NCT03650608已完成1 期
A Dose Block-randomized, Double-blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Single Dosing of HL217 Eye Drop in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Clinical parameter: Adverse Events (AE)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and PK parameters in healthy subjects.
详细描述
The purpose of this study is to evaluate the safety, tolerability and PK parameters of HL217 after single eye drop administration at different doses in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject, aged between 18 and 50 years inclusive
- •Non-smoker subject or smoker of not more than 10 cigarettes a day and able to stop smoking 24 hour prior to admission until discharge
- •Body weight ≥ 50 kg and BMI between 18 and 30 kg/m²
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination) including complete ocular examination
- •Normal Blood Pressure (BP) and Heart Rate (HR) after 10 minutes in supine position:
- •90 mmHg ≤ Systolic Blood Pressure (SBP) ≤ 140 mmHg
- •45 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg
- •40 bpm ≤ HR ≤ 100 bpm
- •Or considered NCS by investigators
- •Normal ECG recording on a 12-lead ECG:
- •120 < PR < 200 ms
- •QRS < 120 ms
- •QTcf ≤ 430 ms
- •No sign of any trouble of sinusal automatism
- •Or considered NCS by investigators
- •Laboratory parameters within the normal range of the laboratory (haematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator
- •Normal dietary habits
- •Signing a written informed consent prior to selection
排除标准
- •Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious or ocular disease
- •Frequent headaches and / or migraine, recurrent nausea and / or vomiting
- •Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position
- •Blood donation (including in the frame of a clinical trial) within 2 months before administration or apheresis within 20 days before administration
- •General anaesthesia within 3 months before administration
- •Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician (including allergy to fluorescein)
- •Inability to abstain from intensive muscular effort
- •No next of kin, easily accessible, in case of emergency
- •Any drug or herbal medicine intake (except paracetamol) during the last 14 days prior to the first administration, any over the counter medicine or vitamin during the last 7 days prior to the first administration
- •Subjects who have taken drug metabolizing enzyme inducing agents and inhibitors such as barbitals within a month prior to the first administration
- •History or presence of drug or alcohol abuse (alcohol consumption > >21 units per week)
- •Excessive consumption of beverages with xanthine bases (> 5 cups or glasses / day) and not able to stop 24h prior to admission until discharge
- •Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2
- •Major surgery (general or ocular) within 28 days prior to randomization or major surgery planned during the next 6 months
- •Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
- •Subjects within an exclusion period of a previous study or subjects who have taken any investigational product from other clinical trials within 60 days from the start of the study (from the administration of investigational product)
- •Subjects with previous participation in the current study
- •Subject under administrative or legal supervision
- •Subjects with an allergy to Fluorescein
- •History of any ocular surgery within the past 6 months prior to study participation
- •Subject who have intraocular pressure > 21 mmHg
- •Subject with acute or chronic eye problems that require eye drop at the time of screening
- •Best-corrected ETDRS visual acuity score ≤ 85 (Snellen equivalent 20/20)
- •Subject who need to wear contact lens during the study.
研究组 & 干预措施
Placebo Ophthalmic solution
Placebo Comparator
Placebo Ophthalmic solution, two drop once or twice or four times a day
干预措施: Placebo Ophthalmic solution (Drug)
结局指标
主要结局
Clinical parameter: Adverse Events (AE)
时间窗: During 72hours
AEs will be coded according to the MedDRA. They will be classified into pre-defined standard categories according to chronological criteria
Local tolerance: Redness, Tingling and Other ophthalmic adverse events
时间窗: During 72hours
Redness, tingling and others should be checked
次要结局
- Pharmacokinetic assessment: AUClast(0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour)
- Pharmacokinetic assessment: AUCinf(0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour)
- Pharmacokinetic assessment: Kel(0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour)
- Pharmacokinetic assessment: Cl/F(0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour)
- Pharmacokinetic assessment: Cmax(0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour)
- Pharmacokinetic assessment: Tmax(0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour)
- Pharmacokinetic assessment: T1/2(0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour)
- Pharmacokinetic assessment: %AUCextra(0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour)
- Pharmacokinetic assessment: Vd/F(0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour)
研究者
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