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

NCT07132437 | Completed Phase 1

• 1 other identifier: ZKYK-ZKY001-DYD
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

One dose group of 0.004% was used.

Conditions

Corneal Diseases

Outcome Measures

Primary Outcomes (14)

• 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

  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

  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

  Day 6

• Estimate pharmacokinetic parameters

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

  Day 6

• Estimate pharmacokinetic parameters

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

  Day 6

• Estimate pharmacokinetic parameters

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

  Day 6

• Estimate pharmacokinetic parameters

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

  Day 6

• Estimate pharmacokinetic parameters

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

  Day 6

• Estimate pharmacokinetic parameters

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

  Day 6

• Estimate pharmacokinetic parameters

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

  Day 6

• Estimate pharmacokinetic parameters

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

  Day 6

• Estimate pharmacokinetic parameters

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

  Day 6

• Estimate pharmacokinetic parameters

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

  Day 6

• Estimate pharmacokinetic parameters

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

  Day 6

Study Arms (1)

0.004% ZKY001 eye drops

EXPERIMENTAL

Start taking the medicine from Day 1 and continue for 6 consecutive days.

Drug: ZKY001 EYE DROPS

Interventions

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.

Also known as: Germinal peptide eye drops

0.004% ZKY001 eye drops

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead

Study Sites (1)

Zhiqiang Pan

Beijing, BJ10, China

Location

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Zhiqiang Pan

  Beijing Tongren Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A dose group of 0.004% was used

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: August 20, 2025
• Study Start: December 29, 2021
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

CN (1)