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

pH Pharma1 site in 1 country24 target enrollmentFebruary 4, 2018

ConditionsHealthy Volunteer

InterventionsPHP-201 0.5% ophthalmic solution (topical eye drop)

DrugsPHP-201 0.5% ophthalmic solution (topical eye drop)

Overview

Phase: Phase 1
Intervention: PHP-201 0.5% ophthalmic solution (topical eye drop)
Conditions: Healthy Volunteer
Sponsor: pH Pharma
Enrollment: 24
Locations: 1
Primary Endpoint: Maximum Plasma Concentration [Cmax]
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

February 4, 2018

End Date

March 9, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

pH Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Fully informed about the purpose of the study
•BMI of 18.0 kg/m² or more and 27.0 kg/m² or less who are between 19 and 50 years of age
•No congenital or chronic disease and no medically symptomatic findings

Exclusion Criteria

•Clinically significant disease history or disease history that may affect the absorption, distribution, metabolism and excretion of the drug, or ophthalmic corneal surgery
•had BCVA worse than logMAR 0.2(20/30snellen) or IOP \< 10mmHg or \>21mmHg in either eye
•Abnormalities of clinical examination (SBP, DBP, pulse rate, AST, ALT, Total bilirubin, eGFR and Serum test, ECG)
•Allergy, drug hypersensitivity and substance abuse
•Forbidden drug and diet
•Blood donation and transfusion