A Randomized, Double-blind, Single Ascending Oral Dose Study To Evaluate Safety, Tolerability And Pharmacokinetics Of PCO371 In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Safety as assessed by pulse rate
研究概览
简要总结
This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in healthy adult males.
Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 18 to 45 years.
- •Caucasian(BMI 18-30 mg/kg2) or first generation japanese(BMI 18-25kg/m2)
- •Able and willing to abide by the protocol
排除标准
- •Evidence of any medical condition that could affect renal, hepatic, or cardiopulmonary functions.
研究组 & 干预措施
PCO371
Single oral dose of PCO371
干预措施: PCO371 (Drug)
Placebo Comparator
Single oral dose of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety as assessed by pulse rate
时间窗: 15days or 22days
Safety as assessed by adverse events
时间窗: 15days or 22days
Safety as assessed by temperature
时间窗: 15days or 22days
Safety as assessed by systolic blood pressure, diastolic blood pressure
时间窗: 15days or 22days
Safety assessed by physical findings examinations, including weight
时间窗: 15days or 22days
Safety as assessed by Laboratory test values
时间窗: 15days or 22days
Laboratory tests include hematology, biochemistry, urine analysis and coagulation
Safety as assessed by ECGs
时间窗: 15days or 22days
Plasma concentrations and PK parameters (AUC, Cmax, Tmax, total clearance, volume of distribution and T1/2) of PCO371 in healthy male volunteers
时间窗: 15days or 22days
Urine concentrations and PK parameters (cumulative excretion and renal clearance) of PCO371
时间窗: 15days or 22days
次要结局
- The Urinary excretion of Ca, phosphate, magnesium, protein, sodium, potassium, chloride, and cAMP of PCO371(15days)
- The Nephrogenous cAMP of PCO371(15days)
- The Time profile of serum/plasma concentrations in albumin-corrected total calcium (Ca); 25-hydroxy vitamin D (vit D), 1,25-dihydroxy vit D, and 24,25-dihydroxy vit D; phosphate; magnesium; and cAMP of PCO371(15days)