NCT05017870

[KSR-001-P01]Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristic of KSR-001

A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristic of KSR-001 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Kukje Pharma · Academic / Other
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of KSR-001.

Detailed description

After single dose, safety and local tolerability were confirmed and repeated test was conducted according to the investigator's judgment.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	KSR-001	(0 day) eye drops received one drop to both eyes once a day (1\~5 day) eyedrops recieved one drop to both eyes four times a day
DRUG	KSR-004	(0 day) eye drops received one drop to both eyes once a day (1\~5 day) eyedrops recieved one drop to both eyes four times a day
DRUG	KSR-001-02	KSR-001-02
DRUG	KSR-001-03	KSR-001-03

Timeline

• Start date: 2018-12-02
• Primary completion: 2019-06-14
• Completion: 2020-01-15
• First posted: 2021-08-24
• Last updated: 2021-08-24

Locations

1 site across 1 country: South Korea