[KSR-001-P01]Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristic of KSR-001
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of KSR-001.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Detailed Description
After single dose, safety and local tolerability were confirmed and repeated test was conducted according to the investigator's judgment.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: KSR-001-01 Participants received KSR-001-01 for 6 days. |
Drug: KSR-001
(0 day) eye drops received one drop to both eyes once a day (1~5 day) eyedrops recieved one drop to both eyes four times a day
Other Names:
|
Experimental: KSR-001-02 Participants received KSR-001-02 for 6 days. |
Drug: KSR-001-02
KSR-001-02
|
Experimental: KSR-001-03 Participants received KSR-001-03 for 6 days. |
Drug: KSR-001-03
KSR-001-03
|
Placebo Comparator: KSR-001-04 Participants received KSR-001-04 for 6 days. |
Drug: KSR-004
(0 day) eye drops received one drop to both eyes once a day (1~5 day) eyedrops recieved one drop to both eyes four times a day
|
Outcome Measures
Primary Outcome Measures
- Cmax [6 days]
Pharmacokinetic Characteristics
- Tmax [6 days]
Pharmacokinetic Characteristics
- t1/2 [6 days]
Pharmacokinetic Characteristics
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
-
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).
-
A subject who takes drugs that induce and inhibit drug metabolises such as barbital medicines within one month before the administration of clinical trial drugs.
-
A subject who donates blood to the whole blood within 60 days before the administration of a clinical trial drug or a person who donates blood to the component within 20 days before the administration of a clinical trial drug.
-
A subject who has taken a specialty drug or herbal medicine within 14 days of administration of a clinical trial drug or a general medicine or vitamin formulation within 7 days.
-
A subject who can not continually ingest caffeine or ingest caffeine-containing foods during the period from 24 hours to discharge from hospital.
-
A subject who can not drink alcohol continuously or during the period from 24 hours to discharge from hospital.
-
A subject who can not smoke excessively or quit smoking during the period from 24 hours to discharge from hospital.
-
A subject who investigator that a tester is unsuitable for participating in clinical trials due to other reasons.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Kukje Pharma | Seongnam-si | Korea, Republic of |
Sponsors and Collaborators
- Kukje Pharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KSR-001-P01