A Randomized, Double-blind, Placebo-controlled, Single Day/Multiple Day Dosing, Phase I Clinical Trial to Investigate the Systemic Exposure, Safety and Local Tolerability of SJP002 Ophthalmic Solution in Healthy Korean Male Subjects

Samjin Pharmaceutical Co., Ltd.1 site in 1 country12 target enrollmentSeptember 5, 2016

ConditionsHealthy

InterventionsSJP002 Placebo

DrugsSJP002 Placebo

Overview

Phase: Phase 1
Intervention: SJP002
Conditions: Healthy
Sponsor: Samjin Pharmaceutical Co., Ltd.
Enrollment: 12
Locations: 1
Primary Endpoint: Incidence of Treatment Emergent Adverse Event(TEAE)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase1, single center, double-blind, placebo control, randomized study and consisted of single dosing(period 1) and multiple dosing(period 2).

In this clinical trial, safety and local tolerability are evaluated for 7 days after single dosing of the investigational product. If multiple dosing is judged to be acceptable as a result of single dosing evaluation (safety and local tolerability evaluation including ophthalmic examination), multiple dosing starts from Day 8(7 days after the single dosing) for 14 days. Safety and local tolerability, including ophthalmic symptom assessment, should be evaluated during the multiple dosing period.

Registry

clinicaltrials.gov

Start Date

September 5, 2016

End Date

November 17, 2016

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Samjin Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study
•20 years to 50 years (Healthy male Korean)

Exclusion Criteria

•Subject with a disease history of any clinically significant condition as below.
•Liver, Kidney, nervous system, immune system, respiratory system, endocrine system, tumor, cardiovascular disease or mental illness (mood disorder or obsessive-compulsive disorder etc.) etc.
•Subject with a history of clinically significant hypersensitivity or hypersensitivity reactions to drugs (aspirin, antibiotics, etc.)
•Subject with a disease history of any ophthalmic condition as below
•History of or suspected symptoms or signs of vision problems, including keratitis, uveitis, retinitis, dry eye syndrome, and strabismus.
•Corrected eyesight measured at screening is 20/40 or less
•Those who have previously had ophthalmic surgery. (Exceptional case: in the case of having ophthalmic laser surgery before 6 months from the screening)
•Those who have experienced side effects after wearing contact lenses, those who have worn contact lenses within the last month, or those who cannot ban wearing contact lens during the clinical trial
•Abnormal findings in other ophthalmic examinations
•Subject with a history of drug abuse or who is positive for drugs of abuse in urine tests at screening

Arms & Interventions

SJP002

9 subjects received single dose of SJP002 and then received multiple dose of SJP002

Intervention: SJP002

Placebo

3 subjects received single dose of placebo and then received multiple dose of placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of Treatment Emergent Adverse Event(TEAE)

Time Frame: Day 1(administration) to approximately Day 37(Post study visit)

Safety/Tolerability Assessment

Secondary Outcomes

Measure the Peak Plasma Concentration (Cmax) of SJP002(Period 1: Day2(predose and 0.5~24 hours postdose))
Measure the Area Under the plasma concentration versus time Curve from the first observed to last(AUClast) of SJP002(Period 1: Day2(predose and 0.5~24 hours postdose))
Measure the Area Under the plasma concentration versus time Curve from the first sampled data extrapolated to infinity(AUCinf) of SJP002(Period 1: Day2(predose and 0.5~24 hours postdose))
Measure the Time to peak drug concentration(Tmax) of SJP002(Period 1: Day2(predose and 0.5~24 hours postdose))
Measure the Half Life(t1/2) of SJP002(Period 1: Day2(predose and 0.5~24 hours postdose))
Measure the Trough Drug Concentration at steady state(Cmin,ss) of SJP002(Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose))
Measure the Area Under the plasma concentration-time Curve over a dosing interval at steady state(AUCtau,ss) of SJP002(Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose))
Measure the Time to peak drug concentration at steady state(Tmax,ss) of SJP002(Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose))
Measure the Half Life at steady state(T1/2,ss) of SJP002(Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose))
Measure the Peak Plasma Concentration Accumulation Ratio (RA,Cmax) of SJP002(Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose))