ChiCTR2300068047 版本V1.0 版本创建时间2023/02/05 19:56:28 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：

 ChiCTR2300068047 

最近更新日期：

Date of Last Refreshed on：

 2023-02-05 19:56:20 

注册时间：

Date of Registration：

 2023-02-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

在健康受试者中评价BA2101单次皮下注射的安全性、耐受性、药代动力学、药效学及免疫原性的随机、双盲、安慰剂对照、剂量递增的Ⅰ期临床研究

Public title：

A randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of BA2101 as a single subcutaneous injection in healthy subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

在健康受试者中评价BA2101单次皮下注射的安全性、耐受性、药代动力学、药效学及免疫原性的随机、双盲、安慰剂对照、剂量递增的Ⅰ期临床研究

Scientific title：

A randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of BA2101 as a single subcutaneous injection 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：

黄欣 

研究负责人：

阳国平 

Applicant：

Xin Huang 

Study leader：

Guoping Yang 

申请注册联系人电话：

Applicant telephone：

 19307412147

研究负责人电话：

Study leader's
telephone：

073189918665

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：

 2401808686@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：

长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

长沙市岳麓区桐梓坡路138号

Applicant address：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

Study leader's address：

138 Tongzibo 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

Applicant's institution：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

研究负责人所在单位：

中南大学湘雅三医院

Affiliation of the Leader：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

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22412

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：

Ethics Committee of the Third Xiangya Hospital of Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-10-11 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

Contact Address of the ethic committee：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 88618938

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：

湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

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：

Hu'nan

City：

Changsha

单位(医院)：

中南大学湘雅三医院临床试验中心

具体地址：

湖南省长沙市岳麓区桐梓坡路138号

Institution
hospital：

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

Address：

138 Tongzibo Road, Yuelu District, Changsha, Hu'nan

经费或物资来源：

山东博安生物技术股份有限公司

Source(s) of funding：

Shandong Boan Biotechnology Co.

研究疾病：

中重度特应性皮炎  

Target disease：

Moderate-to-severe atopic dermatitis

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：

不同剂量对照 

Study design：

Dose comparison 

研究目的：

主要目的：在健康受试者中评价 BA2101 单次皮下注射的安全性和耐受性。 次要目的：在健康受试者中评价 BA2101 单次皮下注射的 PK、PD 及免疫原性。  

Objectives of Study：

Primary objective: to evaluate the safety and tolerability of BA2101 as a single subcutaneous injection in healthy subjects. The safety and tolerability of BA2101 single subcutaneous injection were evaluated in healthy subjects. Secondary objective: To evaluate the PK, PD and immunogenicity of BA2101 in healthy subjects with a single subcutaneous injection. PD and immunogenicity 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：

符合全部下列标准的受试者方可入选本研究：
1. 受试者自愿签署书面的知情同意书；
2. 健康男性或女性，年龄18～45周岁（包括边界值）；
3. 男性体重≥50kg，女性体重≥45kg，且体重指数（BMI）19.0kg/m2≤BMI≤26.0 kg/m2；
4. 生命体征、体格检查、实验室检查、12导联心电图、正侧位胸片等无异常或研究者认为异常无临床意义者；
5. 筛选时，没有接受过手术绝育的育龄女性或绝经后不到1年的女性血妊娠试验结果为阴性。男性和育龄女性受试者同意至少在筛选前2周至试验用药后6个月内采取有效避孕措施（禁止使用避孕药）。

Inclusion criteria

Subjects were enrolled in this study if they met all of the following criteria.
1. voluntary written informed consent signed by the subject.
2. healthy males or females, aged 18 to 45 years (including borderline values).
3. males weighing ≥ 50 kg and females weighing ≥ 45 kg with a body mass index (BMI) of 19.0 kg/m2 ≤BMI≤26.0 kg/m2 .
4. no abnormalities in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, frontal and lateral chest No abnormalities in vital signs, physical examination, laboratory tests, 12-lead ECG, or orthopantomogram, or those whose abnormalities were not considered clinically significant by the investigator
5. women of childbearing age who have not undergone surgical sterilization or who are less than 1 year post-menopausal at the time of screening Women with negative blood pregnancy test results. Male and female subjects of childbearing potential agree to a minimum of Use effective contraception from 2 weeks prior to screening to 6 months after trial dosing (contraceptive use is prohibited). The use of contraceptive pills is prohibited).

