Actively Recruiting
Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops
Led by Huons Co., Ltd. · Updated on 2024-10-01
60
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 19 to 50 years at screening
- Body weight of 50.0 kg or more
- Body mass index between 18.0 and 30.0 kg/m8
- Provided informed consent after understanding the trial
- Deemed suitable by investigator after physical exam, lab tests, and medical history
You will not qualify if you...
- Significant diseases or history affecting liver, kidneys, heart, gastrointestinal, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood/oncology, or urinary systems
- Hepatitis B or C infection
- Corrected visual acuity 20/40 or less
- Intraocular pressure above 21 mmHg
- History or suspicion of eye conditions like keratitis, iritis, uveitis, retinitis, dry eye syndrome, strabismus, glaucoma
- Contact lens use within one month before dosing or adverse effects from contact lenses
- Eye surgery or laser vision correction within 12 months
- Silicone punctal occlusion or cauterization within 3 months (collagen punctal occlusion within 1 month)
- Hypersensitivity to study drug or similar drugs
- Use of dry eye or related medications within one month before dosing
- Use of prescription drugs, health supplements, or over-the-counter drugs near dosing time unless approved
- Use of drug metabolism modifiers like barbiturates within one month
- History of drug abuse or positive drug test
- Inability to avoid grapefruit during study
- Abnormal blood pressure readings at screening
- History of alcohol abuse or regular heavy alcohol use within one month
- Regular caffeine use above specified limits or inability to abstain during study
- Regular smoking above 10 cigarettes/day within one month or inability to abstain during study
- Positive breath alcohol test at screening
- Participation in another clinical trial with investigational drug within 6 months
- Recent blood donation or transfusion within specified times
- Vaccination within 14 days before dosing or expected during study
- Positive pregnancy test, pregnancy, or breastfeeding unless surgically sterilized
- Inability or unwillingness to use double contraception or refrain from sperm donation during the study
- Other reasons deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Daehak-ro, Jongno-gu, South Korea, 03080
Actively Recruiting
Research Team
E
Eunsoo Sim
CONTACT
S
Soyoung Lee, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
12
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