A Phase 1 MAD Study of KINE-101 in Healthy Volunteers

Inclusion Criteria: * Healthy male or female adults aged 19 to 55 years * Body weight ≥ 50.0 kg and Body Mass Index (BMI) between 18.5 and 30.0 kg/m² * Clinically healthy with no congenital or chronic diseases requiring treatment * Normal findings in physical examination, vital signs, 12-lead ECG, and clinical laboratory tests at screening * Provided written informed consent and willing to comply with all study restrictions and procedures Exclusion Criteria: * History or presence of clinically significant hepatic, renal, cardiovascular, respiratory, neurological, hematologic, endocrine, psychiatric, or malignant diseases * Abnormal ECG findings (QTc \> 450 ms for males or \> 470 ms for females; PR \> 200 ms; QRS \> 120 ms) * Abnormal liver or renal function (AST, ALT, ALP, γ-GT, or total bilirubin \> 2× ULN; eGFR \< 60 mL/min/1.73 m²) * Positive drug abuse test or history of substance abuse * Abnormal vital signs at screening (SBP ≤ 90 or ≥ 150 mmHg; DBP ≤ 60 or ≥ 100 mmHg; pulse ≤ 40 or ≥ 100 bpm) * Vaccination with live or attenuated vaccines or systemic corticosteroid use within 3 months before dosing * Use of enzyme-inducing/inhibiting drugs, herbal medicines, or other investigational products within 1-3 months before dosing * Donation or transfusion of blood within 3 months before dosing * Regular alcohol consumption \> 21 units/week, or inability to abstain during the study * Current smokers (\> 10 cigarettes/day) or inability to refrain from smoking during study participation * Intake of alcohol, grapefruit, quinine, Seville orange, or caffeine-containing products within 24-72 hours before dosing and during sampling periods * Engagement in strenuous exercise within 48 hours before dosing * Pregnant or breastfeeding women, or men and women not using reliable contraception * Recent COVID-19 or influenza infection or vaccination within 2 weeks before dosing * Difficult venous access or positive alcohol breath test * Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in the study