排除标准：

符合下列任一标准的受试者，不得入选本研究：
1. 既往或目前正患有循环系统、内分泌系统、神经系统、消化系
统、呼吸系统、泌尿生殖系统、血液学、免疫学、精神病学、
皮肤病学、眼科及代谢异常等任何临床严重疾病者或能干扰试
验结果的任何其他疾病；
2. 目前患有口腔疱疹者；
3. 有新型冠状病毒感染病史者；
4. 存在寄生虫侵染史或最近（6个月内）前往过寄生虫流行区；
5. 已知对试验用药品的任何组分或类似药物有过敏史者，或为过
敏体质者（既往对两种或两种以上食物或药物或其他物品过敏
者）；有哮喘既往病史；
6. 经询问，有晕血或晕针史者，不能耐受静脉穿刺者；
7. 乙肝表面抗原（HBsAg），丙型肝炎抗体测定（HCV-AB）、人
免疫缺陷病毒抗原抗体初筛（HIVAg/Ab）、梅毒螺旋体特异抗
体（TP）任一检测结果阳性者；
8. 签署知情同意前4周内接受过重大外科手术，或计划在研究期
间进行外科手术者；
9. 签署知情同意前14天内服用过任何药物或保健品者（包括中草
药）；
10. 签署知情同意前3个月内接种过活疫苗或减毒活疫苗，或在研
究期间和研究后3个月内计划接种活疫苗或减毒活疫苗；签署
知情同意前3个月内系统应用免疫抑制剂；签署知情同意前接
受过生物制剂（抗体或其衍生物）治疗，用药结束未满5个半衰
期者；
11. 签署知情同意前3个月内参加任何临床试验且使用了任何临床
试验药物者；
12. 签署知情同意前3个月内献血或大量失血（≥200 mL，不包括女
性月经期失血）、接受输血或使用血制品者；
13. 妊娠或哺乳期妇女，以及试验期间不能采用一种或一种以上的
非药物避孕措施者；
14. 对饮食有特殊要求，不能遵守统一饮食者；
15. 嗜烟者或签署知情同意前3个月每日吸烟量多于5支者或试验
期间不能停止使用任何烟草类产品者；
16. 酗酒者或签署知情同意前3个月内经常饮酒者，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）或试验期间不能停止使用任何含酒精产品
者，或酒精呼气测试阳性者；
17. 药物滥用者或签署知情同意前3个月使用过软毒品（如：大麻）
或签署知情同意前1年服用硬毒品（如：可卡因、苯环己哌啶
等）者，或者药物滥用筛查结果阳性者；
18. 受试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：

Subjects who meet any of the following criteria are not eligible for enrollment in this study.
1. previous or current circulatory, endocrine, neurological, gastrointestinal
system, respiratory system, genitourinary system, hematology, immunology, psychiatry
dermatology, ophthalmology, and metabolic abnormalities or any other disease that could interfere with the test results.
Any other disease that can interfere with the test results.
2. persons currently suffering from oral herpes
3. a history of novel coronavirus infection
4. a history of parasitic infestation or recent travel (within 6 months) to a parasitic endemic area.
5. a known history of allergy to any component of the test drug or similar drug, or an allergic person (previous allergic reaction)
Allergy (previous allergy to two or more foods or medications or other items)
(previous allergy to two or more foods or drugs or other items); a past history of asthma.
6. those who, upon inquiry, have a history of blood or needle sickness and cannot tolerate venipuncture.
7. hepatitis B surface antigen (HBsAg), hepatitis C antibody assay (HCV-AB), human
Immunodeficiency virus antigen antibody primary screening (HIVAg/Ab), syphilis spirochete specific antibody (TP)
(TP) with positive results for any of these tests.
8. have undergone major surgical procedures within 4 weeks prior to signing informed consent, or are scheduled to undergo surgical procedures during the study period
8. have undergone major surgical procedures within 4 weeks prior to signing informed consent, or are planning to undergo surgical procedures during the study period
9. have taken any medications or supplements (including Chinese herbs) within 14 days prior to signing informed consent
medicine) within 14 days prior to signing informed consent.
10. have received a live or live attenuated vaccine within 3 months prior to signing informed consent, or have received a live or live attenuated vaccine within 3 months of signing informed consent, or have received a live vaccine within 3 months of signing informed consent.
10. have received a live or live attenuated vaccine within 3 months prior to signing informed consent, or are scheduled to receive a live or live attenuated vaccine during and within 3 months after the study; and
systemic immunosuppression within 3 months prior to signing informed consent; received a biologic agent (antibody or its derivative) prior to signing informed consent
received a biologic agent (antibody or its derivative) prior to signing the informed consent and had not completed 5 half-lives
11.
11. participated in any clinical trial and used any clinical trial drug within 3 months prior to signing informed consent
11. those who participated in any clinical trial and used any clinical trial drug within 3 months prior to signing informed consent
12. donated blood or lost a significant amount of blood (≥200 mL, excluding female blood loss during menstruation) within 3 months prior to signing informed consent
12. donated blood or lost a significant amount of blood (≥200 mL, excluding menstrual blood loss in women), received a blood transfusion or used blood products within 3 months prior to signing informed consent
13. women who are pregnant or breastfeeding, and who are unable to use one or more non-pharmaceutical contraceptive measures during the trial
non-pharmaceutical contraceptive measures during the trial.
14. persons with special dietary requirements who are unable to comply with a uniform diet
15. smokers or smokers who smoked more than 5 cigarettes per day in the 3 months prior to signing informed consent or who cannot stop using any tobacco products during the trial
Those who cannot stop using any tobacco products during the trial period.
16. alcoholics or regular drinkers in the 3 months prior to signing informed consent, i.e., those who consume more than 14 units of alcohol per week (1 unit = 1 unit of alcohol).
Alcoholic or regular drinker within 3 months prior to signing informed consent, i.e., consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine) or
or 150 mL of wine) per week or cannot stop using any alcohol-containing product during the trial, or have a positive breath test for alcohol.
17. a person who is a substance abuser or has signed an informed consent form
17. substance abusers or those who have used soft drugs (e.g., marijuana) in the 3 months prior to signing informed consent
or hard drugs (e.g., cocaine, phencyclidine) in the 1 year prior to signing informed consent, or
etc.), or who have a positive drug abuse screening result.
18. subjects who may be unable to complete the study for other reasons or who, in the opinion of the investigator, should not be
18. subjects who may be unable to complete the study for other reasons or who the investigator believes should not be included.

