A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To evaluate the safety profile of AR882 based on incidence of adverse events
研究概览
简要总结
A study to assess multiple ascending doses of AR882 in healthy adult males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Screening serum uric acid level ≥ 4.5 mg/dL (268 µmol/L) and < 9 mg/dL (535 µmol/L)
- •Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
- •Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures
排除标准
- •Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- •History of cardiac abnormalities
- •History and/or presence of drug addiction or excessive use of alcohol
结局指标
主要结局
To evaluate the safety profile of AR882 based on incidence of adverse events
时间窗: 22 Days
Incidence of adverse events following multiple doses of AR882
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
时间窗: 22 Days
Incidence of abnormal laboratory findings following multiple doses of AR882
To evaluate the safety profile of AR882 based on incidence of abnormal electrocardiogram findings
时间窗: 22 Days
Incidence of abnormal electrocardiogram findings following multiple doses of AR882
To evaluate the safety profile of AR882 based on incidence of abnormal vital signs findings
时间窗: 22 Days
Incidence of abnormal vital signs findings following multiple doses of AR882
Time to maximum plasma concentration (Tmax) for AR882
时间窗: 15 Days
Profile from plasma in terms of Tmax following multiple doses of AR882
Area under the curve (AUC) for plasma AR882
时间窗: 15 Days
Profile from plasma in terms of AUC following multiple doses of AR882
Maximum plasma concentration (Cmax) for AR882
时间窗: 15 Days
Profile from plasma in terms of Cmax following multiple doses of AR882
Apparent terminal half-life (t1/2) for AR882
时间窗: 15 Days
Profile from plasma in terms of t1/2 following multiple doses of AR882
Fractional Excretion (FEUA) for AR882
时间窗: 15 Days
Profile from urine in terms of FEUA following multiple doses of AR882
Amount excreted (Ae) into urine for AR882
时间窗: 15 Days
Profile from urine in terms of Ae following multiple doses of AR882
次要结局
- PD profile following multiple doses of AR882(15 Days)