A Randomized, Open-label Phase I Clinical Study to Evaluate the Systemic Pharmacokinetics and Safety of Atropine Sulfate Eye Drops in Healthy Chinese Volunteers

Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2023年5月9日最近更新: 2023年5月11日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited
入组人数: 30
试验地点: 1
主要终点: Time of half-life (t1/2)

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

To evaluate the systemic pharmacokinetics and the safety of atropine sulfate eye drops in healthy volunteers.

详细描述

This is a randomized, open-label, phase I clinical study evaluating the systemic pharmacokinetics and safety of atropine sulfate eye drops in healthy Chinese volunteers.Three concentrations will be investigated, each concentration group must contain both male and female subjects, and each subject receives only one concentration of atropine sulfate eye drop in this study.

The three treatment arms are:

Atropine sulfate dose A (low concentration)

Atropine sulfate dose B (medium concentration)

Atropine sulfate dose C (high concentration)

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
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 subject is a male or female Chinese with his/her biological parents and grandparents are of Chinese ethnicity, aged 18-45 (including cut-off value) at screening;
•Subject with a body mass index (BMI) between 19.0-26.0kg/m2 (including cut-off value), male weight ≥50.0kg, female weight ≥45.0kg at screening and D0;
•Subject is in good health, as determined by the investigator, based on medical history, no findings of clinical significant abnormalities at physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening and D0;

排除标准

•Subject with any eye with corrected visual acuity <1.0, clinically significant abnormal intraocular pressure, slit lamp and fundus examination.
•Subject with history of eye diseases, including the history of internal eye surgery or laser surgery.
•Subject with clinically significant history of the central nervous system, mental, cardiovascular, kidney, liver, respiratory, metabolic, and musculoskeletal system diseases etc., which may endanger the safety of the subject or affect the results of the study, as judged by the investigator.
•Subject with clinically significant history of allergies, such as drug allergies, especially those who are allergic to any component of atropine sulfate eye drops.
•On average, subject smokes more than 5 cigarettes per day or that who ex-smokes less than 3 months.
•Subject has used any topical or systemic antimuscarinic/anticholinergic drugs (e.g., atropine, 1-hyoscyamine, tropicamide, chlorpheniramine, diphenhydramine, oxytropine, cyclic antidepressants, etc.) within 3 weeks before screening.
•Subject has used any local or systemic drugs (including any prescription or over-the-counter drugs) within 2 weeks before screening.
•Subject has participated in interventional clinical trials within 3 months before screening.
•Subject who has worn contact lenses or cosmetic contact lenses within 1 weeks before screening.
•Subject who is pregnant or breastfeeding.
•The investigator believes that the subject is not suitable to participate in the trial.

研究组 & 干预措施

Atropine sulfate Concentration A

Experimental

Subjects will be treated with atropine sulfate eye drop (at dosage Concentration A), administered once daily (QD).

干预措施: Atropine sulfate eye drops (Drug)

Atropine sulfate Concentration B

Experimental

Subjects will be treated with atropine sulfate eye drop (at dosage Concentration B), administered once daily (QD).

干预措施: Atropine sulfate eye drops (Drug)

Atropine sulfate Concentration C

Experimental

Subjects will be treated with atropine sulfate eye drop (at dosage Concentration C), administered once daily (QD).

干预措施: Atropine sulfate eye drops (Drug)