NCT03967548

The Germinal Peptide Eye Drops in Healthy Volunteers in a Clinical Study

To Evaluate the Local Pharmacokinetic Characteristics of Single Administration of Germinal Peptide Eye Drops in Healthy Volunteers in a Phase I Clinical Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The subjects of this study were healthy subjects, who were given medicine in a single dose group: 0.004%.

Detailed description

Tear collection was conducted on the single dose D1 (that is, the day of administration). Collection points: 10 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, and 12 h after administration.Each time 5-50 mg (generally 20 mg), a total of 160-1600 mg of tears will be collected (during the screening period, all subjects will retain the tear samples collected by the Schirmer filter paper, among which, qualified tear samples will be used for blank samples or methodological investigation.After administration, only 1 tear collection site will be collected for each subject.

Conditions

• Corneal Defect

Interventions

Type	Name	Description
DRUG	Germinal peptide eye drops	Germinal peptide eye drops of 0.004%

Timeline

• Start date: 2021-04-09
• Primary completion: 2021-05-16
• Completion: 2021-06-15
• First posted: 2019-05-30
• Last updated: 2021-09-17

Locations

1 site across 1 country: China