XerophthalmiaPhase 1NCT06263998
Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops
A Phase 1 study testing NCP112 in people with Xerophthalmia, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
The objective is to evaluate the safety, local tolerability, and pharmacokinetics of NCP112 eye drops through single and multiple dose-escalation ocular administrations in healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Xerophthalmia
- What is being tested?
- NCP112
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jul 2024to 30 Jan 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult subjects aged 19 to 50 years at the time of screening (Visit 1).
- Subjects with a body weight of 50.0 kg or more, and a body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of screening (Visit 1).
- ※ Body Mass Index (BMI, kg/m²) = Weight (kg) / [Height (m)]²
- Subjects who have received sufficient explanation about the clinical trial, fully understand it, and have voluntarily decided to participate and signed the written informed consent.
- Subjects deemed suitable as participants for this clinical trial based on the investigators judgment after physical examination, clinical laboratory tests, and medical history obtained during screening (Visit 1).
Who cannot join
- Subjects with clinically significant diseases or history of diseases related to the liver, kidneys, cardiovascular system, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system (such as epilepsy, mood disorders, obsessive-compulsive disorder), hematologic/oncologic system, or urinary system (chronic or recurrent urinary tract infections).
- Subjects with hepatitis B or C.
- Subjects meeting any of the following criteria based on ophthalmologic history or examination during screening (Visit 1):
- Corrected visual acuity of 20/40 or less.
- Intraocular pressure exceeding 21 mmHg in either eye.
- History of lacrimal drainage system disease or abnormal tear drainage.
Show all 32Show fewer
- History or suspicion of conditions affecting visual organs such as keratitis, iritis, uveitis, retinitis, dry eye syndrome, strabismus, glaucoma, etc.
- Experience of adverse effects from contact lens use, or contact lens use within one month prior to the anticipated first dose, or inability to abstain from contact lens use during the clinical trial.
- Ophthalmologic surgery (intraocular surgery) or laser vision correction surgery (such as LASIK) within 12 months prior to the anticipated first dose.
- Silicone punctal occlusion or punctal cauterization within 3 months prior to the anticipated first dose (collagen punctal occlusion within 1 month).
- Any other abnormal findings from ophthalmologic examination.
- Subjects with a history of hypersensitivity to the active ingredients or excipients of the investigational drug, or to drugs in the same class as the active ingredients.
- Subjects who have taken any medications related to dry eye syndrome (e.g., artificial tears, anti-inflammatory agents like cyclosporine, hyaluronic acid preparations, tetracycline preparations) or drugs that could induce dry eye syndrome or affect the outcome of this clinical trial (e.g., oral contraceptives, antihistamines, sedatives, oral aspirin, corticosteroids) within one month prior to the anticipated first dose.
- Subjects who have taken any prescription drugs, eye drops other than those for dry eye, oriental medicine, or any other health supplements, including liver function supplements or vitamins within 2 weeks of the expected first dosing date, or any over-the-counter drugs within 1 week (unless other conditions are deemed appropriate by the investigator).
- Subjects who have taken drug metabolism inducers or inhibitors, such as barbiturates, within one month prior to the expected first dosing date
- Subjects with a history of drug abuse or a positive result on a urine drug test at screening (Visit 1).
- Subjects unable to restrict grapefruit or grapefruit-containing food consumption from 7 days prior to the anticipated first dose through the duration of the clinical trial.
- Subjects with systolic blood pressure of 90 mmHg or less, or 140 mmHg or more, or diastolic blood pressure of 50 mmHg or less, or 90 mmHg or more after sitting for at least 3 minutes without sudden postural changes during screening (Visit 1).
- Subjects with a history of alcohol abuse, or who have consumed alcohol regularly (more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) within one month prior to the anticipated first dose, or are unable to abstain from alcohol during the clinical trial.
- Subjects who regularly consume caffeine (e.g., coffee or green tea more than 5 units/day) or are unable to abstain from caffeine-containing foods from 24 hours prior to hospitalization through the duration of the clinical trial.
