Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SJP002 | Experimental | 9 subjects received single dose of SJP002 and then received multiple dose of SJP002 |
|
| Placebo | Placebo Comparator | 3 subjects received single dose of placebo and then received multiple dose of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SJP002 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Event(TEAE) | Safety/Tolerability Assessment | Day 1(administration) to approximately Day 37(Post study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the Peak Plasma Concentration (Cmax) of SJP002 | Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product. | 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 |
Not provided
Inclusion Criteria:
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
Subject with a history of drug abuse or who is positive for drugs of abuse in urine tests at screening
Subject who received any drugs such as
Subject who received other investigational products within 90 days prior to the first administration of the investigational products
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
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
Subject who smoked more than 10 cigarettes a day on average in the last 90 days, and who cannot quit smoking during hospitalization
Man of reproductive potential not willing to use contraceptive measures during the study period
Subject not eligible for study participation in the opinion of the investigator
Male
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyung-sang Yu, M.D., Ph.D., M.B.A. | Seoul National University College of Medicine / Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug |
|
|
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product |
| 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 | Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product | Period 1: Day2(predose and 0.5~24 hours postdose) |
| Measure the Time to peak drug concentration(Tmax) of SJP002 | Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product. | Period 1: Day2(predose and 0.5~24 hours postdose) |
| Measure the Half Life(t1/2) of SJP002 | Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product. | Period 1: Day2(predose and 0.5~24 hours postdose) |
| Measure the Trough Drug Concentration at steady state(Cmin,ss) of SJP002 | Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product. | 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 | Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product. | 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 | Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product. | Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose) |
| Measure the Half Life at steady state(T1/2,ss) of SJP002 | Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product. | Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose) |
| Measure the Peak Plasma Concentration Accumulation Ratio (RA,Cmax) of SJP002 | Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product. | Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose) |