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CompletedNCT05017870Updated Aug 24, 2021

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

A Phase 1 interventional study of KSR-001 and KSR-004 in Dry Eye Syndromes, sponsored by Kukje Pharma. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-24.

Sponsored by Kukje Pharma · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Dec 2018, registered Aug 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Dry Eye Syndromes

Browse trials for

03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Kukje Pharma is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    KSR-001-01

    Participants received KSR-001-01 for 6 days.

    Drug: KSR-001

  • Experimental
    KSR-001-02

    Participants received KSR-001-02 for 6 days.

    Drug: KSR-001-02

  • Experimental
    KSR-001-03

    Participants received KSR-001-03 for 6 days.

    Drug: KSR-001-03

  • Placebo comparator
    KSR-001-04

    Participants received KSR-001-04 for 6 days.

    Drug: KSR-004

Interventions

  • DrugKSR-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

    Also known as: KSR-001-01

  • DrugKSR-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

  • DrugKSR-001-02

    KSR-001-02

  • DrugKSR-001-03

    KSR-001-03

06

What researchers measure

Primary outcomes

  1. Cmax

    Pharmacokinetic Characteristics

    Time frame: 6 days

  2. Tmax

    Pharmacokinetic Characteristics

    Time frame: 6 days

  3. t1/2

    Pharmacokinetic Characteristics

    Time frame: 6 days

07

Study locations

1 site
  • Kukje Pharma
    Seongnam-si, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05017870
Lead sponsor
Kukje Pharma
Responsible party
Sponsor
First posted
Aug 24, 2021
Start date
Dec 2, 2018
Primary completion
Jun 14, 2019
Completion
Jan 15, 2020
Last update
Aug 24, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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