Study on Tolerability, Pharmacokinetics and Pharmacodynamics of SHR6508 in Chinese Patients With Secondary Hyperparathyroidism of Chronic Kidney Disease Treated by Maintenance Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Tmax, Time of maximum observed concentration.
研究概览
简要总结
The study is being conducted to evaluate the tolerability, pharmacokinetics and pharmacodynamics of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Diagnosed with end stage renal disease receiving stable hemodialysis
- •Male or female
- •Meet the Body Mass Index standard
- •Conform to the ASA Physical Status Classification
- •Stably use of concomitant medication of other therapies of SHPT
- •Meet the standard of iPTH level, cCa and HB
排除标准
- •Subjects with a history of malignant tumor
- •Subjects with neuropsychiatric diseases
- •Subjects with a history of cardiovascular diseases
- •Subjects with gastrointestinal diseases
- •Subjects with a history of surgery
- •Subjects with a history of blood loss
- •Subjects with a history of parathyroidectomy or planned during the study
- •Subjects with a history of kidney transplant or planned during the study
- •Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin, platelet counts.
- •Subjects with a treatment history of similar drugs
- •Allergic to a drug ingredient or component
- •Pregnant or nursing women
- •No birth control during the specified period of time
- •Subject with a history of alcohol abuse and drug abuse
- •Participated in clinical trials of other drugs (received experimental drugs)
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
group A
Experimental: SHR6508 Placebo Comparator: normal saline
干预措施: SHR6508；Placebo (Drug)
group B
Experimental: SHR6508 Placebo Comparator: normal saline
干预措施: SHR6508；Placebo (Drug)
group C
Experimental: SHR6508 Placebo Comparator: normal saline
干预措施: SHR6508；Placebo (Drug)
group D
Experimental: SHR6508 Placebo Comparator: normal saline
干预措施: SHR6508；Placebo (Drug)
结局指标
主要结局
Tmax, Time of maximum observed concentration.
时间窗: 0 hour to 43 hours after first dose administration
Cmax, Maximum observed concentration.
时间窗: 0 hour to 43 hours after first dose administration
AUC0-t,ss, Area under the concentration-time curve from time zero to the last measurable concentration at steady-state.
时间窗: Day1-Day29(if reach steady-state)
AUC0-t, Area under the concentration-time curve from time zero to the last measurable concentration.
时间窗: 0 hour to 43 hours after first dose administration
AUC0-∞, Area under the curve from time 0 extrapolated to infinite time
时间窗: 0 hour to 43 hours after first dose administration
CLz, Total Body Clearance
时间窗: 0 hour to 43 hours after first dose administration
MRT0-t, Mean residence time from time zero to the last measurable concentration.
时间窗: 0 hour to 43 hours after first dose administration
AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state.
时间窗: Day1-Day29(if reach steady-state)
Vss, Volume of distribution based on the terminal phase at steady-state.
时间窗: Day1-Day29(if reach steady-state)
DF: Degree of Fluctuation
时间窗: Day1-Day29(if reach steady-state)
t1/2z, Terminal elimination half-life
时间窗: 0 hour to 43 hours after first dose administration
Vz, Volume of distribution based on the terminal phase
时间窗: 0 hour to 43 hours after first dose administration
Cmax,ss : Maximum observed concentration at steady-state.
时间窗: Day1-Day29(if reach steady-state)
Cav : Average concentration
时间窗: Day1-Day29(if reach steady-state)
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time.
时间窗: Day1-Day29(if reach steady-state)
Cmin,ss : Minimum observed concentration at steady-state
时间窗: Day1-Day29(if reach steady-state)
Tmax,ss, Time of maximum observed concentration at steady-state.
时间窗: Day1-Day29(if reach steady-state)
t1/2z,ss, Terminal elimination half-life at steady-state
时间窗: Day1-Day29(if reach steady-state)
CLss, Total Body Clearance at steady-state.
时间窗: Day1-Day29(if reach steady-state)
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time
时间窗: 0 hour to 43 hours after first dose administration
Accumulation Ratio
时间窗: Day1-Day29(if reach steady-state)
次要结局
- Change From Baseline to End of Study in serum iPTH, cCa, P, FGF23 and BSAP(Day1 to Day29)
- Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline(Day1 to Day29)
- Participants With Treatment-Emergent Adverse Events (TEAEs)(Day1 to End of Study, End of Study is about Day55)
- Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP(0 hour to 43 hours after first dose administration)
- Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline(Day1 to Day29)