Clinical Study to Investigate the Systemic Exposure, Safety, and Local Tolerability of SJP002 Ophthalmic Solution in Healthy Male Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: SJP002; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SJP002; 9 subjects received single dose of SJP002 and then received multiple dose of SJP002	Drug: SJP002; 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]); Period 2 (multiple dose) - Day10~Day23: SJP002, Topical administered one drops to each eye (Administered 4 times a day [0h, 4h, 8h, 12h])
Placebo Comparator: Placebo; 3 subjects received single dose of placebo and then received multiple dose of placebo	Drug: Placebo; 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]); Period 2 (multiple dose) - Day10~Day23: Placebo, Topical administered one drops to each eye (Administered 4 times a day [0h, 4h, 8h, 12h])

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Event(TEAE)	Safety/Tolerability Assessment	Day 1(administration) to approximately Day 37(Post study visit)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Samjin Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Kyung-sang Yu, M.D., Ph.D., M.B.A., Seoul National University College of Medicine / Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2016
• Primary Completion (Actual): November 17, 2016
• Study Completion (Actual): November 17, 2016

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SJSJP002_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No