NCT02924155

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Samjin Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	SJP002	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 \[0h, 4h, 8h, 12h\])
DRUG	Placebo	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 \[0h, 4h, 8h, 12h\])

Timeline

• Start date: 2016-09-05
• Primary completion: 2016-11-17
• Completion: 2016-11-17
• First posted: 2016-10-05
• Last updated: 2022-04-14

Locations

1 site across 1 country: South Korea