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

Samjin Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: SJP002

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02924155

SJSJP002_01

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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
20 years to 50 years (Healthy male Korean)

Exclusion criteria

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
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
Subject who smoked more than 10 cigarettes a day on average in the last 90 days, and who cannot quit smoking during hospitalization
Man of reproductive potential not willing to use contraceptive measures during the study period
Subject not eligible for study participation in the opinion of the investigator