A Randomized, Double-Blind, Vehicle-Controlled, Single-Center Phase Ia Study to Evaluate Systemic Pharmacokinetics, Safety, Tolerability in Healthy Subjects of PAN-90806 Eye Drops
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Corneal endothelial cell examination (density(cells/mm2)
研究概览
简要总结
The goal of this clinical trial is to learn about the safety, tolerability, and systemic pharmacokinetics of PAN-90806 eye drops in healthy adults. It will also evaluate what medical problems participants may have when taking PAN-90806. The main questions it aims to answer are:
Is PAN-90806 eye drops safe and well tolerated in healthy participants? What are the systemic pharmacokinetic characteristics of PAN-90806 after ocular administration? What medical problems or adverse events do participants have when taking PAN-90806? Researchers will compare PAN-90806 eye drops to a placebo (a look-alike eye drop that contains no PAN-90806) to evaluate the safety, tolerability, and systemic pharmacokinetics of PAN-90806.
Participants will:
Receive PAN-90806 eye drops or placebo eye drops once daily in both eyes, one drop per eye, on Day 1 and Days 3 to 7, for a total of 6 dosing days Stay at the study center during the inpatient dosing period and attend scheduled study visits for screening, admission, dosing, and discharge Undergo blood sampling for pharmacokinetic testing, as well as eye examinations, laboratory tests, vital signs assessments, physical examinations, and ECGs
详细描述
The goal of this Phase Ia clinical trial is to evaluate the safety, tolerability, and systemic pharmacokinetics of PAN-90806 eye drops in healthy adult volunteers. The study is designed to determine whether PAN-90806 eye drops can be administered safely in healthy participants and to describe how the drug is absorbed into the bloodstream after repeated ocular dosing. It will also assess what adverse events or other medical problems may occur during treatment.
The main questions this study aims to answer are:
Is PAN-90806 eye drops safe and well tolerated in healthy adult participants? What systemic pharmacokinetic characteristics does PAN-90806 show after administration as an eye drop? What eye-related or systemic adverse events occur during treatment with PAN-90806? Researchers will compare PAN-90806 eye drops with a placebo eye drop formulation that does not contain PAN-90806 but is otherwise identical in composition. This comparison will help evaluate the safety, tolerability, and systemic exposure profile of PAN-90806 under controlled conditions.
This is a randomized, double-blind, placebo-controlled, single-center Phase Ia study. A total of 20 healthy volunteers are planned for enrollment, with participants randomized in a 3:1 ratio to receive either PAN-90806 eye drops (10 mg/mL, 1.0%) or placebo eye drops. Both male and female participants may be enrolled. The study includes 4 visits: a screening visit from Day -14 to Day -1, an admission visit on Day 0, an inpatient dosing period from Day 1 to Day 8, and a discharge visit on Day 9. The total study duration for each participant is approximately 11 to 24 days.
Participants will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
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
- •**Inclusion Criteria:**
- •Aged 18 to 50 years, inclusive; male or female.
- •Body weight: males ≥50.0 kg, females ≥45.0 kg; body mass index (BMI) between 19.0 and 25.0 kg/m², inclusive.
- •At screening, in the investigator's judgment, the volunteer is in good health, with normal results or abnormal results without clinical significance for laboratory tests (hematology, blood chemistry, urinalysis), physical examination, vital signs, and ECG.
- •At screening, best-corrected visual acuity in either eye must be ≥0.8 (decimal notation using the national standard logarithmic visual acuity chart).
- •At screening, in the investigator's judgment, findings in either eye for intraocular pressure, slit-lamp examination, corneal endothelial cell examination, central corneal thickness examination, and non-mydriatic fundus photography are normal or abnormal without clinical significance; and both NEI corneal and conjunctival scores are ≤
- •Healthy volunteers (including women of childbearing potential and male healthy volunteers) must have no pregnancy plan during the trial and within 28 days after the end of the trial, and must voluntarily use effective contraception.
- •Healthy volunteers fully understand the study content, voluntarily participate and sign the informed consent form, and are willing to cooperate with completion of all study procedures.
排除标准
- •Women of childbearing potential who are pregnant or lactating; or a positive blood pregnancy test at screening (for women of childbearing potential only).
- •Active ocular inflammation or infection in either eye at screening.
- •History of intraocular surgery in either eye, or history of ocular laser surgery.
