Dry Eye SyndromesPhase 1NCT05017870
[KSR-001-P01]Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristic of KSR-001
A Phase 1 study testing KSR-001, KSR-004 and KSR-001-02 in people with Dry Eye Syndromes, run by Kukje Pharma at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of KSR-001. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- KSR-001, KSR-004 and KSR-001-02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Dec 2018to 15 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- A subject who can not drink alcohol continuously or during the period from 24 hours to discharge from hospital.
- A subject who can not smoke excessively or quit smoking during the period from 24 hours to discharge from hospital.
- A subject who investigator that a tester is unsuitable for participating in clinical trials due to other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Dry Eye Syndromes
- Being tested
- KSR-001, KSR-004, KSR-001-02, KSR-001-03
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSR-001Drug
Also called KSR-001-01
(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-004Drug
(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-001-02Drug
KSR-001-02
KSR-001-03Drug
KSR-001-03
| Study group | Role | What they receive |
|---|---|---|
| KSR-001-01 | Experimental | Participants received KSR-001-01 for 6 days. Receives: Drug: KSR-001 |
| KSR-001-02 | Experimental | Participants received KSR-001-02 for 6 days. Receives: Drug: KSR-001-02 |
| KSR-001-03 | Experimental | Participants received KSR-001-03 for 6 days. Receives: Drug: KSR-001-03 |
| KSR-001-04 | Placebo comparator | Participants received KSR-001-04 for 6 days. Receives: Drug: KSR-004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetic Characteristics
Measured: 6 days
Tmax
Pharmacokinetic Characteristics
Measured: 6 days
t1/2
Pharmacokinetic Characteristics
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start2 Dec 2018
- Primary completion14 Jun 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kukje Pharma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017870
- Sponsor's protocol ID
- KSR-001-P01
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05017870
- Acronym / sponsor ID
- KSR-001-P01
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kukje PharmaUniversity, hospital or other
- Study start
- 2 Dec 2018 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of KSR-001.
Detailed description
After single dose, safety and local tolerability were confirmed and repeated test was conducted according to the investigator's judgment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KSR-001-01 | Experimental | Drug: KSR-001Participants received KSR-001-01 for 6 days. |
| KSR-001-02 | Experimental | Drug: KSR-001-02Participants received KSR-001-02 for 6 days. |
| KSR-001-03 | Experimental | Drug: KSR-001-03Participants received KSR-001-03 for 6 days. |
| KSR-001-04 | Placebo comparator | Drug: KSR-004Participants received KSR-001-04 for 6 days. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KSR-001Also: KSR-001-01(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 | Drug | KSR-001-01 |
| 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 | Drug | KSR-001-04 |
| KSR-001-02KSR-001-02 | Drug | KSR-001-02 |
| KSR-001-03KSR-001-03 | Drug | KSR-001-03 |
Primary outcome
Cmax
Time frame: 6 days
Pharmacokinetic Characteristics
Tmax
Time frame: 6 days
Pharmacokinetic Characteristics
t1/2
Time frame: 6 days
Pharmacokinetic Characteristics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KSR-001, KSR-004 and KSR-001-02 in people with Dry Eye Syndromes, run by Kukje Pharma at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 6 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.