A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristic of KSR-001 in Healthy Male Volunteers

Kukje Pharma1 site in 1 country24 target enrollmentDecember 2, 2018

Overview

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of KSR-001.

After single dose, safety and local tolerability were confirmed and repeated test was conducted according to the investigator's judgment.

Registry

clinicaltrials.gov

Start Date

December 2, 2018

End Date

January 15, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Sponsor

Kukje Pharma

Responsible Party

Sponsor

•Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.
•Body weight \>= 50 kilogram and ideal body weight within the range ±20%.
•Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

•A subject who has symptoms of suspected acute disease at the time of screening.
•Subjects with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, musculoskeletal, immune, the nose and ears, psychiatry, stomach system.
•A subject determined to be unsuitable as a subject through a physical examined during screening.
•A subject who is determined to be unsuitable as a subject through an ophthalmologic examination performed during screening.
•A subject with a history of ophthalmic surgery, trauma and chronic diseases.
•A subject who has acute or chronic eye disease requiring the use of local eye drops at the time of screening.
•Subjects who need to wear contact lenses during clinical trial period.
•A subject with clinically significant allergic disease.
•A subject with a history of drug abuse.
•History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.