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

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 5, 2016

Primary Completion Date

November 17, 2016

Study Completion Date

November 17, 2016

Conditions
Healthy
Interventions
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 \[0h, 4h, 8h, 12h\])"

Trial Locations (1)

Unknown

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Samjin Pharmaceutical Co., Ltd.

INDUSTRY

NCT02924155 - Clinical Study to Investigate the Systemic Exposure, Safety, and Local Tolerability of SJP002 Ophthalmic Solution in Healthy Male Volunteers | Biotech Hunter | Biotech Hunter