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

Healthy Volunteer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586908
• Other study ID #: PHP-201-S102
• Status: Completed
• Phase: Phase 1
• Start date: February 4, 2018
• Est. completion date: March 9, 2018

Study information

• Verified date: July 2018
• Source: pH Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 9, 2018
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• PHP-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

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Baek Hospital	Busan	Busanjin-gu

Sponsors (1)

Lead Sponsor	Collaborator
pH Pharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration [Cmax]	Cmax of PHP-201 & Metabolite	1week
Primary	Time to Cmax[Tmax]	Tmax of PHP-201 & Metabolite	1week
Secondary	Mean Change of Intraocular pressure(IOP)	Mean Change from baseline IOP after 1week	1week