NCT04177290已完成1 期
A Phase I PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- PK is defined as AUC0-∞.
研究概览
简要总结
this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
sintilimab (M1b) 200mg
Experimental
干预措施: Sintilimab (M1b) (Drug)
sintilimab (approved) 200mg
Active Comparator
干预措施: Sintilimab (approved) (Drug)
结局指标
主要结局
PK is defined as AUC0-∞.
时间窗: 28 days
次要结局
- PK is defined as Cmax.(28 days)
- Safety of sintilimab (approved) versus sintilimab (M1b). AE is defined as treatment-related adverse events assessed by CTCAE v5.0.(from randomization through 90 days after last dosing)
研究者
研究点 (1)
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