An Open Label, Four Week, Dose Escalating Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Study of CTA018 Injection in Subjects With Stage 5 Chronic Kidney Disease With Secondary Hyperparathyroidism on Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 12
- 主要终点
- To investigate the safety of CTA018 Injection
研究概览
简要总结
This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. This study will also investigate the safety and effects of different strengths of CTA018, on parathyroid hormone (PTH) levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index between 18 and 35
- •On maintenance hemodialysis three times per week
- •Serum iPTH value greater than or equal to 300 pg/mL and lower than or equal to 1000 pg/mL
- •Adjusted or total serum calcium value greater than or equal to 8.4 mg/dL and lower than 10.0 mg/dL
- •Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
- •Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL
- •Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and the length of study
排除标准
- •On bisphosphonates for at least three months prior to first dose of Study Drug
- •Currently taking cytochrome P450 3A inhibitors and/or inducers
- •Abnormal liver functions
研究组 & 干预措施
CTA018 Injection low dose
Low dose IV 3 times a week for 4 weeks
干预措施: CTA018 Injection (Drug)
CTA018 Injection low to mid dose
low to mid dose IV 3 times a week for 4 weeks
干预措施: CTA018 Injection (Drug)
CTA018 Injection mid to high dose
mid to high dose IV 3 times a week for 4 weeks
干预措施: CTA018 Injection (Drug)
CTA018 Injection high dose
high dose IV 3 times a week for 4 weeks
干预措施: CTA018 Injection (Drug)
结局指标
主要结局
To investigate the safety of CTA018 Injection
时间窗: Throughout the study
To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection
时间窗: Day 1 and 12 of each dose level
次要结局
- To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection(Throughout the study)
- To determine the efficacy of CTA018 Injection to reduce serum iPTH(Throughout the study)