A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, and Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics; Including an Open-label Cohort to Determine the Effect of Food on the Pharmacokinetics of D-0120-NA Tablet in Healthy Volunteers in the United States
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs).
In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label manner; once in the fasted state and once in the fed state.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be medically documented as healthy and acceptable at physical examination.
- •Subjects serum uric acid level at screening ≥ 4.5 mg/dL.
- •Subjects must have a BMI between 18.0 and 30.0 kg/m2 and a body weight of 50 kg or higher
- •Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator.
- •Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator.
- •Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.
排除标准
- •Any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
- •Any history or suspicion of kidney stones.
- •Positive for HIV, Hepatitis B, and/or Hepatitis C.
- •Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing.
- •Undergone major surgery within 3 months prior to Day
- •Women who are pregnant or breastfeeding.
- •Subjects who received any investigational test article within 5 half-lives or 30 days prior to Day 1 study medication dosing.
- •Subjects who consumed Seville oranges- or grapefruit-containing foods or beverages within 7 days before Day 1 and during the entire study duration.
- •Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
研究组 & 干预措施
D-0120 Dose 1
D-0120 Dose 1 Patients will get D-0120 single agent or placebo of matching size during dose escalation
干预措施: D-0120 (Drug)
D-0120 Dose 2
D-0120 Dose 2 Patients will get D-0120 single agent or placebo of matching size during dose escalation
干预措施: D-0120 (Drug)
D-0120 Dose 3
D-0120 Dose 3 Patients will get D-0120 single agent or placebo of matching size during dose escalation
干预措施: D-0120 (Drug)
D-0120 Dose 4
D-0120 Dose 4 Patients will get D-0120 single agent or placebo of matching size during dose escalation
干预措施: D-0120 (Drug)
D-0120 Dose 5
D-0120 Dose 5 Patients will get D-0120 single agent once in the fasted state and once in the fed state.
干预措施: D-0120 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 2 weeks
Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs
次要结局
- Pharmacokinetic: Apparent terminal half-life (t1/2)(Day-1 through 3)
- Pharmacokinetic: area under the plasma concentration versus time curve (AUC)(Day-1 through 3)
- Pharmacokinetic: maximum plasma drug concentration (Cmax)(Day-1 through 3)
- Pharmacokinetic: Time to reach the Cmax (Tmax)(Day-1 through 3)
- Pharmacokinetic: Apparent oral clearance (CL/F)(Day-1 through 3)
- PD profile of D-0120 from plasma and urine(Day-1 through 3)
- Pharmacokinetic: Apparent volume of distribution (Vz/F)(Day-1 through 3)