This is a randomized, single-center, single-blind, placebo-controlled, dose-escalation Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of multiple intravenous (IV) infusions of KINE-101 in healthy adult volunteers.

The study includes three sequential cohorts with a total of 24 subjects (8 subjects per cohort; 6 assigned to KINE-101 and 2 to placebo). Subjects in the treatment groups receive KINE-101 once daily for 7 consecutive days at doses corresponding to their assigned cohort (Cohort 1: 120 mg, Cohort 2: 240 mg, Cohort 3: 360 mg). Subjects in the placebo group receive 0.9% saline under identical conditions. All subjects are admitted on Day -1, receive daily dosing from Day 1 through Day 7, and are discharged on Day 9 after completion of safety monitoring. Follow-up visits are conducted on Days 14, 21, 28, and 35. Dose escalation proceeds sequentially from the lowest-dose cohort (Cohort 1) to the highest-dose cohort (Cohort 3). Safety and tolerability data collected through Day 35 in each preceding cohort are reviewed before initiating dosing in the next higher-dose cohort.

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