A Phase 1 interventional study of SJP002 and Placebo in Healthy, sponsored by Samjin Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by Samjin Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Other
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.
Samjin Pharmaceutical Co., Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject with a disease history of any clinically significant condition as below.
Subject with a disease history of any ophthalmic condition as below
Subject who received any drugs such as
9 subjects received single dose of SJP002 and then received multiple dose of SJP002
Drug: SJP002
3 subjects received single dose of placebo and then received multiple dose of placebo
Drug: Placebo
1. Period 1 (single dose) * Day1: Placebo, Topical administered one drop to each eye (Once a day) * Day2: SJP002, Topical administered one drops to each eye (Once a day) * Day3: SJP002, Topical administered one drops to each eye (Administered 4 times a day \[0h, 4h, 8h, 12h\]) 2. Period 2 (multiple dose) - Day10\~Day23: SJP002, Topical administered one drops to each eye (Administered 4 times a day \[0h, 4h, 8h, 12h\])
1. Period 1 (single dose) * Day1: Placebo, Topical administered one drop to each eye (Once a day) * Day2: Placebo, Topical administered one drops to each eye (Once a day) * Day3 Placebo, Topical administered one drops to each eye (Administered 4 times a day \[0h, 4h, 8h, 12h\]) 2. Period 2 (multiple dose) - Day10\~Day23: Placebo, Topical administered one drops to each eye (Administered 4 times a day \[0h, 4h, 8h, 12h\])
Incidence of Treatment Emergent Adverse Event(TEAE)
Safety/Tolerability Assessment
Time frame: Day 1(administration) to approximately Day 37(Post study visit)
Measure the Peak Plasma Concentration (Cmax) of SJP002
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Time frame: 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
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Period 2: Day10(predose), Day23(predose and 0.5~24 hours postdose)
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Samjin Pharmaceutical Co., Ltd.