NCT03662971

Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers

Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers.

Detailed description

The subjects enrolled in this study are healthy volunteers, divided into single dose groups and multiple doses groups with dose escalation.The study is designed to assign the subjects to five single-dose groups from low to high (0.0005%, 0.001%, 0.002%, 0.004% and 0.008%), and three multiple-dose groups (0.002%, 0.004% and 0.008%), with both male and female subjects in each group. This clinical trial is a double-blind design.

Conditions

• Corneal Defect

Interventions

Type	Name	Description
DRUG	Germinal peptide eye drops	Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%

Timeline

• Start date: 2018-10-29
• Primary completion: 2018-12-04
• Completion: 2019-10-24
• First posted: 2018-09-10
• Last updated: 2020-02-05

Locations

1 site across 1 country: China