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

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: KSR-001; Drug: KSR-001-02; Drug: KSR-001-03; Drug: KSR-004

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Kukje Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / 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: KSR-001-01
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Pharmacokinetic Characteristics	6 days
Tmax	Pharmacokinetic Characteristics	6 days
t1/2	Pharmacokinetic Characteristics	6 days

Collaborators and Investigators

• Sponsor: Kukje Pharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2018
• Primary Completion (ACTUAL): June 14, 2019
• Study Completion (ACTUAL): January 15, 2020

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (ACTUAL): August 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: KSR-001-P01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No