ChiCTR2100052462 版本V1.1 版本创建时间2022/04/28 17:38:32 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：

 ChiCTR2100052462 

最近更新日期：

Date of Last Refreshed on：

 2021-10-27 22:47:24 

注册时间：

Date of Registration：

 2021-10-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

该研究尚未获得伦理委员会批准，请于批准后再开始纳入参试者，并与我们联系上传批件。 一项洛索洛芬钠滴眼液单次/多次给药在健康受试者中的安全性、耐受性和药代动力学特征的I期临床试验

Public title：

A phase I clinical trial on the safety, tolerability and pharmacokinetics of loxoprofen sodium eye drops in healthy subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项洛索洛芬钠滴眼液单次/多次给药在健康受试者中的安全性、耐受性和药代动力学特征的I期临床试验

Scientific title：

A phase I clinical trial on the safety, tolerability and pharmacokinetics of loxoprofen sodium eye drops 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：

梁翅勇 

研究负责人：

丁雪鹰 

Applicant：

Chiyong Liang 

Study leader：

Xueying Ding 

申请注册联系人电话：

Applicant telephone：

 13761642319

研究负责人电话：

Study leader's
telephone：

13761642319

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：

 re_lcy@gdgrg.cn

研究负责人电子邮件：

Study leader's E-mail：

 dingxueying@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：

黄埔区国际生物岛螺旋三路29号7楼

研究负责人通讯地址：

上海市虹口区武进路85号

Applicant address：

Floor 7, No. 29, helix 3 Road, International Biological Island, Huangpu District, Guangzhou

Study leader's address：

No. 85, Wujin Road, Hongkou District, Shanghai

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：

广州润尔眼科生物科技有限公司

Applicant's institution：

Guangzhou Ocusun ophthalmology Biotechnology Co., Ltd

研究负责人所在单位：

上海市第一人民医院

Affiliation of the Leader：

Shanghai General Hospital

是否获伦理委员会批准：

否

Approved by ethic committee：

No

伦理委员会批件文号：

Approved No. of ethic committee：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

上海市第一人民医院

Primary sponsor：

Shanghai General Hospital

研究实施负责（组长）单位地址：

虹口区武进路85号

Primary sponsor's address：

No. 85, Wujin Road, Hongkou District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市第一人民医院

具体地址：

虹口区武进路85号

Institution
hospital：

Shanghai General Hospital

Address：

85 Wujin Road, Hongkou District

经费或物资来源：

申办方自筹

Source(s) of funding：

Self raised by the sponsor

研究疾病：

过敏性结膜炎/术后抗炎  

Target disease：

Allergic conjunctivitis / postoperative anti-inflammatory

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： 评价洛索洛芬钠滴眼液单次/多次给药在健康受试者中的安全性和耐受性，为后期临床研究提供剂量设置依据。 次要目的： 评价洛索洛芬钠滴眼液单次/多次给药在健康受试者中的药代动力学特征。  

Objectives of Study：

Main purpose: To evaluate the safety and tolerance of single / multiple administration of loxoprofen sodium eye drops in healthy subjects, so as to provide basis for dose setting for later clinical studies. Secondary purpose: To evaluate the pharmacokinetics of loxoprofen sodium eye drops 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.年龄在18~45周岁的健康受试者（包括18和45周岁）；
2.体重：男性受试者不应低于50.0 kg，女性受试者不应低于45.0 kg，体重指数[BMI=体重(kg)/身高2(m2)]在19.0～26.0 kg/m2范围内（包括临界值）；
3.双眼矫正视力均应≥1.0，眼科检查（包括眼压、彩色眼底照相、标准眼科检查及角膜荧光染色等）均正常或异常无临床意义；
4.自愿参加研究，并签署知情同意书。

Inclusion criteria

1. Healthy subjects aged 18-45 years (including 18 and 45 years);
2. Weight: male subjects should not be less than 50.0 kg, female subjects should not be less than 45.0 kg, and body mass index [BMI = weight (kg) / height 2 (M2)] is in the range of 19.0 ~ 26.0 kg / m2 (including critical value);
3. The corrected visual acuity of both eyes shall be ≥ 1.0, and the ophthalmic examination (including intraocular pressure, color fundus photography, standard ophthalmic examination and corneal fluorescence staining) is normal or abnormal, without clinical significance;
4. Voluntarily participate in the study and sign the informed consent form.

