None listed
Conditions
Interventions
Drug : This study will be conducted as a randomized, double-blind, placebo-controlled, SAD/MAD (Single Ascending Dose/Multiple Ascending Dose) trial. The study will proceed sequentially, starting from
Sponsors
RudaCure
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy adult male volunteers aged 19 to 50 years at the time of screening. 2) Individuals with a body weight between 50.0 kg and 90.0 kg and a Body Mass Index (BMI) between 18.5 kg/m² and 29.9 kg/m² at the time of screening. BMI(kg/m2)=Weight(kg)/Height(m)2BMI (kg/m²) = Weight (kg) / {Height (m)}²BMI(kg/m2)=Weight(kg)/Height(m)2 3) Individuals who have received a full explanation of this clinical trial, fully understand it, voluntarily decided to participate, and provided written consent to comply with study guidelines. 4) Individuals deemed suitable as study participants by the investigator based on physical examination, clinical laboratory tests, medical history, and other assessments.
Exclusion criteria
Exclusion criteria: 1) Individuals with current or past clinically significant disorders involving the hepatobiliary system (such as severe liver dysfunction or viral hepatitis), kidneys (such as severe kidney dysfunction), nervous system, immune system, respiratory system, gastrointestinal system, endocrine system, hematology/oncology, cardiovascular system (such as heart failure or Torsades de Pointes), urinary system, or psychiatric conditions (such as mood disorders or obsessive-compulsive disorder). Also includes individuals with the following past medical history: Systemic immunosuppressant therapy (within 3 years of the screening date) Organ or bone marrow transplantation (at any time in their lifetime) Malignancy (at any time in their lifetime) 2) Individuals who meet any of the following criteria (disease or medical history) based on medical history and ophthalmologic examination: Best corrected visual acuity of 20/40 (Snellen chart 0.5) or worse at the time of screening Current or past history or signs of visual organ disorders, such as ocular hypertension, glaucoma, allergy, active eye infections (e.g., uveitis, iritis, blepharitis), autoimmune diseases (e.g., Sjogren's syndrome), retinal disorders, corneal surface disorders, abnormal corneal sensitivity, or excessive tearing Have undergone ophthalmologic surgery (e.g., intraocular surgery or LASIK) within 12 months prior to the first dose of the investigational product Have undergone silicone punctal occlusion or punctal cauterization within 3 months prior to the first dose of the investigational product Unable to discontinue dry eye–related products (e.g., artificial tears, anti-inflammatory agents such as cyclosporine, hyaluronic acid preparations, tetracycline preparations) or medications that may induce dry eyes or impact efficacy and safety evaluation (e.g., oral contraceptives, anticholinergic drugs, tricyclic antidepressants, antihistamines, sleeping pills, diuretics, antimuscarinic agents, beta-blockers, oral aspirin, corticosteroids, mast cell stabilizers) within 4 weeks or five times the drug’s half-life, whichever is longer, before the first dose of the investigational product Experienced side effects from contact lenses or have worn contact lenses within 4 weeks prior to the first dose of the investigational product and are unable to refrain from wearing contact lenses during the study period Intraocular pressure measured at screening exceeding 21 mmHg in either eye or below 10 mmHg Shows clinically significant abnormal findings on ophthalmic examination at screening that deem them unsuitable for the clinical trial 3) Individuals with known hypersensitivity to investigational products, related compounds, or any other drugs (such as aspirin or antibiotics) or a history of clinically significant hypersensitivity reactions 4) Individuals testing positive in serological tests (e.g., hepatitis B, hepatitis C, HIV, syphilis) 5) Individuals with a history of substance abuse or a positive result on urine drug screening for abusive drugs 6) Individuals showing the following vital signs after 3 minutes of rest in a seated position during screening: Systolic blood pressure 450 msec on ECG or clinically significant abnormal rhythm findings at screening 8) Individuals showing any of the following results in clinical laboratory tests, including additional screening exa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Pharmacokinetic Characteristics: Plasma Concentration of RCI001;Safety Evaluation: Adverse Events;Safety Evaluation: Vital Signs (systolic/diastolic blood pressure, pulse, body temperature);Safety Evaluation: Physical Examination;Safety Evaluation: Electrocardiogram (12-lead ECG);Safety Evaluation: Clinical Laboratory Tests (hematology, blood chemistry, urinalysis);Safety Evaluation: Ophthalmic Symptom Assessment (blurred vision, photophobia or light sensitivity, foreign body sensation in the eye, eye irritation, eye pain, eye itching, dry eye, eye redness, unintended tearing);Safety Evaluation: Comprehensive Ophthalmologic Examination (Best Corrected Visual Acuity Test, Slit Lamp Biomicroscopy, Fundoscopy, Intraocular Pressure Test, Visual Field Test, Corneal Refraction Test, Fundus Photography, Optical Coherence Tomography);Safety Evaluation: Abbreviated Ophthalmic Examination (Best Corrected Visual Acuity Test, Slit Lamp Biomicroscopy, Fundoscopy, Intraocular Pressure Test) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoonjin Kim
Seoul National University Hospital
Outcome results
None listed