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

Sponsor
Kukje Pharma (Other)
Overall Status
Completed
CT.gov ID
NCT05017870
Collaborator
(none)
24
1
4
13.4
1.8

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

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 2, 2018
Actual Primary Completion Date :
Jun 14, 2019
Actual Study Completion Date :
Jan 15, 2020

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:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Cmax [6 days]

      Pharmacokinetic Characteristics

    2. Tmax [6 days]

      Pharmacokinetic Characteristics

    3. t1/2 [6 days]

      Pharmacokinetic Characteristics

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    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.
    Responsible Party:
    Kukje Pharma
    ClinicalTrials.gov Identifier:
    NCT05017870
    Other Study ID Numbers:
    • KSR-001-P01
    First Posted:
    Aug 24, 2021
    Last Update Posted:
    Aug 24, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2021