A Phase 1 interventional study of ZKY001 EYE DROPS in Corneal Diseases, sponsored by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. (formerly part of Lee's Pharmaceutical Limited) · Phase 1, Interventional, and Other
One dose group of 0.004% was used.
One dose group of 0.004% was used. The whole study includes two stages: pre-test and formal test.
219 studies on the registry are indexed under Corneal Diseases; 43 are open to participants now.
This study's enrollment of 3 is below the median of 40 across 132 interventional studies indexed under Corneal Diseases.
Browse Corneal Diseases studies →Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
First submitted after Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. left Lee's Pharmaceutical Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Start taking the medicine from Day 1 and continue for 6 consecutive days.
Drug: ZKY001 EYE DROPS
On the 1st postoperative day (Day1), ZKY001 eye drops were dropped into the experimental eyes (the operative eyes were taken as the experimental eyes). ZKY001 eye drops were given at 8:00 am ±1h from Day1 to Day5. 4 times a day, 1 drop each time, recommended interval of 4 to 6 hours. Day6 was administered at 8:00 am ±1h, and ZKY001 eye drops were dropped into the test eye (the surgical eye was taken as the test eye). Day6 was given only once, 1 drop each time.
Also known as: Germinal peptide eye drops
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（Area Under Curve from 0 to time t（AUC 0-t）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（Area Under Curve from 0 to infinity（AUC 0-∞）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（Area Under Curve at steady state（AUC ss）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（Maximum Plasma Concentration（C max）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（Minmum Plasma Concentration（C min）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（Average Plasma Concentration（C av）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（Degree of fluctuation（FD）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（Maximum Time（T max）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（half time（T 1/2）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（apparent volume of distribution（Vd）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（elimination rate constant（Kel）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（Mean Residence Time（MRT）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（Clearance（CL）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
Estimate pharmacokinetic parameters
Pharmacokinetic parameters（Clearance/Bioavailability（CL/F）） were estimated based on plasma concentration of ZKY001 after multiple dosing
Time frame: Day 6
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ZKY001
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. →