PK/PD, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects
NCT03586908 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2018-07-16
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
Conditions
- Healthy Volunteer
Interventions
- 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
Sponsors & Collaborators
-
pH Pharma
lead INDUSTRY
Principal Investigators
-
Soojin Kim · pH Pharma
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-02-04
- Primary Completion
- 2018-02-27
- Completion
- 2018-03-09
Countries
- South Korea
Study Locations
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