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Completed

NCT Number: NCT03586908

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

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

Completed

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Key information

Conditions

Healthy Volunteer

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inje University Busan Baek Hospital

Busan, Busanjin-gu, 47323, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: PHP-201 5mg/ml

Primary outcomes

  1. Maximum Plasma Concentration [Cmax]

    Time frame: 1week

    Cmax of PHP-201 & Metabolite

  2. Time to Cmax[Tmax]

    Time frame: 1week

    Tmax of PHP-201 & Metabolite

Secondary outcomes

  1. Mean Change of Intraocular pressure(IOP)

    Time frame: 1week

    Mean Change from baseline IOP after 1week

Sponsors and collaborators

Lead sponsor

pH Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 16, 2018
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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