- Subjects who have regularly smoked (including e-cigarettes, more than 10 cigarettes/day) within one month prior to the anticipated first dose, or are unable to abstain from smoking during the clinical trial.
- Subjects who test positive on a breath alcohol test at screening (Visit 1).
- Subjects who have participated in another clinical trial and received an investigational drug within 6 months prior to the anticipated first dose.
- Subjects who have donated whole blood within 2 months, or component blood within 1 month, or received a blood transfusion within 1 month prior to the anticipated first dose, or who plan to donate or receive blood during the clinical trial.
- Subjects who have received a vaccine within 14 days prior to the anticipated first dose or are expected to receive a vaccine during the trial period.
- Female participants who test positive on a pregnancy test (urine hCG) conducted before the start of investigational drug administration, are pregnant, or are breastfeeding, except for those who have undergone surgical sterilization (Bilateral tubal ligation, Bilateral oophorectomy, or Hysterectomy).
- Subjects who, during the entire clinical trial period and for at least 90 days after the last dose of the investigational drug, cannot or do not agree to use medically acceptable double contraception methods, or whose partner cannot or does not agree to use medically acceptable contraception, or who do not agree to refrain from donating sperm during this period.
- ※ Medically acceptable contraception methods include:
- Use of an intrauterine device (IUD) with a documented failure rate by the partner.
- Double contraception (use of barrier methods by both male and female partners).
- Surgical sterilization of the subject or partner (vasectomy, tubal ligation, hysterectomy).
- Subjects deemed unsuitable for participation by the investigator for other reasons (e.g., non-compliance with instructions).
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Daehak-ro, Jongno-gu, 03080
INJIN JANG, MD, PH.D
About this study
Official title: A Randomized, Double-blind, Parallel, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Clinical Study to Assess the Safety, and Local Tolerance, Pharmacokinetics After Application of NCP112 Eye Drop in Healthy Subjects
The objective is to evaluate the safety, local tolerability, and pharmacokinetics of NCP112 eye drops through single and multiple dose-escalation ocular administrations in healthy adults.
- Conditions
- Xerophthalmia
- Being tested
- NCP112, NCP112 Placebo
- Medical subject headings
- Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCP112Drug
NCP112 topical ophthalmic solution
NCP112 PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending dose NCP112 Dose A | Experimental | NCP112 is administered once at a specified time in Day 1 Receives: Drug: NCP112 |
| Single Ascending dose NCP112 Dose A, Placebo | Placebo comparator | NCP112 Placebo is administered once at a specified time in Day 1 Receives: Drug: NCP112 Placebo |
| Single Ascending dose NCP112 Dose B | Experimental | NCP112 is administered once at a specified time in Day 1 Receives: Drug: NCP112 |
| Single Ascending dose NCP112 Dose B, Placebo | Placebo comparator | NCP112 Placebo is administered once at a specified time in Day 1 Receives: Drug: NCP112 Placebo |
| Single Ascending dose NCP112 Dose C | Experimental | NCP112 is administered once at a specified time in Day 1 Receives: Drug: NCP112 |
| Single Ascending dose NCP112 Dose C, Placebo | Placebo comparator | NCP112 Placebo is administered once at a specified time in Day 1 Receives: Drug: NCP112 Placebo |
| Multiple Ascending dose NCP112 Dose A | Experimental | NCP112 is administered twice daily. [time frame: Day 1- Day 14] Receives: Drug: NCP112 |
| Multiple Ascending dose NCP112 Dose A, Placebo | Placebo comparator | NCP112 Placebo is administered twice daily. [time frame: Day 1- Day 14] Receives: Drug: NCP112 Placebo |
| Multiple Ascending dose NCP112 Dose B | Experimental | NCP112 is administered twice daily.[time frame: Day 1- Day 14] Receives: Drug: NCP112 |
| Multiple Ascending dose NCP112 Dose B, Placebo | Placebo comparator | NCP112 Placebo is administered twice daily. [time frame: Day 1- Day 14] Receives: Drug: NCP112 Placebo |
| Multiple Ascending dose NCP112 Dose C | Experimental | NCP112 is administered twice daily.[time frame: Day 1- Day 14] Receives: Drug: NCP112 |
| Multiple Ascending dose NCP112 Dose C, Placebo | Placebo comparator | NCP112 Placebo is administered twice daily. [time frame: Day 1- Day 14] Receives: Drug: NCP112 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye irritation(Likert scale)
Local safety assessment
Measured: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Eye redness(Likert scale)
Local safety assessment
Measured: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Intraocular pressure
Opthalmic examination
Measured: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
History taking
Opthalmic examination
Measured: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Corrected vision test
Opthalmic examination
Measured: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Adverse events
Including subjective and objective symptoms
Measured: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Vital signs
Blood pressure
Measured: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Secondary outcomes (19)
Cmax
Single dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 4 (Blood sampling at specified times within the time frame)
AUClast
Single dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 4 (Blood sampling at specified times within the time frame)
Tmax
Single dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 4 (Blood sampling at specified times within the time frame)
AUCinf
Single dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 4 (Blood sampling at specified times within the time frame)
t1/2
Single dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 4 (Blood sampling at specified times within the time frame)
CL/F
Single dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 4 (Blood sampling at specified times within the time frame)
Vz/F
Single dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 4 (Blood sampling at specified times within the time frame)
Cmax
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
AUCtau
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Cmax,ss
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
AUCtau,ss
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Tmax
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Cmin,ss
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
t1/2,ss
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
CLss/F
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Vz,ss/F
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
PTF
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
R
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Tmax,ss
Multiple dose - Evaluation of pharmacokinetic profile
Measured: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start11 Jul 2024
- Primary completion28 Nov 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerophthalmiaStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- INJIN JANG, M.D.,Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263998
- Sponsor's protocol ID
- HUC1-394
- Status last verified
- Sep 2024
- First submitted
- 26 Jan 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Clinical Study to Assess the Safety, and Local Tolerance, Pharmacokinetics After Application of NCP112 Eye Drop in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06263998
- Acronym / sponsor ID
- HUC1-394
- Conditions
- Xerophthalmia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 28 Nov 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 16 Feb 2024 (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 objective is to evaluate the safety, local tolerability, and pharmacokinetics of NCP112 eye drops through single and multiple dose-escalation ocular administrations in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Single Ascending dose NCP112 Dose A | Experimental | Drug: NCP112NCP112 is administered once at a specified time in Day 1 |
| Single Ascending dose NCP112 Dose A, Placebo | Placebo comparator | Drug: NCP112 PlaceboNCP112 Placebo is administered once at a specified time in Day 1 |
| Single Ascending dose NCP112 Dose B | Experimental | Drug: NCP112NCP112 is administered once at a specified time in Day 1 |
| Single Ascending dose NCP112 Dose B, Placebo | Placebo comparator | Drug: NCP112 PlaceboNCP112 Placebo is administered once at a specified time in Day 1 |
| Single Ascending dose NCP112 Dose C | Experimental | Drug: NCP112NCP112 is administered once at a specified time in Day 1 |
| Single Ascending dose NCP112 Dose C, Placebo | Placebo comparator | Drug: NCP112 PlaceboNCP112 Placebo is administered once at a specified time in Day 1 |
| Multiple Ascending dose NCP112 Dose A | Experimental | Drug: NCP112NCP112 is administered twice daily. [time frame: Day 1- Day 14] |
| Multiple Ascending dose NCP112 Dose A, Placebo | Placebo comparator | Drug: NCP112 PlaceboNCP112 Placebo is administered twice daily. [time frame: Day 1- Day 14] |
| Multiple Ascending dose NCP112 Dose B | Experimental | Drug: NCP112NCP112 is administered twice daily.[time frame: Day 1- Day 14] |
| Multiple Ascending dose NCP112 Dose B, Placebo | Placebo comparator | Drug: NCP112 PlaceboNCP112 Placebo is administered twice daily. [time frame: Day 1- Day 14] |
| Multiple Ascending dose NCP112 Dose C | Experimental | Drug: NCP112NCP112 is administered twice daily.[time frame: Day 1- Day 14] |
| Multiple Ascending dose NCP112 Dose C, Placebo | Placebo comparator | Drug: NCP112 PlaceboNCP112 Placebo is administered twice daily. [time frame: Day 1- Day 14] |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult subjects aged 19 to 50 years at the time of screening (Visit 1).
