Evaluation of PAN-90806 Eye Drops in Healthy Subjects
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorZhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PAN-90806 Ophthalmic Solution
DrugThe 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 Ophthalmic Solution
DrugThe 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: PAN-90806 Eye Drops, 1.0%, 10mg/mLExperimental treatment 1 intervention
Group B: Vehicle Eye Drops, 0mg/mLPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Corneal endothelial cell examination (density(cells/mm2)
Using Corneal endothelial cell analyzer for the Corneal endothelial cell examination
Time frame
Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)2
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
Time frame
Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)3
Corneal endothelial cell examination(proportion of hexagonal cells(%))
Using Corneal endothelial cell analyzer for the Corneal endothelial cell examination
Time frame
Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)Secondary outcomes
1
Central corneal thickness (μm)
Central corneal thickness measurement;
Time frame
Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)2
sodium fluorescein staining score of the cornea (NEI scale for the score)
Time frame
Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized)3
Conjunctival lissamine green staining score of the cornea (NEI scale for the score)
Time frame
Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized)4
Best corrected visual acuity(National standard logarithmic eye chart of China)
Time frame
Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)Other outcomes
1
Pharmacokinetic parameters
Tmax: Time to Maximum Observed Concentration(hour)
Time frame
Day 1, day 3, day 4, day 5, day 6, day72
Pharmacokinetic parameters
Cmax: Maximum Observed Concentration(ng/mL)
Time frame
Day 1, day 3, day 4, day 5, day 6, day73
Pharmacokinetic parameters
AUC0-t: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Time Point
Time frame
Day 1, day 3, day 4, day 5, day 6, day74
Pharmacokinetic parameters
t1/2: Terminal Elimination Half-Life(hour)
Time frame
Day 1, day 3, day 4, day 5, day 6, day7Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Lead sponsor
The Second Hospital of Anhui Medical University
Collaborator
Source ClinicalTrials.gov
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