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

NCT02924155 | Completed Phase 1

• 1 other identifier: SJSJP002_01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Event(TEAE)

  Safety/Tolerability Assessment

  Day 1(administration) to approximately Day 37(Post study visit)

Secondary Outcomes (10)

• 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)

Study Arms (2)

SJP002

EXPERIMENTAL

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

Drug: SJP002

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SJP002 DRUG

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 \[0h, 4h, 8h, 12h\])

SJP002

Placebo DRUG

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 \[0h, 4h, 8h, 12h\])

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years to 50 years (Healthy male Korean)

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Samjin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Kyung-sang Yu, M.D., Ph.D., M.B.A.

  Seoul National University College of Medicine / Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: October 5, 2016
• Study Start: September 5, 2016
• Primary Completion: November 17, 2016
• Study Completion: November 17, 2016
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

KR (1)