NCT04073589已完成1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- argenx
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- IgG levels of four different subcutaneous dose levels
研究概览
简要总结
The aim of this trial is to investigate the pharmacodynamic (PD), pharmacokinetic (PK), safety, tolerability, and immunogenicity of efgartigimod co-administered with rHuPH20, and to measure the time to inject the full dose of investigational medicinal product (IMP) of different dose levels of efgartigimod co-administered with a fixed concentration of rHuPH20 by the subcutaneous (SC) route of administration in healthy adult male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is male, between 18 to 70 years of age
- •Subject is healthy
- •Subject has a body mass index (BMI) between 18 kg/m2 to 30 kg/m2
- •Subject is willing and able to understand the purpose and risks of the trial and provide signed and dated informed consent,
- •Others as defined in the protocol
排除标准
- •Previous participation in clinical trials with efgartigimod and/or any products with rHuPH
- •Known hypersensitivity to IMP ingredients or history of a severe allergic or anaphylactic reaction to any drug as determined by the investigator.
- •Known seropositivity or positive test at screening for an active viral infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human immunodeficiency virus (HIV).
- •Known clinically relevant immunological disorders.
- •Known history or any symptom of clinically significant illness in the 6 months before IMP administration.
- •Others as defined in the protocol
结局指标
主要结局
IgG levels of four different subcutaneous dose levels
时间窗: Up to 11 weeks, from study start until the end of the study
次要结局
- Level of anti-drug antibodies(Up to 11 weeks, from study start until the end of the study)
- Time required to administer the different doses(Up to 11 weeks, from study start until the end of the study)
- Maximum serum concentrations (Cmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20(Up to 11 weeks, from study start until the end of the study)
- Area Under The Curve (AUC) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20(Up to 11 weeks, from study start until the end of the study)
- Time to reach maximum serum concentrations (Tmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20(Up to 11 weeks, from study start until the end of the study)
- Number of (serious) adverse events(Up to 11 weeks, from study start until the end of the study)
研究者
研究点 (1)
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