NL-OMON48123已完成不适用
A phase 1, randomized, open-label, parallel group trial to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of different single subcutaneous dose levels of Efgartigimod co administered with rHuPH20 in healthy adult male subjects - Efgartigimod co-administered with rHuPH20 in healthy subjects
argenx BVBA0 个研究点目标入组 32 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- healthy male subjects
- •- 18-70 yrs, inclusive
- •- BMI: 18.0-30.0 kg/m2, inclusive and with a body weight of at least 50 kg and
- •no more than 100 kg prior to dosing.
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Previous
- •participation in clinical trials with efgartigimod (ARGX-113) and/or any
- •products co-formulated with rHuPH20. Significant blood loss (including blood
- •donation >500 mL) or transfusion of any blood product within 12 weeks prior to
- •the IMP administration or scheduled transfusion within 4 weeks after the end of
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