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

Xerophthalmia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06263998
• Other study ID #: HUC1-394
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 3, 2024
• Est. completion date: January 30, 2026

Study information

• Verified date: January 2024
• Source: Huons Co., Ltd.
• Contact: SUNGGUK CHO
• Phone: +82-02-854-4700
• Email: sgcho[@]huons.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 30, 2026
• Est. primary completion date: November 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Healthy adult volunteers aged 19 to 50 at the time of the screening test

2. Those who weigh more than 50.0 kg at the time of the screening test and have a body mass index (BMI) of greater than or equal to 18.0 kg/m2 and less than 30.0 kg/m2 ? Body mass index (kg/m2) = Weight (kg)/[Height (m)]2

3. A person who, after hearing and fully understanding this clinical trial, has voluntarily decided to participate and agreed in writing to comply with the precautions

4. A person suitable as a test subject for the clinical trial judged by the tester through the results of the examination conducted in the screening, such as physical examination, clinical laboratory examination, interview, etc

Exclusion Criteria:

1. Those with a history of clinically significant liver, kidney, cardiovascular system, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system (interstitial, mood disorders, obsessive compulsive disorders), blood and tumor system, and urinary system (chronic or recurrent urinary tract infection)

2. a person with hepatitis B or C

3. A person who falls under any of the following items on an ophthalmic questionnaire or examination conducted during screening

• Those with calibration vision of 20/40 (agar stone vision table 0.5) or less
• Those who exceed 21 mmHg in either eye pressure test
• Those who have a history of tear discharge organ disease or whose tear discharge rate is not normal
• A person who has a history of visual organ diseases, including keratitis, irisitis, uveitis, retinitis, dry eye, strabismus, glaucoma, etc., or has suspected symptoms or symptoms
• Those who have experienced side effects after wearing contact lenses, or who have worn contact lenses within one month from the expected first dose, or who are unable to comply with the ban on wearing contact lenses during the clinical trial period
• Those who have undergone ophthalmic surgery and laser vision correction surgery (LASIK, etc.) within 12 months from the expected first dose
• Those who have undergone silicone tear point closure/tear point cauterization within 3 months from the expected first dose (but those who have undergone collagen tear point closure within 1 month)
• Any other person who shows abnormal findings in an ophthalmic examination

4. A person who has a history of hypersensitivity to drugs of the same series as the main components and components of clinical trial drugs

5. Those who have taken eye dryness-related drugs (artificial tears, anti-inflammatory drugs such as cyclosporine, hyaluronic acid, tetracycline, etc.) within one month of the expected first dose, or drugs that can cause eye dryness or affect the results of this clinical trial (e.g., oral contraceptives, antihistamines, sleeping pills, oral aspirin, corticosteroid, etc.)

6. A person who has administered any prescription drugs, eye drops, herbal medicines, etc. other than eye drops or eye drops related to dry eyes within two weeks from the expected first dose, or who has taken health functional foods or vitamins including any over-the-counter drugs or liver functional supplements within one week (However, if other conditions are reasonable at the discretion of the tester, he/she may participate in the clinical trial.)

7. A person who has taken drug metabolite-inducing and inhibiting drugs such as barbiturant drugs within one month prior to the expected first dose date

8. A person who has a history of drug abuse or who tested positive for a urine drug test at the time of a screening test

9. A person who cannot restrict the intake of grapefruit or food containing it during the clinical trial period from 7 days before the expected first dose date

10. Those with systolic blood pressure of 90 mmHg or more, 140 mmHg or more, diastolic blood pressure of 50 mmHg or more, or 90 mmHg or more when measured after maintaining a position for at least 3 minutes without any sudden change in body position at the time of screening

11. Those who have a history of alcohol abuse, drink continuously (21 units/week excess, 1 unit = 10 g = 12.5 mL of pure alcohol) within one month from the expected first dose, or who cannot abstain from drinking during the clinical trial period

12. A person who continuously consumes caffeine (coffee or green tea>5 units/day) or who is unable to consume caffeine-containing food during clinical trials from 24 hours before hospitalization

13. A person who continuously smokes (including e-cigarettes, more than 10 cigarettes/day) within one month from the expected first dose, or who cannot quit during the clinical trial period

14. A person who tested positive for alcohol breath at the time of the screening test

15. A person who participated in other clinical trials and received clinical trials within six months from the expected first dose

16. A person who has donated whole blood or donated ingredients within two months before the expected first dose, or who has received a blood transfusion within one month before the expected first dose, or who plans to donate blood or transfuse during the clinical trial period

17. A person who has received a vaccine within 14 days prior to the expected first dose or is expected to be administered during the trial period

18. For all women except those who have undergone surgical infertility (Bilateral ligation, Bilatal Oupectomy, or Hystectomy), the results of a pregnancy test (urine hCG) conducted prior to the commencement of clinical drug administration are positive, pregnant or nursing women

19. Those who do not agree to donate sperm during the pre-clinical trial period and up to at least 90 days after the last clinical trial drug administration, or their spouse or partner's medically recognized use of appropriate double contraception or medically acceptable contraception, and who do not agree to donate sperm until that period ? a medically acceptable method of contraception

• Use of intrauterine devices with proven pregnancy failure rates in spouses (or partners)
• Double contraception (Blocking contraception is used in both men and women)
• Surgery by yourself or your partner (vascular resection, ovascular resection/ligation, hysterectomy)

20. A person who determines that the tester is unfit to participate in the clinical trial due to other reasons (refusal, etc.)

Related Conditions & MeSH terms

• Xerophthalmia

Intervention

Drug:
• NCP112
NCP112 topical ophthalmic solution
• NCP112 Placebo
Placebo for NCP112 topical ophthalmic solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huons Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-Emergent Adverse Events	- local safety assessment(local eye irritation and ocular redness assessment / Likert Scale); local eye irritation(Likert scale) 0 - None of the time; 1- Some of the time 2 - Half of the time 3 - Most of the time 4 - All of the time; ocular redness assessment(Likert Scale); - None; - Mild; - Moderate; - Severe	Day 2, Day 3, Day 4
Secondary	Evaluation of pharmacokinetic profile	Tmax(Time to peak drug concentration)	Day 2, Day 3, Day 4
Secondary	Evaluation of pharmacokinetic profile	Cmax(Peak Plasma Concentration)	Day 2, Day 3, Day 4