" issued by the National Health Commission on December 6, 2022) or plan to undergo major surgery during the study period within 4 weeks prior to drug administration; 19. have special dietary requirements and cannot adhere to a uniform diet; 20. individuals with a history of needle or blood dizziness, or difficulty in blood collection; 21. individuals with coagulation dysfunction; 22. Researchers believe that there are any other factors that are not suitable for participants to enter this trial.

研究实施时间：

Study execute time：

从 From 2025-06-26 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-26 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：

组1

样本量：

 10

Group：

Group 1

Sample size：

干预措施：

0.16mg/kg CCIBPR01005/安慰剂 单次给药 皮下注射

干预措施代码：

Intervention：

0.16mg/kg CCIBPR01005/placebo single dose subcutaneous injection

Intervention code：

组别：

组2

样本量：

 10

Group：

Group 2

Sample size：

干预措施：

0.4mg/kg CCIBPR01005/安慰剂 单次给药 皮下注射

干预措施代码：

Intervention：

0.4mg/kg CCIBPR01005/placebo single dose subcutaneous injection

Intervention code：

组别：

组3

样本量：

 10

Group：

Group 3

Sample size：

干预措施：

0.8mg/kg CCIBPR01005/安慰剂 单次给药 皮下注射

干预措施代码：

Intervention：

0.8mg/kg CCIBPR01005/placebo single dose subcutaneous injection

Intervention code：

组别：

组4

样本量：

 10

Group：

Group 4

Sample size：

干预措施：

1.2mg/kg CCIBPR01005/安慰剂 单次给药 皮下注射

干预措施代码：

Intervention：

1.2mg/kg CCIBPR01005/placebo single dose subcutaneous injection

Intervention code：

组别：

组5

样本量：

 10

Group：

Group 5

Sample size：

干预措施：

1.6mg/kg CCIBPR01005/安慰剂 单次给药 皮下注射

干预措施代码：

Intervention：

1.6mg/kg CCIBPR01005/placebo single dose subcutaneous injection

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

 杭州市 

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

 浙江萧山医院 

单位级别：

 三乙 

Institution
hospital：

Zhejiang Xiaoshan Hospital

Level of the institution：

Tertiary B

测量指标：

Outcomes：

指标中文名：

安全性及耐受性

指标类型：

主要指标

Outcome：

Safety and Tolerability

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药代动力学（PK）特征

指标类型：

主要指标

Outcome：

Pharmacokinetic (PK) Characteristics

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（PD）指标

指标类型：

次要指标

Outcome：

Pharmacodynamic (PD) index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

免疫原性

指标类型：

次要指标

Outcome：

Immunogenicity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

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 45 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

受试者的随机号及药物编号由非盲统计师产生，非盲统计师将提供一份详细的随机方案，并采用SAS 9.4 或以上版本产生随机表。

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

The random number and drug number of the subjects will be generated by a non blinded statistician, who will provide a detailed randomization plan and generate a randomization table using SAS 9.4 or higher version.

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：

本次试验使用双盲设计，即研究者和受试者均不知道受试者所属的治疗组。试验药物和安慰剂进行统一外包装，按照相应的随机分组结果进行编号。设盲过程应有文字记录并由设盲所有人员签字，盲底在药物分装后必须当场密封并由非盲统计师或指定的编盲人员签字。盲底由非盲统计师导入本研究使用的IWRS：Clinflash-IRT系统，电子版盲底将由非盲统计师保存在限制性文件夹中，临床研究参与人员对于受试者随机分配表处于盲态。

Blinding：

This experiment used a double-blind design, where neither the researcher nor the subjects knew which treatment group the subjects belonged to. The experimental drug and placebo are packaged uniformly and numbered according to the corresponding random grouping results. The blinding process should be documented in writing and signed by all personnel responsible for blinding. The blinding background must be sealed on the spot after drug packaging and signed by a non blinded statistician or designated blinding personnel. The blind background will be imported into the IWRS: Clinflash IRT system used in this study by a non blinded statistician, and the electronic version of the blind background will be saved in a restricted folder by the non blinded statistician. Clinical study participants will be blinded to the subject randomization table.

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）：

本临床试验正在进行中，且后续还要继续开展Ib期临床试验，原始数据不方便透露，故原始数据暂不共享。

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

This clinical trial is currently underway, and phase Ib clinical trials will continue to be conducted in the future. The raw data is not convenient to disclose, so it will not be shared temporarily.

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：

电子数据采集和管理系统

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：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-05-07 17:32:30