NL-OMON49985已完成不适用
A phase 1, randomized, open-label, parallel-group study to compare the pharmacodynamics, pharmacokinetics, safety, and tolerability of multiple intravenous infusions of efgartigimod with multiple subcutaneous injections of efgartigimod PH20 SC in healthy subjects. - Comparing PK, PD, safety of efgartigimod SC and IV.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- argenx BV
- 入组人数
- 54
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, adult males and females of non-childbearing potential between 18-65
- •years of age, inclusively, with a BMI between 18-30 kg/m2, and body weight
- •between 50-100 kg.
排除标准
- •1. The subject has previously participated in clinical studies with
- •efgartigimod (ARGX-113).
- •2. The subject has a known hypersensitivity to one of the components in the
- •IMP, or a history of severe allergic or anaphylactic reactions, in the opinion
- •of the investigator.
- •3. The subject tests positively at screening for any of the following
- •conditions:
- •a. an active hepatitis B infection (acute or chronic) at screening as
- •determined by HepB serology
- •b. Hepatitis C Virus (HCV): serology positive for HCV-Ab
- •c. HIV positive serology
- •4. Subjects with clinically significant active or chronic uncontrolled
- •bacterial, viral, or fungal infection at screening.
- •5. Subjects with clinical evidence of other significant serious diseases,
- •subjects who underwent a recent major surgery, or any other reason which could
- •confound the results of the trial or put the subject at undue risk.
- •For more exclusion criteria see Protocol.
研究者
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