An open label, randomized, three dose, parallel, safety, pharmacokinetic, pharmacodynamic and immunogenicity assessment study of Navalbumin(Recombinant Human albumin) with Human Albumin in healthy adult humansubjects.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- • To determine the maximum tolerated dose (MTD)
研究概览
简要总结
This is a phase-I open label, randomized, three dose, parallel, safety, pharmacokinetic, pharmacodynamic and immunogenicity assessment study of Navalbumin (Recombinant Human albumin) with Human Albumin in healthy adult human subjects.
Objectives:
Part 1:
• To establish safety and tolerability of the test product up to 40g
• To determine the maximum tolerated dose (MTD)
• To support the administration of the recommended dose for Part 2 of the study in healthy subjects
• To evaluate the immunogenicity of Navalbumin.
Part 2:
Primary objective:
• To evaluate the pharmacokinetics of Navalbumin as compared to Human Albumin in healthy adult human subjects
Secondary objective:
• To evaluate the pharmacodynamics and immunogenicity of Navalbumin as compared to Human Albumin.
• To assess the safety and tolerability of the investigational products
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
• To determine the maximum tolerated dose (MTD)
时间窗: Pharmacokinetic Blood sampling: | On day 1: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 22: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 43: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0, 192.0, 360.0, 528.0, 768.0 and 1152.0 hours
• To support the administration of the recommended dose for Part 2 of
时间窗: Pharmacokinetic Blood sampling: | On day 1: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 22: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 43: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0, 192.0, 360.0, 528.0, 768.0 and 1152.0 hours
Part 1:
时间窗: Pharmacokinetic Blood sampling: | On day 1: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 22: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 43: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0, 192.0, 360.0, 528.0, 768.0 and 1152.0 hours
• To establish safety and tolerability of the test product up to 40g
时间窗: Pharmacokinetic Blood sampling: | On day 1: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 22: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 43: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0, 192.0, 360.0, 528.0, 768.0 and 1152.0 hours
the study in healthy subjects
时间窗: Pharmacokinetic Blood sampling: | On day 1: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 22: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 43: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0, 192.0, 360.0, 528.0, 768.0 and 1152.0 hours
• To evaluate the immunogenicity of Navalbumin.
时间窗: Pharmacokinetic Blood sampling: | On day 1: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 22: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 43: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0, 192.0, 360.0, 528.0, 768.0 and 1152.0 hours
Part 2:
时间窗: Pharmacokinetic Blood sampling: | On day 1: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 22: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 43: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0, 192.0, 360.0, 528.0, 768.0 and 1152.0 hours
To evaluate the pharmacokinetics of Navalbumin as compared to Human Albumin in healthy adult human subjects
时间窗: Pharmacokinetic Blood sampling: | On day 1: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 22: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours | On day 43: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0, 192.0, 360.0, 528.0, 768.0 and 1152.0 hours
次要结局
- • To evaluate the pharmacodynamics and immunogenicity of Shilpa Recombinant Human Albumin as compared to Human Albumin.(• To assess the safety and tolerability of the investigational products)