Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTZ-951 Administered Once Daily for 15 Days in Anemic Subjects With End-stage Renal Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Vital signs and 12 lead ECGs
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit
- •Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit
- •Hemoglobin value as defined in the protocol
- •Meet the erythropoiesis-stimulating agent (ESA) therapy criteria at the Screening Visit as defined in the protocol
排除标准
- •Transferrin saturation and ferritin levels at the Screening Visit as defined in the protocol
- •Anemia due to known causes other than chronic kidney disease
- •Known history of hyporesponsiveness to ESAs
- •Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to Screening visit
研究组 & 干预措施
Dose 1 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
干预措施: JTZ-951 (Drug)
Dose 1 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
干预措施: Placebo (Drug)
Dose 2 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
干预措施: JTZ-951 (Drug)
Dose 2 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
干预措施: Placebo (Drug)
Dose 3 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
干预措施: JTZ-951 (Drug)
Dose 3 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
干预措施: Placebo (Drug)
Dose 4 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
干预措施: JTZ-951 (Drug)
Dose 4 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
干预措施: Placebo (Drug)
结局指标
主要结局
Vital signs and 12 lead ECGs
时间窗: 15 days
Hgb (hemoglobin)
时间窗: 15 days
TSAT (transferrin saturation)
时间窗: 15 days
Cmax (maximum concentration)
时间窗: 15 days
tmax (time to reach maximum concentration)
时间窗: 15 days
t1/2 (elimination half-life)
时间窗: 15 days
AUC (area under the concentration-time curve)
时间窗: 15 days
RBC (red blood cell) count
时间窗: 15 days
Number of subjects with adverse events
时间窗: 15 days
AR (accumulation ratio)
时间窗: 15 days
serum ferritin
时间窗: 15 days
次要结局
未报告次要终点