- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07764965
Evaluation of PAN-90806 Eye Drops in Healthy Subjects
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
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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:
Receive PAN-90806 eye drops or placebo eye drops once daily in both eyes, with 1 drop per eye, on Day 1 and on Days 3 through 7, for a total of 6 dosing days Be admitted to the clinical research unit and remain under inpatient observation during the treatment period Have all doses administered by study staff; self-administration will not be allowed Use single-dose preservative-free study medication containers, which will be discarded immediately after use Follow study restrictions during inpatient stay, including controlled meals, no smoking, no alcohol, no nicotine-containing products, no caffeine-containing foods or drinks, and no strenuous exercise Undergo intensive blood sampling for systemic pharmacokinetic assessment, with a total of 31 blood collection time points and approximately 155 mL of blood collected Complete ophthalmic and general safety assessments, including corneal endothelial cell examination, central corneal thickness, fluorescein corneal staining, lissamine green conjunctival staining, best corrected visual acuity, intraocular pressure, slit-lamp biomicroscopy, non-mydriatic fundus photography, laboratory tests, vital signs, physical examinations, ECGs, and adverse event monitoring The pharmacokinetic endpoints include Tmax, Cmax, AUC0-t, t1/2, Cmax,ss, AUCss, CL or CL/F, and DF. Safety and tolerability will be assessed through ocular examinations, laboratory evaluations, vital signs, ECGs, physical examinations, and the incidence and severity of ocular and systemic adverse events, including events of special interest.
Eligible participants must be healthy adults 18 to 50 years of age who meet specified body weight, BMI, ocular health, and general health requirements. Participants with clinically significant eye disease, recent surgery, relevant medical conditions, recent medication use, positive infectious disease screening, substance abuse, or other factors that may interfere with study safety or pharmacokinetic evaluation will be excluded.
Overall, this study is intended to provide an early clinical assessment of PAN-90806 eye drops in healthy volunteers by characterizing their safety profile and systemic pharmacokinetics after repeated bilateral ocular dosing under closely monitored inpatient conditions.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Wei Hu, Medical Doctor
- Número de teléfono: (+86)13856086475
- Correo electrónico: officegcp@ayefy.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
**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 ≤3.
- 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.
**Exclusion Criteria:**
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PAN-90806 Eye Drops, 1.0%, 10mg/mL
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The medication was administered at 9:00am every morning on Day 1 and Day 3-Day 7 of hospitalization.
Each time, the medication is administered to both eyes, 1 drop per eye, for a total of 6 days of treatment.
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Comparador de placebos: Vehicle Eye Drops, 0mg/mL
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The medication was administered at 9:00am every morning on Day 1 and Day 3-Day 7 of hospitalization.
Each time, the medication is administered to both eyes, 1 drop per eye, for a total of 6 days of treatment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Corneal endothelial cell examination (density(cells/mm2)
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Using Corneal endothelial cell analyzer for the Corneal endothelial cell examination
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Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Corneal endothelial cell examination (coefficient of variation(% of variation in total endothelial cell size ))
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Using Corneal endothelial cell analyzer for the Corneal endothelial cell examination
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Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Corneal endothelial cell examination(proportion of hexagonal cells(%))
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Using Corneal endothelial cell analyzer for the Corneal endothelial cell examination
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Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Central corneal thickness (μm)
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Central corneal thickness measurement;
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Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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sodium fluorescein staining score of the cornea (NEI scale for the score)
Periodo de tiempo: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized)
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Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized)
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Conjunctival lissamine green staining score of the cornea (NEI scale for the score)
Periodo de tiempo: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized)
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Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized)
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Best corrected visual acuity(National standard logarithmic eye chart of China)
Periodo de tiempo: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
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Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
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intraocular pressure measurements(mmHg)
Periodo de tiempo: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
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Non-contact tonometer or rebound tonometer for the measurements
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Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
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slit-lamp biomicroscopy
Periodo de tiempo: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
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The eyelids, conjunctiva, cornea, iris, anterior chamber, lens and other parts were observed through the slit lamp, and the researchers Determine whether the test results are abnormal and have clinical significance
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Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
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non-dilated retinal photography
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Use a non-mydriatic wide-angle fundus camera.
