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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

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

**Inclusion Criteria:**

  1. Aged 18 to 50 years, inclusive; male or female.
  2. Body weight: males ≥50.0 kg, females ≥45.0 kg; body mass index (BMI) between 19.0 and 25.0 kg/m², inclusive.
  3. 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.
  4. At screening, best-corrected visual acuity in either eye must be ≥0.8 (decimal notation using the national standard logarithmic visual acuity chart).
  5. 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.
  6. 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.
  7. 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:**

  1. Women of childbearing potential who are pregnant or lactating; or a positive blood pregnancy test at screening (for women of childbearing potential only).
  2. Active ocular inflammation or infection in either eye at screening.
  3. History of intraocular surgery in either eye, or history of ocular laser surgery.
  4. Wearing or planning to wear corneal or scleral contact lenses within 14 days before screening or during the study period.
  5. 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.
  6. Any symptoms of respiratory tract infection within 14 days before screening (such as fever, sore throat, headache, runny nose, etc.).
  7. 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).
  8. Participation in another drug or medical device clinical trial within 90 days before screening or planned participation during the study period.
  9. Vaccination within 30 days before screening or planned vaccination during the study period.
  10. Blood donation or blood loss exceeding 200 mL within 90 days before screening.
  11. Any history of drug allergy, or known allergy at screening to any component of the investigational product or auxiliary medications required for study procedures.
  12. 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).
  13. Known drug abuse at screening, or a positive urine drug test (morphine, methamphetamine, ketamine).
  14. 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).
  15. 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).
  16. 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).
  17. 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: PAN-90806 Eye Drops, 1.0%, 10mg/mL
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.
Placebo-vergelijker: Vehicle Eye Drops, 0mg/mL
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Corneal endothelial cell examination (density(cells/mm2)
Tijdsspanne: 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
Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Corneal endothelial cell examination (coefficient of variation(% of variation in total endothelial cell size ))
Tijdsspanne: 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
Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Corneal endothelial cell examination(proportion of hexagonal cells(%))
Tijdsspanne: 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
Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Central corneal thickness (μm)
Tijdsspanne: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Central corneal thickness measurement;
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)
Tijdsspanne: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized)
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)
Tijdsspanne: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized)
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)
Tijdsspanne: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
intraocular pressure measurements(mmHg)
Tijdsspanne: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
Non-contact tonometer or rebound tonometer for the measurements
Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
slit-lamp biomicroscopy
Tijdsspanne: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
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
Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
non-dilated retinal photography
Tijdsspanne: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Use a non-mydriatic wide-angle fundus camera. No need to dilate your pupils. Follow the instructions for taking pictures.
Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
The incidence of adverse events
Tijdsspanne: Day 1~Day 9
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.
Day 1~Day 9
The severity of adverse events
Tijdsspanne: Day 1~Day 9
The severity of adverse events is divided into three levels: mild, moderate and severe.
Day 1~Day 9
blood pressure (using the portable blood pressure monitor, mmHg)
Tijdsspanne: 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)
Pulse (using the portable blood pressure monitor, beats per minute (BPM))
Tijdsspanne: 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)
Body temperature (Body temperature detection using infrared ear thermometer, ℃)
Tijdsspanne: 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)
physical examination
Tijdsspanne: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
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.
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))
Tijdsspanne: 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)
electrocardiogra (Heart rate)
Tijdsspanne: 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)
electrocardiogra (PR interval(ms))
Tijdsspanne: 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)
electrocardiogra (QT/QTc interval(ms))
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pharmacokinetic parameters
Tijdsspanne: Day 1, day 3, day 4, day 5, day 6, day7
Tmax: Time to Maximum Observed Concentration(hour)
Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
Tijdsspanne: Day 1, day 3, day 4, day 5, day 6, day7
Cmax: Maximum Observed Concentration(ng/mL)
Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
Tijdsspanne: Day 1, day 3, day 4, day 5, day 6, day7
AUC0-t: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Time Point
Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
Tijdsspanne: Day 1, day 3, day 4, day 5, day 6, day7
t1/2: Terminal Elimination Half-Life(hour)
Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
Tijdsspanne: Day 1, day 3, day 4, day 5, day 6, day7
Cmax,ss: Maximum Observed Concentration at Steady State(ng/mL)
Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
Tijdsspanne: Day 1, day 3, day 4, day 5, day 6, day7
AUCss: Area Under the Concentration-Time Curve at Steady State CL: Clearance
Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
Tijdsspanne: Day 1, day 3, day 4, day 5, day 6, day7
CL: Clearance(mL/min)
Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
Tijdsspanne: Day 1, day 3, day 4, day 5, day 6, day7
CL/F: Apparent Clearance (Clearance after Extravascular Administration, adjusted for Bioavailability) (mL/min)
Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
Tijdsspanne: Day 1, day 3, day 4, day 5, day 6, day7
DF: Degree of Fluctuation(%)
Day 1, day 3, day 4, day 5, day 6, day7

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 september 2026

Primaire voltooiing (Geschat)

30 december 2026

Studie voltooiing (Geschat)

30 december 2026

Studieregistratiedata

Eerst ingediend

22 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 augustus 2026

Eerst geplaatst (Werkelijk)

14 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

13 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • ZKO-CSP-PAN-101

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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