Evaluation of PAN-90806 Eye Drops in Healthy Subjects

NCT07764965 | Not Yet Recruiting Phase 1

• 1 other identifier: ZKO-CSP-PAN-101
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Wet Age Related Macular Degeneration; Neovascular (Wet) Age-Related Macular Degeneration

Keywords

PAN-90806; Zhaoke; nAMD; Wet AMD

Outcome Measures

Primary Outcomes (3)

• Corneal endothelial cell examination (density(cells/mm2)

  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 ))

  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(%))

  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)

Secondary Outcomes (17)

• 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)

Other Outcomes (9)

• Pharmacokinetic parameters

  Day 1, day 3, day 4, day 5, day 6, day7

• Pharmacokinetic parameters

  Day 1, day 3, day 4, day 5, day 6, day7

• Pharmacokinetic parameters

  Day 1, day 3, day 4, day 5, day 6, day7

Study Arms (2)

PAN-90806 Eye Drops, 1.0%, 10mg/mL

EXPERIMENTAL

Drug: PAN-90806 Ophthalmic Solution

Vehicle Eye Drops, 0mg/mL

PLACEBO COMPARATOR

Drug: Vehicle Ophthalmic Solution

Interventions

PAN-90806 Ophthalmic Solution DRUG

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.

PAN-90806 Eye Drops, 1.0%, 10mg/mL

Vehicle Ophthalmic Solution DRUG

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.

Vehicle Eye Drops, 0mg/mL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead
• The Second Hospital of Anhui Medical University: collaborator

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Wei Hu, Medical Doctor

CONTACT

(+86)13856086475; officegcp@ayefy.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share