Healthy Volunteer
Conditions
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
Interventions
DRUGPHP-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
pH Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | 1week | Cmax of PHP-201 & Metabolite |
| Time to Cmax[Tmax] | 1week | Tmax of PHP-201 & Metabolite |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of Intraocular pressure(IOP) | 1week | Mean Change from baseline IOP after 1week |
Countries
South Korea
Outcome results
None listed