- •Wearing or planning to wear corneal or scleral contact lenses within 14 days before screening or during the study period.
- •At screening, in the investigator's judgment, any clinically significant disease or relevant medical history involving the eyes, immune system, cardiovascular system, kidneys, liver, respiratory system, metabolism, gastrointestinal system, endocrine system, blood, skin, sexually transmitted diseases, musculoskeletal system, nervous system, or psychiatric system that may affect the safety, tolerability, or systemic pharmacokinetic results of this trial.
- •Any symptoms of respiratory tract infection within 14 days before screening (such as fever, sore throat, headache, runny nose, etc.).
- •Use of any systemic (injectable or oral) or local (skin, eye, ear, or nose) medication within 28 days before screening or planned use during the study period, including over-the-counter cold or flu medications; however, local medications judged by the investigator not to affect the safety, tolerability, or systemic pharmacokinetic results of the trial are allowed as exceptions (such as artificial tears used outside the study period).
- •Participation in another drug or medical device clinical trial within 90 days before screening or planned participation during the study period.
- •Vaccination within 30 days before screening or planned vaccination during the study period.
- •Blood donation or blood loss exceeding 200 mL within 90 days before screening.
- •Any history of drug allergy, or known allergy at screening to any component of the investigational product or auxiliary medications required for study procedures.
- •Positive result for any of the four virology screening tests at screening (hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, human immunodeficiency virus antibody).
- •Known drug abuse at screening, or a positive urine drug test (morphine, methamphetamine, ketamine).
- •Average daily smoking or use of other nicotine-containing products more than 5 times per day within 90 days before screening (such as snuff, nicotine patches, nicotine gum, e-cigarettes, or nicotine inhalers).
- •Average daily alcohol intake of more than 2 units within 90 days before screening (1 unit = 10 mL ethanol, equivalent to 200 mL beer at 5% alcohol, 25 mL spirits at 40% alcohol, or 83 mL wine at 12% alcohol).
- •Average daily consumption of more than 8 cups of tea, milk tea, coffee, or caffeinated beverages within 90 days before screening (1 cup = 250 mL).
- •During admission to the clinical trial ward, inability to comply with the standardized light and moderate diet, smoking cessation (including e-cigarettes), alcohol abstinence, avoidance of any food or beverages containing alcohol, nicotine, or caffeine (such as nicotine gum, coffee, tea, milk tea, chocolate, cola, etc.), and avoidance of strenuous exercise.
研究组 & 干预措施
PAN-90806 Eye Drops, 1.0%, 10mg/mL
干预措施: PAN-90806 Ophthalmic Solution (Drug)
Vehicle Eye Drops, 0mg/mL
干预措施: Vehicle Ophthalmic Solution (Drug)
结局指标
主要结局
Corneal endothelial cell examination (density(cells/mm2)
时间窗: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Using Corneal endothelial cell analyzer for the Corneal endothelial cell examination
Corneal endothelial cell examination (coefficient of variation(% of variation in total endothelial cell size ))
时间窗: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Using Corneal endothelial cell analyzer for the Corneal endothelial cell examination
Corneal endothelial cell examination(proportion of hexagonal cells(%))
时间窗: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Using Corneal endothelial cell analyzer for the Corneal endothelial cell examination
次要结局
- Central corneal thickness (μm)(Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized))
- sodium fluorescein staining score of the cornea (NEI scale for the score)(Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized))
- Conjunctival lissamine green staining score of the cornea (NEI scale for the score)(Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized))
- Best corrected visual acuity(National standard logarithmic eye chart of China)(Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized))
- intraocular pressure measurements(mmHg)(Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized))
- slit-lamp biomicroscopy(Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized))
- non-dilated retinal photography(Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized))
- The incidence of adverse events(Day 1~Day 9)
- The severity of adverse events(Day 1~Day 9)
- blood pressure (using the portable blood pressure monitor, mmHg)(Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized))
- Pulse (using the portable blood pressure monitor, beats per minute (BPM))(Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized))
- Body temperature (Body temperature detection using infrared ear thermometer, ℃)(Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized))
- physical examination(Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized))
- electrocardiogra (Heart rate, PR interval(ms), QRS time limit(ms), QT/QTc interval(ms))(Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized))
- electrocardiogra (Heart rate)(Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized))
- electrocardiogra (PR interval(ms))(Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized))
- electrocardiogra (QT/QTc interval(ms))(Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized))