Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops

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

Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops (NCT06263998) is a Phase 1 interventional studying Xerophthalmia, sponsored by Huons Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Xerophthalmia, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Xerophthalmia subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Healthy adult subjects aged 19 to 50 years at the time of screening (Visit 1). 2. 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 3. Subjects who have received sufficient explanation about the clinical trial, fully understand it, and have voluntarily decided to participate and signed the written willing to sign a consent form. 4. 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 Should NOT Join This Trial: 1. 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). 2. Subjects with hepatitis B or C. 3. 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. - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Healthy adult subjects aged 19 to 50 years at the time of screening (Visit 1). 2. 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 3. 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. 4. 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). Exclusion Criteria: 1. 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). 2. Subjects with hepatitis B or C. 3. 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. * 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. 4. 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. 5. 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. 6. 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). 7. Subjects who have taken drug metabolism inducers or inhibitors, such as barbiturates, within one month prior to the expected first dosing date 8. Subjects with a history of drug abuse or a positive result on a urine drug test at screening (Visit 1). 9. 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. 10. 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). 11. 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. 12. 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. 13. 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. 14. Subjects who test positive on a breath alcohol test at screening (Visit 1). 15. Subjects who have participated in another clinical trial and received an investigational drug within 6 months prior to the anticipated first dose. 16. 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. 17. 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. 18. 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). 19. 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). 20. Subjects deemed unsuitable for participation by the investigator for other reasons (e.g., non-compliance with instructions).

Treatments Being Tested

DRUG

NCP112

NCP112 topical ophthalmic solution

DRUG

NCP112 Placebo

Placebo comparator

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Seoul National University Hospital

Seoul, Daehak-ro, Jongno-gu, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06263998), the sponsor (Huons Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06263998 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06263998?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06263998?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06263998. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06263998. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.