Clinical trial NCT02924155: Clinical Study to Investigate the Systemic Exposure, Safety, and Local Tolerability of SJP002 Ophthalmic Solution in Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Samjin Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. 20 years to 50 years (Healthy male Korean)

Exclusion Criteria:

1. 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.
2. Subject with a history of clinically significant hypersensitivity or hypersensitivity reactions to drugs (aspirin, antibiotics, etc.)
3. 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
4. Subject with a history of drug abuse or who is positive for drugs of abuse in urine tests at screening
5. Subject who received any drugs such as

   * Prescription drug or herbal medicine within 14 days prior to the first administration of the investigational products
   * Over the counter (OTC) or vitamin within 7 days prior to the first administration of the investigational products
6. Subject who received other investigational products within 90 days prior to the first administration of the investigational products
7. Subject who have donated whole blood within 60 days prior to the first administration of the investigational products, or donated component blood or have received blood transfusion within 30 days prior to the first administration of the investigational products
8. Subject who continuously drink alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol during the study period
9. Subject who smoked more than 10 cigarettes a day on average in the last 90 days, and who cannot quit smoking during hospitalization
10. Man of reproductive potential not willing to use contraceptive measures during the study period
11. Subject not eligible for study participation in the opinion of the investigator

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Event(TEAE)
timeFrame: Day 1(administration) to approximately Day 37(Post study visit)
Secondary outcomes:
measure: Measure the Peak Plasma Concentration (Cmax) of SJP002
timeFrame: Period 1: Day2(predose and 0.5~24 hours postdose)
measure: Measure the Area Under the plasma concentration versus time Curve from the first observed to last(AUClast) of SJP002
timeFrame: Period 1: Day2(predose and 0.5~24 hours postdose)
measure: Measure the Area Under the plasma concentration versus time Curve from the first sampled data extrapolated to infinity(AUCinf) of SJP002
timeFrame: Period 1: Day2(predose and 0.5~24 hours postdose)
measure: Measure the Time to peak drug concentration(Tmax) of SJP002
timeFrame: Period 1: Day2(predose and 0.5~24 hours postdose)
measure: Measure the Half Life(t1/2) of SJP002
timeFrame: Period 1: Day2(predose and 0.5~24 hours postdose)
measure: Measure the Trough Drug Concentration at steady state(Cmin,ss) of SJP002
timeFrame: Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose)
measure: Measure the Area Under the plasma concentration-time Curve over a dosing interval at steady state(AUCtau,ss) of SJP002
timeFrame: Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose)
measure: Measure the Time to peak drug concentration at steady state(Tmax,ss) of SJP002
timeFrame: Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose)
measure: Measure the Half Life at steady state(T1/2,ss) of SJP002
timeFrame: Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose)
measure: Measure the Peak Plasma Concentration Accumulation Ratio (RA,Cmax) of SJP002
timeFrame: Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine / Seoul National University Hospital
name: Kyung-sang Yu, M.D., Ph.D., M.B.A.
role: PRINCIPAL_INVESTIGATOR
References: