中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500101173
最近更新日期： Date of Last Refreshed on：	2025-04-21 16:50:07
注册时间： Date of Registration：	2025-04-21 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项评价KR230109在健康受试者中单次与多次经皮给药的单中心、随机、双盲、安慰剂对照、剂量递增设计的安全性、耐受性、药代动力学特征的Ⅰ期临床试验
Public title：	A single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial evaluating the safety, tolerability and pharmacokinetic characteristics of single and multiple transdermal administration of KR230109 in healthy subjects.
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项评价KR230109在健康受试者中单次与多次经皮给药的单中心、随机、双盲、安慰剂对照、剂量递增设计的安全性、耐受性、药代动力学特征的Ⅰ期临床试验
Scientific title：	A single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial evaluating the safety, tolerability and pharmacokinetic characteristics of single and multiple transdermal administration of KR230109 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：	徐满	研究负责人：	阳国平
Applicant：	Xu Man	Study leader：	Yang Guoping
申请注册联系人电话： Applicant telephone：	+86 199 7970 3650	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：	xuman@kryy.com.cn	研究负责人电子邮件： Study leader's E-mail：	ygp9880@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：	江西省赣州市章贡区青峰大道188 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. 188, Qingfeng Avenue, Zhanggong District, Ganzhou City, Jiangxi 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：	341000	研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	江西科睿药业有限公司
Applicant's institution：	Jiangxi Kerui Pharmaceutical Co., Ltd.
研究负责人所在单位：	中南大学湘雅三医院
Affiliation of the Leader：	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25274	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, Central South University
伦理委员会批准日期： Date of approved by ethic committee：	2025-04-14 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：	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 City, Hunan Province
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：

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：

No. 138, Tongzipo 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：	Hunan	City：	Changsha
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 of Central South University	Address：	No. 138, Tongzipo Road, Yuelu District, Changsha City, Hunan Province

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：

寻常型痤疮

Target disease：

Acne vulgaris

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KR230109在健康成年受试者中单次与多次局部皮肤给药后的安全性与耐受性，为确定后期试验所采用的给药剂量及面积提供安全性依据。次要研究目的评价KR230109在健康成年受试者中单次与多次局部皮肤给药的系统暴露水平和药代动力学（PK）特征。

Objectives of Study：

The primary objective of the study is to evaluate the safety and tolerability of KR230109 after single and multiple local skin applications in healthy adult subjects, providing a safety basis for determining the dosage and application area in subsequent trials. The secondary objective is to assess the systemic exposure levels and pharmacokinetic (PK) characteristics of KR230109 after single and multiple local skin applications in healthy adult 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：

Inclusion criteria

排除标准：

怀疑对本研究药物或研究药物中的任何成份过敏，或既往有过敏性疾病（如过敏性鼻炎、过敏性哮喘等）、药物过敏史、皮肤过敏史（包括但不限于对贴膏过敏，对金属、化妆品或家居用品有接触性皮炎）者，或已知为过敏体质，如对两种或以上药物和食物过敏史；既往或现患有以下疾病且研究者认为不可入组者，包括但不限于神经系统、心血管系统、血液和淋巴系统、免疫系统、肾脏、肝脏、胃肠道、呼吸系统、代谢及骨骼等系统疾病及恶性肿瘤等；研究者认为受试者患有研究禁忌或影响给药部位评估的临床相关的皮肤疾病，例如日光性皮炎、银屑病、脂溢性皮炎、酒渣鼻、毛囊炎、特异性皮炎、湿疹及极重度痤疮等；目标涂药区域存在纹身、胎记、皮肤瘢痕、破溃、晒伤、皮肤穿孔、皮肤菲薄、异常发热等研究者认为可能影响试验药物给药部位评估的皮肤损伤或异常；皮肤划痕试验阳性者；筛选前一年内有频繁的感染病史，或给药前3个月内有复发性口腔疱疹、生殖器疱疹、带状疱疹等复发性病毒感染史者；筛选前1个月内发生过经研究者判定有临床意义的感染者，包括急慢性感染如脓肿、疖、痈等局部感染、呼吸道感染、泌尿生殖道感染、全身感染等；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；筛选前3个月内接受过任何外科手术，或研究期间计划手术者；经研究者判定生命体征、体格检查、临床实验室检查值（血常规、尿常规、血生化、凝血功能）、12导联心电图（QTcF间期>450ms，QTcF采用Fridericia公式计算，为QTcF=QT/(RR^0.33)）、腹部B超、胸部正位X片检查结果异常且有临床意义者；试验给药前14天内使用过任何药物或保健品（包括中草药）者，以及在目标涂药区域使用皮肤外用药品、皮肤晒黑用品者；研究药物给药前2天内在目标涂药区域使用皮肤外用产品（包括润肤剂）者；研究药物给药前3个月内接受过生物制剂（抗体或其衍生物）者；筛选前1个月内使用过任何CYP3A4抑制剂/诱导剂（强效抑制剂如伊曲康唑、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，中效抑制剂如红霉素、维拉帕米等，弱效抑制剂如伏佛沙明等；强诱导剂如卡马西平、苯妥英、苯巴比妥、圣约翰草等；中效诱导剂如依非韦伦等）者。如果既往使用药物的半衰期较长，则所需的时间间隔将更长，应至少为该药物的5个半衰期；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（如可乐、红牛等，>8杯/天，1杯=250 mL）者；

Exclusion criteria：

Those who are suspected of allergic to this study drug or any of the ingredients in the study drug, or have a history of allergic diseases (such as allergic rhinitis, allergic asthma, etc.), drug allergies, skin allergies (including but not limited to allergy to plasters, contact dermatitis to metals, cosmetics or household products), or known allergies, such as a history of allergies to two or more drugs and food; Those who have the following diseases in the past or present and are considered by the investigator to be ineligible for enrollment, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic and bone and other system diseases and malignant tumors; In the opinion of the investigator, the subject has clinically relevant skin diseases that are contraindicated in the study or affect the evaluation of the dosing site, such as solar dermatitis, psoriasis, seborrheic dermatitis, rosacea, folliculitis, atopic dermatitis, eczema and extremely severe acne, etc.; Tattoos, birthmarks, skin scars, ulcers, sunburns, skin perforations, thin skin, abnormal fever, and other skin lesions or abnormalities that the investigator believes may affect the evaluation of the test drug administration site in the target application area; Those with positive skin scratch test; Those who have a history of frequent infections within one year before screening, or a history of recurrent oral herpes, genital herpes, shingles and other recurrent viral infections within 3 months before administration; Those who have had clinically significant infections within 1 month prior to screening, including acute and chronic infections such as abscesses, boils, carbuncles and other local infections, respiratory tract infections, genitourinary tract infections, systemic infections, etc.; Those who have received live (attenuated) vaccines within 2 months before screening, or plan to receive live vaccines during the study period; Those who have undergone any surgical operation within 3 months prior to screening, or who plan surgery during the study; Those who were judged by the investigator to have abnormal vital signs, physical examination, clinical laboratory test values (blood routine, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram (QTcF interval >450ms, QTcF calculated by Fridericia formula, QTcF=QT/(RR^0.33)), abdominal B-ultrasound, and anteroposterior chest X-ray examination results were abnormal and clinically significant; Those who have used any drugs or health products (including Chinese herbal medicines) within 14 days before the trial administration, as well as those who have used topical skin drugs and skin tanning products in the target application area; Those who use topical skin products (including emollients) in the target application area within 2 days before the administration of the study drug; Those who have received biological agents (antibodies or their derivatives) within 3 months before the administration of the study drug; Use of any CYP3A4 inhibitors/inducers within 1 month before screening (strong inhibitors such as itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone, etc., moderate inhibitors such as erythromycin, verapamil, etc., weak inhibitors such as vorfoxamine, etc.; strong inducers such as carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.; Medium-acting inducers, such as efavirenz, etc.). If the half-life of the drug has been long in the past, the required time interval will be longer, which should be at least 5 half-lives of the drug; Excessive tea consumption per day within 3 months prior to screening (> 15g tea leaves/day; Generally, 3~5g of tea leaves are brewed each time), coffee and/or caffeine-rich beverages (such as Coke, Red Bull, etc., >8 cups/day, 1 cup = 250 mL);

研究实施时间：

Study execute time：

从 From 2025-04-14 00:00:00至 To 2025-09-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-04-27 00:00:00 至 To 2025-07-30 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	40
Group：	Experimental group	Sample size：	40
干预措施：	KR230109 组	干预措施代码：
Intervention：	KR230109 Group	Intervention code：

组别：	安慰剂组	样本量：	8
Group：	placebo group	Sample size：	8
干预措施：	安慰剂	干预措施代码：
Intervention：	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)：	长沙市
Country：	China	Province：	Hunan	City：	Changsha
单位(医院)：	中南大学湘雅三医院	单位级别：	三甲
Institution hospital：	Third Xiangya Hospital of Central South University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

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：	药代动力学	指标类型：	次要指标
Outcome：	Pharamcokinetics,PK	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：

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）：

本研究采用随机双盲设计，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。

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

This study adopted a randomized double-blind design. An independent non-blinded statistician generated the randomization tables for each dose group using SAS version 9.4 or higher.

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：	双盲设计，即研究者与受试者均设盲
Blinding：	Double-blind design, that is, both the researchers and the subjects are blinded.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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：	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：	暂未确定/Not yet
注册人： Name of Registration：	2025-04-21 16:50:02