Clinical trial NCT06263998: Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Xerophthalmia
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Eye irritation(Likert scale)
timeFrame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
measure: Eye redness(Likert scale)
timeFrame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
measure: Intraocular pressure
timeFrame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
measure: History taking
timeFrame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
measure: Corrected vision test
timeFrame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
measure: Adverse events
timeFrame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
measure: Vital signs
timeFrame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Secondary outcomes:
measure: Cmax
timeFrame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
measure: AUClast
timeFrame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
measure: Tmax
timeFrame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
measure: AUCinf
timeFrame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
measure: t1/2
timeFrame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
measure: CL/F
timeFrame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
measure: Vz/F
timeFrame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
measure: Cmax
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
measure: AUCtau
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
measure: Cmax,ss
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
measure: AUCtau,ss
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
measure: Tmax
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
measure: Cmin,ss
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
measure: t1/2,ss
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
measure: CLss/F
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
measure: Vz,ss/F
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
measure: PTF
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
measure: R
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
measure: Tmax,ss
timeFrame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Daehak-ro, Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: INJIN JANG, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: