NCT04097405已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, and Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of D-0120 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The number of subjects with treatment related adverse events as assessed
研究概览
简要总结
This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double Blind, placebo controlled
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 at physical examination
- •Moderate smokers or non-smokers
- •Subjects must be between the ages of 18 and 60
- •Subject must have a BMI between 18.0 and 30.0 kg/m2 (inclusive)
- •Subjects must have a body weight of 50kg or higher for males and 45kg or higher for females
- •Females must be non-pregnant and non-lactating, and either surgically sterile at least 6 months prior to the first study drug administration or post-menopausal for 12 months or greater
- •Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner must be willing to use an acceptable contraceptive method throughout the study and for 90 days after the last study drug administration
- •Male subjects with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study administration
- •Subjects must have a complete blood count and platelet count within the normal range
- •Subjects must have a normal urinalysis
- •Subjects must have a normal estimated glomerular filtration rate
- •Subjects must have a normal ECG
- •Subjects must be able to understand the study procedures, risks involved and be able to comply with the study and follow-up procedures
- •Male subjects must be willing not to donate sperm until 90 days following the last study drug administration
排除标准
- •Subjects with any history or clinical manifestations of disorders
- •Subjects who have any history or suspicion of kidney stones
- •Subjects who are HIV, Hep B or Hep C positive
- •History of significant allergic reactions to any drug
- •Clinically significant ECG abnormalities
- •History of significant drug abuse within 1 year prior to screening or use of soft drugs within 3 months prior to screening or hard drugs within 1 year prior to screening
- •Subjects who have used prescription dugs, over the counter drugs or herbal remedies within 14 days before day 1
- •Positive urine drug screen, alcohol breath at screening
- •Subjects had undergone major surgery within 3 months
- •Women who are pregnant or breastfeeding
- •History of significant alcohol abuse
- •Subjects who consumed Seville oranges-or grapefruit-containing food or beverages within 7 days before Day 1 and during the entire study duration.
- •Subjects with any condition that, in the judgement of the investigator, would place him/her at undue risk
- •Participation in a clinical research study involving the administration of an investigation or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to first dose
- •Donation of plasma within 7 days prior to dosing
研究组 & 干预措施
D-0120 Dose Ascending Cohorts 1-4
Active Comparator
D-0120 dose daily for up to 7 days.
干预措施: D-0120 (Drug)
Placebo Dose Ascending Cohorts 1-4
Placebo Comparator
Placebo dose daily for up to 7 days
干预措施: Placebo oral tablet (Drug)
D-0120/Uric Acid Lowering Agent Cohort 6
Experimental
D-0120 in combination with a uric acid lowering agent for up to 7 days of combination therapy
干预措施: D-0120 (Drug)
结局指标
主要结局
The number of subjects with treatment related adverse events as assessed
时间窗: Reporting of adverse events starts at enrollment through the end of the follow up period (14 days (cohorts 1-4) and 16 days (cohort 6)
Data will include clinical observations, ECG, clinical chemistry/hematology/urinalysis and vital signs
次要结局
- Maximum Observed Plasma Concentration (Cmax) of D-0120(Day 1-Day 7)
- Time to observed Cmax (Tmax)for D-0120(Timeframe: Day 1-Day7)
- Area under the plasma concentration-time curve (AUC) for D-0120(Day 1-Day 7)
研究者
研究点 (1)
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