No need to dilate your pupils.
Follow the instructions for taking pictures.
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Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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The incidence of adverse events
Periodo de tiempo: Day 1~Day 9
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Adverse events are coded using the Chinese version of MedDRA 29.0 and above.
Adverse events (TEAEs) and adverse reactions that occurred during treatment were summarized according to system organ classification (SOC) and preferred term (PT), and the number, occurrence and percentage of all volunteers who experienced TEAEs and adverse reactions were counted.
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Day 1~Day 9
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The severity of adverse events
Periodo de tiempo: Day 1~Day 9
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The severity of adverse events is divided into three levels: mild, moderate and severe.
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Day 1~Day 9
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blood pressure (using the portable blood pressure monitor, mmHg)
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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The researcher will determine whether the test results are abnormal and have clinical significance.
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Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Pulse (using the portable blood pressure monitor, beats per minute (BPM))
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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The researcher will determine whether the test results are abnormal and have clinical significance.
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Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Body temperature (Body temperature detection using infrared ear thermometer, ℃)
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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The researcher will determine whether the test results are abnormal and have clinical significance.
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Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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physical examination
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Physical examination, including skin, lymph nodes, head and neck, chest, abdomen, spine and extremities, nervous system and others.
The researcher will judge whether the test results are abnormal and have clinical significance.
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Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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electrocardiogra (Heart rate, PR interval(ms), QRS time limit(ms), QT/QTc interval(ms))
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
|
The researcher will determine whether the test results are abnormal and have clinical significance.
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Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
|
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electrocardiogra (Heart rate)
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
|
The researcher will determine whether the test results are abnormal and have clinical significance.
|
Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
|
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electrocardiogra (PR interval(ms))
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
|
The researcher will determine whether the test results are abnormal and have clinical significance.
|
Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
|
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electrocardiogra (QT/QTc interval(ms))
Periodo de tiempo: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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The researcher will determine whether the test results are abnormal and have clinical significance.
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Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pharmacokinetic parameters
Periodo de tiempo: Day 1, day 3, day 4, day 5, day 6, day7
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Tmax: Time to Maximum Observed Concentration(hour)
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Day 1, day 3, day 4, day 5, day 6, day7
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Pharmacokinetic parameters
Periodo de tiempo: Day 1, day 3, day 4, day 5, day 6, day7
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Cmax: Maximum Observed Concentration(ng/mL)
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Day 1, day 3, day 4, day 5, day 6, day7
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Pharmacokinetic parameters
Periodo de tiempo: Day 1, day 3, day 4, day 5, day 6, day7
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AUC0-t: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Time Point
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Day 1, day 3, day 4, day 5, day 6, day7
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Pharmacokinetic parameters
Periodo de tiempo: Day 1, day 3, day 4, day 5, day 6, day7
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t1/2: Terminal Elimination Half-Life(hour)
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Day 1, day 3, day 4, day 5, day 6, day7
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Pharmacokinetic parameters
Periodo de tiempo: Day 1, day 3, day 4, day 5, day 6, day7
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Cmax,ss: Maximum Observed Concentration at Steady State(ng/mL)
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Day 1, day 3, day 4, day 5, day 6, day7
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Pharmacokinetic parameters
Periodo de tiempo: Day 1, day 3, day 4, day 5, day 6, day7
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AUCss: Area Under the Concentration-Time Curve at Steady State CL: Clearance
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Day 1, day 3, day 4, day 5, day 6, day7
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Pharmacokinetic parameters
Periodo de tiempo: Day 1, day 3, day 4, day 5, day 6, day7
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CL: Clearance(mL/min)
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Day 1, day 3, day 4, day 5, day 6, day7
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Pharmacokinetic parameters
Periodo de tiempo: Day 1, day 3, day 4, day 5, day 6, day7
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CL/F: Apparent Clearance (Clearance after Extravascular Administration, adjusted for Bioavailability) (mL/min)
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Day 1, day 3, day 4, day 5, day 6, day7
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Pharmacokinetic parameters
Periodo de tiempo: Day 1, day 3, day 4, day 5, day 6, day7
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DF: Degree of Fluctuation(%)
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Day 1, day 3, day 4, day 5, day 6, day7
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ZKO-CSP-PAN-101
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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