NCT03586908

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2018

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

23 days

First QC Date

April 19, 2018

Last Update Submit

July 12, 2018

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

  • Maximum Plasma Concentration [Cmax]

    Cmax of PHP-201 \& Metabolite

    1week

  • Time to Cmax[Tmax]

    Tmax of PHP-201 \& Metabolite

    1week

Secondary Outcomes (1)

  • Mean Change of Intraocular pressure(IOP)

    1week

Study Arms (1)

PHP-201 0.5%

EXPERIMENTAL

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

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

Interventions

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

Also known as: PHP-201 5mg/ml
PHP-201 0.5%

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Busan Baek Hospital

Busan, Busanjin-gu, 47323, South Korea

Location

MeSH Terms

Interventions

sovesudilOphthalmic Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Soojin Kim

    pH Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2018

First Posted

July 16, 2018

Study Start

February 4, 2018

Primary Completion

February 27, 2018

Study Completion

March 9, 2018

Last Updated

July 16, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)