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

NCT02924155 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-04-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Samjin Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-sang Yu, M.D., Ph.D., M.B.A. · Seoul National University College of Medicine / Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-05
Primary Completion
2016-11-17
Completion
2016-11-17

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02924155 on ClinicalTrials.gov