排除标准：

1.现患眼部疾病者；
2.既往有内眼手术史或激光手术史者；
3.筛选前2周内佩戴过角膜接触镜或美瞳的受试者，或试验期间需佩戴角膜接触镜者；
4.筛选前2周内使用过任何药物，包括眼用药物者；
5.现患有中枢神经、精神、心血管、肾脏、肝脏、呼吸、代谢及骨骼肌肉等系统疾病者；
6.体格检查、生命体征、心电图、实验室检查研究者判定异常有临床意义者；
7.现患有胃肠道疾病包括胃肠道出血、溃疡、穿孔等疾病者；
8.传染病筛查[乙型肝炎病毒表面抗原（HBsAg）、丙型肝炎病毒（HCV）抗体、梅毒螺旋体抗体和人类免疫缺陷病毒（HIV）抗体]检查结果呈阳性者；
9.临床上有显著的变态反应史，特别是药物过敏史，或已知对本药组分或活性代谢产物过敏者；
10.筛选前3个月平均每日吸烟量大于5支者或者在给药前48 h直至出组不能放弃吸烟者；
11.筛选前3个月酒精摄入量平均每天超过2个单位（1单位=10 mL乙醇，即1单位=200 mL酒精量为5%的啤酒或25 mL酒精量为40%的烈酒或85 mL酒精量为12%的葡萄酒），或给药前48 h直至出组不能放弃饮酒者，或酒精呼气测试阳性者；
12.筛选前1年有药物滥用史，或药物滥用筛查[氯胺酮、吗啡、甲基安非他明、二亚甲基双氧安非他明、四氢大麻酚酸、可卡因]呈阳性者；
13.筛选前3个月内参加过临床试验者；
14.筛选前3个月内献血或失血≥400 mL者（女性生理期失血除外）；
15.有晕针晕血史或静脉采血困难者；
16.对饮食有特殊要求者，不能遵守提供的饮食和相应的规定，给药前48 h直至出组不能避免食用含黄嘌呤/咖啡因的饮料（咖啡、茶、可乐等）或食物（动物肝脏、巧克力等），或食用可能影响代谢的水果或果汁（葡萄柚、柚子、芒果等）者；
17.育龄期女性妊娠试验阳性，或受试者（包括男性受试者）试验期间至出组后3个月内有生育计划且不愿采取有效避孕措施；
18.不符合国家或上海市或上海市第一人民医院针对新冠病毒疫情防控要求者；
19.研究者认为不适合参加本试验者。

Exclusion criteria：

1. Patients with eye diseases;
2. Previous history of internal eye surgery or laser surgery;
3. Subjects who have worn corneal contact lenses or pupil beautification within 2 weeks before screening, or who need to wear corneal contact lenses during the test;
4. Those who have used any drugs, including ophthalmic drugs, within 2 weeks before screening;
5. Currently suffering from central nervous, mental, cardiovascular, kidney, liver, respiratory, metabolic and skeletal muscle diseases;
6. Physical examination, vital signs, electrocardiogram and laboratory examination. The researcher determines that the abnormality is of clinical significance;
7. Currently suffering from gastrointestinal diseases, including gastrointestinal bleeding, ulcer, perforation and other diseases;
8. The results of infectious disease screening [hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody and human immunodeficiency virus (HIV) antibody] are positive;
9. Patients with clinically significant allergic reaction history, especially drug allergy history, or known allergy to components or active metabolites of the drug;
10. Those who smoke more than 5 cigarettes per day in the three months before screening or who cannot give up smokers 48 hours before administration until they are out of the group;
11. The average alcohol intake in the three months before screening exceeds 2 units per day (1 unit = 10 ml of ethanol, i.e. 1 unit = 200 ml of beer with 5% alcohol or 25 ml of spirits with 40% alcohol or 85 ml of wine with 12% alcohol), or those who cannot give up drinking 48 hours before administration until they are out of the group, or those with positive alcohol breath test;
12. Those who have a history of drug abuse one year before screening or who are positive for drug abuse screening [ketamine, morphine, methamphetamine, dimethylbisoxyamphetamine, tetrahydrocannabinoic acid and cocaine];
13. Those who have participated in clinical trials within 3 months before screening;
14. Those who donate blood or lose blood ≥ 400 ml within 3 months before screening (except female blood loss in physiological period);
15. Have a history of needle fainting and blood fainting or difficulty in venous blood collection;
16. Those who have special requirements for diet cannot abide by the provided diet and corresponding regulations. They cannot avoid eating beverages (coffee, tea, cola, etc.) or foods (animal liver, chocolate, etc.) containing xanthine / caffeine 48 hours before administration until they are out of the group, or eating fruits or fruit juices (grapefruit, grapefruit, mango, etc.) that may affect metabolism;
17. Women of childbearing age have positive pregnancy test, or subjects (including male subjects) have family planning from the test period to 3 months after leaving the group and are unwilling to take effective contraceptive measures;
18. does not meet the national or Shanghai or Shanghai First People's Hospital for COVID-19 epidemic prevention and control requirements;
19. The researcher believes that it is not suitable to participate in this experiment.
1. Patients with eye diseases;

2. Previous history of internal eye surgery or laser surgery;

3. Subjects who have worn corneal contact lenses or pupil beautification within 2 weeks before screening, or who need to wear corneal contact lenses during the test;

4. Those who have used any drugs, including ophthalmic drugs, within 2 weeks before screening;

5. Currently suffering from central nervous, mental, cardiovascular, kidney, liver, respiratory, metabolic and skeletal muscle diseases;

6. Physical examination, vital signs, electrocardiogram and laboratory examination. The researcher determines that the abnormality is of clinical significance;

7. Currently suffering from gastrointestinal diseases, including gastrointestinal bleeding, ulcer, perforation and other diseases;

8. The results of infectious disease screening [hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody and human immunodeficiency virus (HIV) antibody] are positive;

