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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

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

**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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore placebo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Corneal endothelial cell examination (density(cells/mm2)
Lasso di tempo: 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 ))
Lasso di tempo: 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(%))
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Central corneal thickness (μm)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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))
Lasso di tempo: 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, ℃)
Lasso di tempo: 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
Lasso di tempo: 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))
Lasso di tempo: 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)
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Pharmacokinetic parameters
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 settembre 2026

Completamento primario (Stimato)

30 dicembre 2026

Completamento dello studio (Stimato)

30 dicembre 2026

Date di iscrizione allo studio

Primo inviato

22 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 agosto 2026

Primo Inserito (Effettivo)

14 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • ZKO-CSP-PAN-101

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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