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Completed

NCT Number: NCT07132437

Phase I Clinical Study of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defect

One dose group of 0.004% was used.

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Key information

Conditions

Corneal Diseases Eye Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhiqiang Pan

Beijing, BJ10, China

About this study

One dose group of 0.004% was used. The whole study includes two stages: pre-test and formal test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged 18-70 (including threshold);
  • Body mass index between 19-26kg/m2 (including critical value), male weight ≥50kg, female weight ≥45kg;
  • Patients who have undergone Descemet's stripping endothelial keratoplasty（DSEK）, Descemet's stripping automated endothelial keratoplasty（DSAEK） or Descemet membrane endothelial keratoplasty（DMEK） and need to remove corneal epithelium during surgery (the diameter of the removed epithelium area ≥8mm);
  • Lacrimal secretion test (Schirmer test I) ≥10mm/5min during screening;
  • Limbus structure was normal under slit-lamp during screening period;
  • Voluntarily sign informed consent.

Exclusion criteria

  • Smoking more than 5 cigarettes per day on average;
  • suspected or indeed alcohol dependence with an average intake of more than 2 units of alcohol per day for 3 months or positive alcohol test;
  • those who have a history of drug abuse or have a positive urine test;

Treatment and study plan

ZKY001 EYE DROPS

Drug

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.

Other names: Germinal peptide eye drops

Primary outcomes

  1. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（Area Under Curve from 0 to time t（AUC 0-t）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  2. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（Area Under Curve from 0 to infinity（AUC 0-∞）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  3. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（Area Under Curve at steady state（AUC ss）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  4. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（Maximum Plasma Concentration（C max）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  5. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（Minmum Plasma Concentration（C min）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  6. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（Average Plasma Concentration（C av）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  7. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（Degree of fluctuation（FD）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  8. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（Maximum Time（T max）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  9. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（half time（T 1/2）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  10. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（apparent volume of distribution（Vd）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  11. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（elimination rate constant（Kel）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  12. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（Mean Residence Time（MRT）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  13. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（Clearance（CL）） were estimated based on plasma concentration of ZKY001 after multiple dosing

  14. Estimate pharmacokinetic parameters

    Time frame: Day 6

    Pharmacokinetic parameters（Clearance/Bioavailability（CL/F）） were estimated based on plasma concentration of ZKY001 after multiple dosing

Sponsors and collaborators

Lead sponsor

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Industry

Registry information

Official study title

Phase I Clinical Study of Systemic Pharmacokinetics and Safety of ZKY001 Eye Drops for Multiple Administration in Patients With Corneal Epithelial Defect After Corneal Endothelial Transplantation

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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