NCT03586908

PK/PD, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects

An Open Label, Multiple-dose, Phase 1 Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: pH Pharma · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

An open label, multiple-dose, phase 1 clinical trial to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of PHP-201 topical eye drop in Korean and Japanese healthy subjects

Detailed description

Primary: The evaluation of pharmacokinetic properties of repeating PHP-201 topical eye drop Secondary: The evaluation of pharmacodynamic, safety and tolerability of repeating PHP-201 topical eye drop

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	PHP-201 0.5% ophthalmic solution (topical eye drop)	D1, D7: PHP-201 0.5% topical eye drop OU QD(AM), D2\~D6: PHP-201 0.5% topical eye drop OU TID

Timeline

• Start date: 2018-02-04
• Primary completion: 2018-02-27
• Completion: 2018-03-09
• First posted: 2018-07-16
• Last updated: 2018-07-16

Locations

1 site across 1 country: South Korea