2025-522534-31-00招募中1 期
A single dose, randomized, double-blind 2-arm parallel-group study to compare the pharmacokinetics, immunogenicity, and safety for PB016 versus US-licensed Entyvio® after subcutaneous administration in healthy participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
研究概览
简要总结
暂无简介。
入排标准
- 年龄范围
- 18 years 至 64 years(18-64 Years)
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究者
Agnes Rethy
Scientific
Polpharma Biologics S.A.
研究点 (1)
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