NCT06813807
已完成
1 期
A Comparative Study of the Pharmacokinetic Profiles of Timolol Maleate Ophthalmic Gel Forming Solution After Multiple Dosing in Healthy Subjects with That of Timolol Maleate Gel in Subjects with Proliferating Superficial Infantile Hemangioma Who Have Completed the Study
Auson Pharmaceuticals Inc.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年6月15日最近更新:
概览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Auson Pharmaceuticals Inc.
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cmax,ss
概览
简要总结
The goal of this clinical trial is:
1)To evaluate the pharmacokinetic profiles and safety of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects after multiple dosing; 2)To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% Timolol Maleate Gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects.
The main questions aim to answer are:
- Pharmacokinetic (PK) profiles of healthy adult subjects
- Safety Evaluation
- To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% timolol maleate gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% timolol maleate ophthalmic gel forming solution in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age and gender: Healthy male or female subjects aged 18 to 50 years old (inclusive);
- •Weight: ≥ 50 kg for male, ≥ 45 kg for female; body mass index (BMI) between 19 and 26 kg/m2 (inclusive), where BMI = weight (kg) / height2 (m2);
- •Ophthalmic examinations during screening include visual acuity, color vision, intraocular pressure, slit-lamp examination (of eyelids, lacrimal apparatus, anterior chamber, conjunctiva, etc.) and fundus examination must be normal or abnormal without clinical significance;
- •Refractive myopia \< 600 degrees, corrected visual acuity ≥ 0.8 in both eyes;
- •Subjects with no abnormal or with abnormal but not clinically significant results in vital signs measurement, physical examination, clinical laboratory tests (hematology, urinalysis, blood biochemistry, infectious disease test and coagulation function), pregnancy test (women of childbearing age), and 12-lead ECG;
- •Male subjects and their partners or female subjects must agree to take one or more non-drug contraceptive measures (such as complete abstinence, intrauterine ring and partner ligation) during the study and for 3 months after the end of the study, and have no plan of sperm or egg donation; Subjects have a full understanding of the study content, investigational drugs, study process, etc., and are able to communicate well with the investigator, willing to comply with the study regulations, and voluntarily sign the informed consent form.
排除标准
- •(Screening period inquiry + check-in inquiry) Subjects with a history of respiratory system (especially bronchial asthma, bronchospasm, chronic obstructive pulmonary disease), cardiovascular system, digestive system, endocrine system, urinary system, nervous system, hematological, immunological, psychiatric disorders or a family history of genetic psychosis, cancer, etc., and are considered by the investigator to still have clinical significance;
- •(Screening period inquiry) Subjects with a history of diabetes, thyrotoxicosis, cardiogenic shock, second- to third-degree atrioventricular block, heart failure, significant sinus bradycardia, hypotension, sick sinus syndrome, severe peripheral vascular disease with resting ischemia and whose condition is assessed by the study physician to be abnormal but clinically significant;
- •(Screening period inquiry + check-in inquiry) Subjects who have undergone surgery within 6 months before the first dose that will affect drug absorption, distribution, metabolism and excretion as judged by the investigator; or who have undergone surgery within 4 weeks before the first dose; or who plan to undergo surgery during the study period;
- •(Screening period inquiry) Subjects with a history of or currently suffering from any acute and chronic eye diseases, or with ocular mixed infections, inflammation, trauma or other ophthalmic conditions with clinical significance(e.g., keratoconus, severe dry eye) within 1 month before the first dose, active eye diseases, or acute or chronic allergic eye diseases or any abnormalities in the eyelids, ocular surface, and lacrimal passage system that may affect the absorption of eye drops in the opinion of the investigator;
- •(Screening period inquiry) Subjects with a history of ocular trauma or eye surgery;
- •Subjects whose elevated intraocular pressure exceeds the normal range (10 \~ 21 mmHg), with the pressure difference of greater than 5 mmHg between both eyes and considered clinically significant by the study doctor;
- •Subjects with keratopathy, corneal thickness greater than 600 um (normal central corneal thickness is 500 \~ 600 um) or corneal scarring, wearing contact lenses (including night wear orthokeratology lenses) or having to wear contact lenses during the study, which affect the intraocular pressure measurement and are considered clinically significant by the study physician;
- •(Screening period inquiry) Those with evidence or a history of acute and chronic angle-closure glaucoma;
- •(Screening period inquiry + check-in inquiry) Those who have used any drugs that inhibit or induce hepatic drug metabolizing enzymes or interact with the study drugs (adrenoceptor inhibitors, digitalis and calcium antagonists, catecholamine-depleting drugs, clonidine, quinidine, etc.) within 30 days prior to the first dose;
- •(Screening period inquiry + check-in inquiry) Subjects who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, vaccines or health products for various reasons within 14 days prior to the first dose in the study;
研究组 & 干预措施
0.5%TM
Experimental
18 subjects will receive one drop of 0.5% timolol maleate ophthalmic gel forming solution each in the left and right eyes once daily.
干预措施: 0.5% TM (Drug)
结局指标
主要结局
Cmax,ss
时间窗: 24 hours after administration
maximum plasma concentration at steady state
AUC0-t,ss
时间窗: 24 hours after administration
area under the plasma concentration-time curve from the last dose to the collection time t of the last measurable concentration
AUC0-24,ss
时间窗: 24 hours after administration
area under the plasma concentration-time curve over a 24-h dosing interval at steady state
AUC0-∞,ss
时间窗: 24 hours after administration
area under the plasma concentration-time curve extrapolated from the last dose to infinity at steady state
次要结局
未报告次要终点
研究者
研究点 (1)
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