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

NCT ID: NCT02924155

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-05
• Study Completion Date: 2016-11-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

SJP002

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

Group Type: EXPERIMENTAL

SJP002

Intervention Type: 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])

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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])

Interventions

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])

Intervention Type: 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])

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

2. 20 years to 50 years (Healthy male Korean)

Exclusion Criteria

1. 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.

2. Subject with a history of clinically significant hypersensitivity or hypersensitivity reactions to drugs (aspirin, antibiotics, etc.)

3. 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

4. Subject with a history of drug abuse or who is positive for drugs of abuse in urine tests at screening

5. 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

6. Subject who received other investigational products within 90 days prior to the first administration of the investigational products

7. 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

8. 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

9. Subject who smoked more than 10 cigarettes a day on average in the last 90 days, and who cannot quit smoking during hospitalization

10. Man of reproductive potential not willing to use contraceptive measures during the study period

11. Subject not eligible for study participation in the opinion of the investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samjin Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung-sang Yu, M.D., Ph.D., M.B.A.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine / Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SJSJP002_01

Identifier Type: -

Identifier Source: org_study_id