NCT06268860已完成1 期
A Phase 1 Open-label, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
研究概览
简要总结
The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rocatinlimab Vial
Experimental
Participants will receive rocatinlimab vial solution SC
干预措施: Rocatinlimab vial injection (Drug)
Rocatinlimab Prefilled Syringe
Experimental
Participants will receive rocatinlimab prefilled syringe solution SC
干预措施: Rocatinlimab prefilled syringe (Combination Product)
结局指标
主要结局
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
时间窗: Up to Day 112
Maximum Observed Serum Concentration (Cmax) of Rocatinlimab
时间窗: Up to Day 112
AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
时间窗: Up to Day 112
次要结局
- Number of Participants Experiencing Serious Adverse Events (SAE)(Up to approximately 20 weeks)
- Number of Participants Positive to Anti-rocatinlimab Antibody(Up to Day 112)
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)(Up to approximately 20 weeks)
研究者
研究点 (4)
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