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

NCT06263998 | Recruiting Phase 1

• 1 other identifier: HUC1-394
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Xerophthalmia

Outcome Measures

Primary Outcomes (7)

• Eye irritation(Likert scale)

  Local safety assessment

  Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22

• Eye redness(Likert scale)

  Local safety assessment

  Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22

• Intraocular pressure

  Opthalmic examination

  Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22

• History taking

  Opthalmic examination

  Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22

• Corrected vision test

  Opthalmic examination

  Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22

• Adverse events

  Including subjective and objective symptoms

  Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22

• Vital signs

  Blood pressure

  Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22

Secondary Outcomes (19)

• Cmax

  Day 1~Day 4 (Blood sampling at specified times within the time frame)

• AUClast

  Day 1~Day 4 (Blood sampling at specified times within the time frame)

• Tmax

  Day 1~Day 4 (Blood sampling at specified times within the time frame)

• AUCinf

  Day 1~Day 4 (Blood sampling at specified times within the time frame)

• t1/2

  Day 1~Day 4 (Blood sampling at specified times within the time frame)

Study Arms (12)

Single Ascending dose NCP112 Dose A

EXPERIMENTAL

NCP112 is administered once at a specified time in Day 1

Drug: NCP112

Single Ascending dose NCP112 Dose A, Placebo

PLACEBO COMPARATOR

NCP112 Placebo is administered once at a specified time in Day 1

Drug: NCP112 Placebo

Single Ascending dose NCP112 Dose B

EXPERIMENTAL

NCP112 is administered once at a specified time in Day 1

Drug: NCP112

Single Ascending dose NCP112 Dose B, Placebo

PLACEBO COMPARATOR

NCP112 Placebo is administered once at a specified time in Day 1

Drug: NCP112 Placebo

Single Ascending dose NCP112 Dose C

EXPERIMENTAL

NCP112 is administered once at a specified time in Day 1

Drug: NCP112

Single Ascending dose NCP112 Dose C, Placebo

PLACEBO COMPARATOR

NCP112 Placebo is administered once at a specified time in Day 1

Drug: NCP112 Placebo

Multiple Ascending dose NCP112 Dose A

EXPERIMENTAL

NCP112 is administered twice daily. \[time frame: Day 1- Day 14\]

Drug: NCP112

Multiple Ascending dose NCP112 Dose A, Placebo

PLACEBO COMPARATOR

NCP112 Placebo is administered twice daily. \[time frame: Day 1- Day 14\]

Drug: NCP112 Placebo

Multiple Ascending dose NCP112 Dose B

EXPERIMENTAL

NCP112 is administered twice daily.\[time frame: Day 1- Day 14\]

Drug: NCP112

Multiple Ascending dose NCP112 Dose B, Placebo

PLACEBO COMPARATOR

NCP112 Placebo is administered twice daily. \[time frame: Day 1- Day 14\]

Drug: NCP112 Placebo

Multiple Ascending dose NCP112 Dose C

EXPERIMENTAL

NCP112 is administered twice daily.\[time frame: Day 1- Day 14\]

Drug: NCP112

Multiple Ascending dose NCP112 Dose C, Placebo

PLACEBO COMPARATOR

NCP112 Placebo is administered twice daily. \[time frame: Day 1- Day 14\]

Drug: NCP112 Placebo

Interventions

NCP112 DRUG

NCP112 topical ophthalmic solution

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 Placebo DRUG

Placebo comparator

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

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Daehak-ro, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Xerophthalmia

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases

Study Officials

• INJIN JANG, M.D.,Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunsoo Sim

CONTACT

+82-70-7492-5070; minie30@huons.com

Soyoung Lee, MS

CONTACT

+82-70-7492-5736; soyoung.lee@huons.com

Study Design

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

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 16, 2024
• Study Start: July 11, 2024
• Primary Completion: November 28, 2025
• Study Completion: January 30, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

KR (1)