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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-04

Study Completion Date

2018-03-09

Brief Summary

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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

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Detailed Description

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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

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Healthy Volunteer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PHP-201 0.5%

PHP-201 0.5%, ophthalmic solution, topical eye drop, OU

Group Type EXPERIMENTAL

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

Intervention Type DRUG

D1, D7: PHP-201 0.5% topical eye drop OU QD(AM), D2\~D6: PHP-201 0.5% topical eye drop OU TID

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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PHP-201 5mg/ml

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes