A Randomized, Single-center, Single-blind, Placebo-controlled, Dose Escalation Phase 1 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Characteristics of Multiple Intravenous Infusions of KINE-101 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
KINE-101
干预措施: KINE-101 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: From Day 1 to Day 35 (End of Study visit)
Number and percentage of subjects experiencing any treatment-emergent adverse event (TEAE) following multiple intravenous administrations of KINE-101 or placebo. Safety assessments will also include concomitant medications, physical examinations, local injection site reactions, and vital signs.
次要结局
- Maximum plasma concentration (Cmax)(From Day 1 (pre-dose) through Day 7 post-dose)
- Area under the plasma concentration-time curve (AUC)(From Day 1 (pre-dose) through Day 7 post-dose)
- Terminal half life (t½)(From Day 1 (pre-dose) through Day 7 post-dose)