- Subjects with a body weight of 50.0 kg or more, and a body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of screening (Visit 1).
- ※ Body Mass Index (BMI, kg/m²) = Weight (kg) / [Height (m)]²
- Subjects who have received sufficient explanation about the clinical trial, fully understand it, and have voluntarily decided to participate and signed the written informed consent.
- Subjects deemed suitable as participants for this clinical trial based on the investigators judgment after physical examination, clinical laboratory tests, and medical history obtained during screening (Visit 1).
Key exclusion criteria (32 listed)
- Subjects with clinically significant diseases or history of diseases related to the liver, kidneys, cardiovascular system, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system (such as epilepsy, mood disorders, obsessive-compulsive disorder), hematologic/oncologic system, or urinary system (chronic or recurrent urinary tract infections).
- Subjects with hepatitis B or C.
- Subjects meeting any of the following criteria based on ophthalmologic history or examination during screening (Visit 1):
- Subjects with a history of hypersensitivity to the active ingredients or excipients of the investigational drug, or to drugs in the same class as the active ingredients.
- Subjects who have taken any medications related to dry eye syndrome (e.g., artificial tears, anti-inflammatory agents like cyclosporine, hyaluronic acid preparations, tetracycline preparations) or drugs that could induce dry eye syndrome or affect the outcome of this clinical trial (e.g., oral contraceptives, antihistamines, sedatives, oral aspirin, corticosteroids) within one month prior to the anticipated first dose.
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 |
|---|---|---|
| NCP112NCP112 topical ophthalmic solution | Drug | Multiple Ascending dose NCP112 Dose A, Multiple Ascending dose NCP112 Dose B, Multiple Ascending dose NCP112 Dose C, Single Ascending dose NCP112 Dose A, Single Ascending dose NCP112 Dose B, Single Ascending dose NCP112 Dose C |
| NCP112 PlaceboPlacebo comparator | Drug | Multiple Ascending dose NCP112 Dose A, Placebo, Multiple Ascending dose NCP112 Dose B, Placebo, Multiple Ascending dose NCP112 Dose C, Placebo, Single Ascending dose NCP112 Dose A, Placebo, Single Ascending dose NCP112 Dose B, Placebo, Single Ascending dose NCP112 Dose C, Placebo |
Primary outcome
Eye irritation(Likert scale)
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Local safety assessment
Eye redness(Likert scale)
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Local safety assessment
Intraocular pressure
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Opthalmic examination
History taking
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Opthalmic examination
Corrected vision test
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Opthalmic examination
Adverse events
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Including subjective and objective symptoms
Vital signs
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Blood pressure
19 secondary outcomes
Cmax
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
AUClast
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
Tmax
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
AUCinf
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
t1/2
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
CL/F
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
Vz/F
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
Cmax
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
AUCtau
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Cmax,ss
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
AUCtau,ss
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Tmax
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Cmin,ss
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
t1/2,ss
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
CLss/F
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Vz,ss/F
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
PTF
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
R
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Tmax,ss
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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.
INJIN JANG, M.D.,Ph.D. principal investigator
Seoul National University Hospital
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 NCP112 in people with Xerophthalmia, run by Huons Co., Ltd. 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 5 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eunsoo Sim (+82-70-7492-5070, minie30@huons.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye irritation(Likert scale) (time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22). The study lists 7 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 1 Oct 2024.