研究实施时间：

Study execute time：

从 From 2023-02-03 00:00:00至 To 2025-02-09 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-02-03 00:00:00 至 To 2025-02-03 00:00:00

干预措施：

Interventions：

组别：

75mg组

样本量：

 3

Group：

75mg group

Sample size：

干预措施：

接受试验药物

干预措施代码：

Intervention：

Receiving trial drugs

Intervention code：

组别：

150 mg组

样本量：

 10

Group：

150 mg group

Sample size：

干预措施：

8例接受试验药物，2 例接受安慰剂

干预措施代码：

Intervention：

8 cases received the trial drug, 2 cases received placebo

Intervention code：

组别：

300 mg组

样本量：

 10

Group：

300 mg group

Sample size：

干预措施：

8例接受试验药物，2 例接受安慰剂

干预措施代码：

Intervention：

8 cases received the trial drug, 2 cases received placebo

Intervention code：

组别：

450 mg组

样本量：

 10

Group：

450 mg group

Sample size：

干预措施：

8例接受试验药物，2 例接受安慰剂

干预措施代码：

Intervention：

8 cases received the trial drug, 2 cases received placebo

Intervention code：

组别：

600mg组

样本量：

 10

Group：

600mg group

Sample size：

干预措施：

8例接受试验药物，2 例接受安慰剂

干预措施代码：

Intervention：

8 cases received the trial drug, 2 cases received 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)：

 长沙 

Country：

China

Province：

Hu'nan

City：

Changsha

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三级甲等 

Institution
hospital：

The Third Xiangya Hospital of 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：

实验室检查

指标类型：

主要指标

Outcome：

Laboratory 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：

12 导联心电图

指标类型：

主要指标

Outcome：

12-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：

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：

指标中文名：

抗药抗体

指标类型：

主要指标

Outcome：

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：

中和抗体

指标类型：

主要指标

Outcome：

Nab

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血药浓度

指标类型：

主要指标

Outcome：

Blood concentration

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：

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：

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）：

将采用交互式网页应答系统（Interactive Web Response System, IWRS）进行随机。非盲统计师通过 SAS 9.4 统计软件，采用区组随机化法产生随机分配表并将随机分配表上载到 IWRS 中。随机分配表应具有重现性，所设定的种子数、区组长度等参数均需要妥善保存。参加本试验的研究者在筛选出每一例合格的受试者后，将登陆 IWRS，获取该受试者所对应的随机号和药物编号。受试者的随机编号是唯一的，且在整个临床期间不会改变。因任何原因、不论是否是给予了试验用药品的退出或被撤出临床试验的随机化受试者，将保留其随机化编号，该受试者将不被允许再次进入本试验。

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

The Interactive Web Response System (IWRS) will be used for Randomization. The non-blinded statistician will use SAS 9.4 statistical software to generate a random assignment table using the block group randomization method and The random assignment table was uploaded into the IWRS. The random assignment table shoul

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：

Blinding：

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）：

文章发表

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

Article Publication

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：

采用纸质 CRF：本次试验采用纸质 CRF 采集数据。 1.纸质 CRF 对应的数据管理大致流程：CRC 填写纸质 CRF（pCRF）；监查员进行现场核查（SDV）；数据疑问和解答：研究者根据疑问进行解答并在答疑表中签字确认。该过程如此反复，直到疑问被全部解决，数据清洁。 2.医学编码：不良事件采用 MedDRA V22.0 或更高版本字典进行编码，合并用药采用 WHO ATC进行分类。

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

Use of paper CRF: This trial used paper CRF to collect data. 1. Paper CRF corresponds to the general process of data management: CRC fills in the paper CRF (pCRF); the supervisor performs the site verification (SDV); data queries and answers: the investigator answers the queries according to the queries and signs the answer form to confirm. The process is repeated until the queries are all resolved and the data are clean. 2. Medical coding: Adverse events were coded using MedDRA V22.0 or higher dictionary, and combined medications were classified using WHO ATC.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-02-05 19:56:20