9. Patients with clinically significant allergic reaction history, especially drug allergy history, or known allergy to components or active metabolites of the drug;

10. Those who smoke more than 5 cigarettes per day in the three months before screening or who cannot give up smokers 48 hours before administration until they are out of the group;

11. The average alcohol intake in the three months before screening exceeds 2 units per day (1 unit = 10 ml of ethanol, i.e. 1 unit = 200 ml of beer with 5% alcohol or 25 ml of spirits with 40% alcohol or 85 ml of wine with 12% alcohol), or those who cannot give up drinking 48 hours before administration until they are out of the group, or those with positive alcohol breath test;

12. Those who have a history of drug abuse one year before screening or who are positive for drug abuse screening [ketamine, morphine, methamphetamine, dimethylbisoxyamphetamine, tetrahydrocannabinoic acid and cocaine];

13. Those who have participated in clinical trials within 3 months before screening;

14. Those who donate blood or lose blood ≥ 400 ml within 3 months before screening (except female blood loss in physiological period);

15. Have a history of needle fainting and blood fainting or difficulty in venous blood collection;

16. Those who have special requirements for diet cannot abide by the provided diet and corresponding regulations. They cannot avoid eating beverages (coffee, tea, cola, etc.) or foods (animal liver, chocolate, etc.) containing xanthine / caffeine 48 hours before administration until they are out of the group, or eating fruits or fruit juices (grapefruit, grapefruit, mango, etc.) that may affect metabolism;

17. Women of childbearing age have positive pregnancy test, or subjects (including male subjects) have family planning from the test period to 3 months after leaving the group and are unwilling to take effective contraceptive measures;

18. does not meet the national or Shanghai or Shanghai First People's Hospital for COVID-19 epidemic prevention and control requirements;

19. The researcher believes that it is not suitable to participate in this experiment.

研究实施时间：

Study execute time：

从 From 2021-10-19 00:00:00至 To 2022-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-10-25 00:00:00 至 To 2021-12-17 00:00:00

干预措施：

Interventions：

组别：

1组

样本量：

 2

Group：

Group 1

Sample size：

干预措施：

0.05%试验药物或安慰剂，1滴，1次

干预措施代码：

Intervention：

0.05% test drug or placebo, 1 drop, 1 time

Intervention code：

组别：

2组

样本量：

 10

Group：

Group 2

Sample size：

干预措施：

0.1%试验药物或安慰剂，1滴，1次

干预措施代码：

Intervention：

0.1%Study drug or placebo, 1 drops, 1 time

Intervention code：

组别：

3组

样本量：

 10

Group：

Group 3

Sample size：

干预措施：

0.2%试验药物或安慰剂，1滴，1次

干预措施代码：

Intervention：

0.2%Study drug or placebo, 1 drops, 1 time

Intervention code：

组别：

4组

样本量：

 10

Group：

Group 4

Sample size：

干预措施：

0.3%试验药物或安慰剂，1滴，1次

干预措施代码：

Intervention：

0.3%Study drug or placebo, 1 drops, 1 time

Intervention code：

组别：

5组

样本量：

 10

Group：

Group 5

Sample size：

干预措施：

0.4%试验药物或安慰剂，1滴，1次

干预措施代码：

Intervention：

0.4%Study drug or placebo, 1 drops, 1 time

Intervention code：

组别：

6组

样本量：

 10

Group：

Group 6

Sample size：

干预措施：

0.2%试验药物或安慰剂，1滴/次，4次/天，连续7天

干预措施代码：

Intervention：

0.2%Study drug or placebo, 1 drops / time, 4 times / day for 7 consecutive days

Intervention code：

组别：

7组

样本量：

 10

Group：

Group 7

Sample size：

干预措施：

0.3%试验药物或安慰剂，1滴/次，4次/天，连续7天

干预措施代码：

Intervention：

0.3%Study drug or placebo, 1 drops / time, 4 times / day for 7 consecutive days

Intervention code：

组别：

8组

样本量：

 10

Group：

Group 8

Sample size：

干预措施：

0.4%试验药物或安慰剂，1滴/次，4次/天，连续7天

干预措施代码：

Intervention：

0.4%Study drug or placebo, 1 drops / time, 4 times / day for 7 consecutive days

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海市第一人民医院 

单位级别：

 三级甲等 

Institution
hospital：

Shanghai General Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

安全性

指标类型：

主要指标

Outcome：

safety

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：

PK

Type：

Secondary 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：

主要指标

Outcome：

Pharmacokinetics

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）：

本试验采用区组随机化方法（单次给药0.025 mg剂量组除外），每个剂量组分别随机，组间比例为4:1，以SAS软件（9.4或以上版本）产生随机号以及随机号所对应治疗组别。

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

In this study, the block randomization method was adopted (except for the single dose group of 0.025 mg). Each dose group was randomized respectively, and the ratio between groups was 4:1. The random number and the treatment group corresponding to the random number were generated by SAS software (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：

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）：

不准备共享原始数据

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

No scheduled individual participant data (IPD) sharing

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：

CRF和EDC系统

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

Case Record Form and Electronic Data Capture System

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-10-27 22:47:20