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

NCT05017870 | Completed Phase 1 DMC

• 1 other identifier: KSR-001-P01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (3)

• Cmax

  Pharmacokinetic Characteristics

  6 days

• Tmax

  Pharmacokinetic Characteristics

  6 days

• t1/2

  Pharmacokinetic Characteristics

  6 days

Study Arms (4)

KSR-001-01

EXPERIMENTAL

Participants received KSR-001-01 for 6 days.

Drug: KSR-001

KSR-001-02

EXPERIMENTAL

Participants received KSR-001-02 for 6 days.

Drug: KSR-001-02

KSR-001-03

EXPERIMENTAL

Participants received KSR-001-03 for 6 days.

Drug: KSR-001-03

KSR-001-04

PLACEBO COMPARATOR

Participants received KSR-001-04 for 6 days.

Drug: KSR-004

Interventions

KSR-001 DRUG

(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

KSR-001-01

KSR-004 DRUG

(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-001-04

KSR-001-02 DRUG

KSR-001-02

KSR-001-02

KSR-001-03 DRUG

KSR-001-03

KSR-001-03

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kukje Pharma: lead

Study Sites (1)

Kukje Pharma

Seongnam-si, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 24, 2021
• Study Start: December 2, 2018
• Primary Completion: June 14, 2019
• Study Completion: January 15, 2020
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

KR (1)