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

pH Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03586908

PHP-201-S102

Details and patient eligibility

About

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

Full 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

Enrollment: 24 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

PHP-201 0.5%

Experimental group

Description:

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

Treatment:

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