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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: PHP-201 0.5% ophthalmic solution (topical eye drop)

• Registration Number: NCT03586908
• Lead Sponsor: pH Pharma

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

Study Timeline

• Study Start: 2018-02-04
• Primary Completion: 2018-02-27
• Study Completion: 2018-03-09
• Study First Submitted: 2018-04-19
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-12
• Last Update Submitted: 2018-07-12
• Study First Posted: 2018-07-16
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PHP-201 0.5%	PHP-201 0.5% ophthalmic solution (topical eye drop)	PHP-201 0.5%, ophthalmic solution, topical eye drop, OU

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration [Cmax]	1week	Cmax of PHP-201 \& Metabolite
Time to Cmax[Tmax]	1week	Tmax of PHP-201 \& Metabolite

Secondary Outcome Measures

Name	Time	Method
Mean Change of Intraocular pressure(IOP)	1week	Mean Change from baseline IOP after 1week

Trial Locations

Locations (1)

Inje University Busan Baek Hospital; 🇰🇷 Busan, Busanjin-gu, Korea, Republic of