Healthy VolunteerPhase 1NCT03586908
PK/PD, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects
A Phase 1 study testing PHP-201 0.5% ophthalmic solution (topical eye drop) in people with Healthy Volunteer, run by pH Pharma at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- PHP-201 0.5% ophthalmic solution (topical eye drop)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Feb 2018to 9 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Inje University Busan Baek Hospital
Busan, Busanjin-gu, 47323
About this study
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
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
Read the 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
- Conditions
- Healthy Volunteer
- Being tested
- PHP-201 0.5% ophthalmic solution (topical eye drop)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHP-201 0.5% ophthalmic solution (topical eye drop)Drug
Also called PHP-201 5mg/ml
D1, D7: PHP-201 0.5% topical eye drop OU QD(AM), D2~D6: PHP-201 0.5% topical eye drop OU TID
| Study group | Role | What they receive |
|---|---|---|
| PHP-201 0.5% | Experimental | PHP-201 0.5%, ophthalmic solution, topical eye drop, OU Receives: Drug: PHP-201 0.5% ophthalmic solution (topical eye drop) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration [Cmax]
Cmax of PHP-201 \& Metabolite
Measured: 1week
Time to Cmax[Tmax]
Tmax of PHP-201 \& Metabolite
Measured: 1week
Secondary outcomes (1)
Mean Change of Intraocular pressure(IOP)
Mean Change from baseline IOP after 1week
Measured: 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start4 Feb 2018
- Primary completion27 Feb 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- pH Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soojin Kim, Study director, pH Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586908
- Sponsor's protocol ID
- PHP-201-S102
- Status last verified
- Jul 2018
- First submitted
- 19 Apr 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03586908
- Acronym / sponsor ID
- PHP-201-S102
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- pH PharmaIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2018 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PHP-201 0.5% | Experimental | Drug: PHP-201 0.5% ophthalmic solution (topical eye drop)PHP-201 0.5%, ophthalmic solution, topical eye drop, OU |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHP-201 0.5% ophthalmic solution (topical eye drop)Also: PHP-201 5mg/mlD1, D7: PHP-201 0.5% topical eye drop OU QD(AM), D2~D6: PHP-201 0.5% topical eye drop OU TID | Drug | PHP-201 0.5% |
Primary outcome
Maximum Plasma Concentration [Cmax]
Time frame: 1week
Cmax of PHP-201 \& Metabolite
Time to Cmax[Tmax]
Time frame: 1week
Tmax of PHP-201 \& Metabolite
1 secondary outcome
Mean Change of Intraocular pressure(IOP)
Time frame: 1week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soojin Kim study director
pH Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PHP-201 0.5% ophthalmic solution (topical eye drop) in people with Healthy Volunteer, run by pH Pharma at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration [Cmax] (time frame: 1week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.