[KSR-001-P01]Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristic of KSR-001

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017870
• Other study ID #: KSR-001-P01
• Status: Completed
• Phase: Phase 1
• Start date: December 2, 2018
• Est. completion date: January 15, 2020

Study information

• Verified date: August 2021
• Source: Kukje Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 15, 2020
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.

2. Body weight >= 50 kilogram and ideal body weight within the range ±20%.

3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

1. A subject who has symptoms of suspected acute disease at the time of screening.

2. Subjects with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, musculoskeletal, immune, the nose and ears, psychiatry, stomach system.

3. A subject determined to be unsuitable as a subject through a physical examined during screening.

4. A subject who is determined to be unsuitable as a subject through an ophthalmologic examination performed during screening.

5. A subject with a history of ophthalmic surgery, trauma and chronic diseases.

6. A subject who has acute or chronic eye disease requiring the use of local eye drops at the time of screening.

7. Subjects who need to wear contact lenses during clinical trial period.

8. A subject with clinically significant allergic disease.

9. A subject with a history of drug abuse.

10. 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.

11. 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).

12. 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.

13. 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.

14. 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.

15. A subject who can not continually ingest caffeine or ingest caffeine-containing foods during the period from 24 hours to discharge from hospital.

16. A subject who can not drink alcohol continuously or during the period from 24 hours to discharge from hospital.

17. A subject who can not smoke excessively or quit smoking during the period from 24 hours to discharge from hospital.

18. A subject who investigator that a tester is unsuitable for participating in clinical trials due to other reasons.

Related Conditions & MeSH terms

• Dry Eye Syndromes

Intervention

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
• 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
• KSR-001-02
KSR-001-02
• KSR-001-03
KSR-001-03

Locations

Country	Name	City	State
Korea, Republic of	Kukje Pharma	Seongnam-si

Sponsors (1)

Lead Sponsor	Collaborator
Kukje Pharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Pharmacokinetic Characteristics	6 days
Primary	Tmax	Pharmacokinetic Characteristics	6 days
Primary	t1/2	Pharmacokinetic Characteristics	6 days