To Evaluate the Local Pharmacokinetic Characteristics of Single Administration of Germinal Peptide Eye Drops in Healthy Volunteers in a Phase I Clinical Study

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.1 个研究点分布在 1 个国家目标入组 106 人开始时间: 2021年4月9日最近更新: 2021年9月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 106
试验地点: 1
主要终点: Area under curve （0-t）

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The subjects of this study were healthy subjects, who were given medicine in a single dose group: 0.004%.

详细描述

Tear collection was conducted on the single dose D1 (that is, the day of administration). Collection points: 10 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, and 12 h after administration.Each time 5-50 mg (generally 20 mg), a total of 160-1600 mg of tears will be collected (during the screening period, all subjects will retain the tear samples collected by the Schirmer filter paper, among which, qualified tear samples will be used for blank samples or methodological investigation.After administration, only 1 tear collection site will be collected for each subject.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•healthy volunteers aged between 18 and 45, both male and female in each group;
•body mass index between 19 and 26 kg/m2 (including critical value), male weight 50 kg, female weight 45 kg;
•target eye Schirmer Ⅰ test (Schirmer filter paper bending, clip next eyelid medial 1/3 conjunctival sac within 5 min) tear wet filter paper length or greater 10 mm;
•subjects will participate in the study voluntarily and sign the informed consent.

排除标准

•binocular corrected vision < 1.0, abnormal intraocular pressure, slit lamp and fundus examination with clinical significance;
•those with abnormal physical examination, vital signs, electrocardiogram and laboratory examination before the test with clinical significance;
•patients with eye diseases, including history of inner eye surgery or laser surgery;
•a medical history of central nervous system, spirit, cardiovascular system, kidney, liver, respiratory system, metabolism system and skeletal muscle system, which may endanger the safety of subjects or affect the results of the study;
•positive test results of hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (hcv-ab), treponema pallidum specific antibody (tp-ab) or human immunodeficiency virus antibody (hiv-p24 /Ab);
•have a significant history of clinical allergy, especially drug allergy, especially allergic to any component of germinal peptide eye drops;
•smoking more than 5 cigarettes per day on average;
•those who are suspected or have alcohol dependence, and their alcohol intake is more than 2 units per day on average for 3 months (1 unit =10 mL ethanol, that is, 1 unit =200 mL beer with 5% alcohol or 25 mL spirit with 40% alcohol or 83 mL wine with 12% alcohol) or who have tested positive for alcohol;
•history of drug abuse, or positive urine test of ketamine, morphine, methamphetamine, dimethylene dioxyamphetamine, tetrahydrocannabinic acid;
•have taken any medicine within 2 weeks before screening;
•participated in clinical trials within the first 3 months of screening;
•blood donation or blood loss 400 mL within 3 months before screening;
•have used ophthalmic drugs or eyelash growth solution in the first 2 weeks;
•select the subjects who have worn contact lenses or contact lenses in the first 2 weeks;
•pregnant or lactating women and those planning to become pregnant (including male subjects);No effective contraceptive measures were taken within 1 month prior to the inclusion of subjects, or subjects (including male subjects) were unwilling to take effective contraceptive measures within the next 6 months;
•the researchers considered the participants unsuitable.

研究组 & 干预措施

0.004% single-dose

Experimental

96 subjects will be treated with Germinal peptide eye drops 0.004% single dose (16 were pre-tested and 64 were formally tested).

干预措施: Germinal peptide eye drops (Drug)