Trials Sponsors Conditions Drugs Pricing

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)
+14 more secondary outcomes

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

Interventions

NCP112Drug

NCP112 topical ophthalmic solution

Multiple Ascending dose NCP112 Dose AMultiple Ascending dose NCP112 Dose BMultiple Ascending dose NCP112 Dose CSingle Ascending dose NCP112 Dose ASingle Ascending dose NCP112 Dose BSingle Ascending dose NCP112 Dose C

NCP112 PlaceboDrug

Eligibility Criteria

Age19 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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).

Sponsors & Collaborators

Huons Co., Ltd.
Industrylead

Study Sites (1)

Seoul National University Hospital

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

RECRUITING

INJIN JANG, MD, PH.DCONTACT

MeSH Terms

Conditions

Xerophthalmia

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesDry Eye SyndromesLacrimal 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

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

Actual (reported)

Primary Completion

November 28, 2025

Estimated (date passed)

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
+17 more criteria

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (19)

Study Arms (12)

Single Ascending dose NCP112 Dose A

Single Ascending dose NCP112 Dose A, Placebo

Single Ascending dose NCP112 Dose B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Single Ascending dose NCP112 Dose B, Placebo

Single Ascending dose NCP112 Dose C

Single Ascending dose NCP112 Dose C, Placebo

Multiple Ascending dose NCP112 Dose A

Multiple Ascending dose NCP112 Dose A, Placebo

Multiple Ascending dose NCP112 Dose B

Multiple Ascending dose NCP112 Dose B, Placebo

Multiple Ascending dose NCP112 Dose C

Multiple Ascending dose NCP112 Dose C, Placebo

You may not qualify if:

Source record

Locations