NCT03334084已完成1 期
A Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy Male 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
- argenx
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- bioavailability of a s.c. ARGX-113 formulation
研究概览
简要总结
The study is a Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy 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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, between 18-55 years of age.
- •Body mass index (BMI) between 18-30 kg/m
- •Willingness and ability to understand the purpose and risks of the study and provide signed and dated informed consent.
- •Non-vasectomized male subjects having a female partner of childbearing potential must agree to the use of an effective method of contraception until 90 days after the last administration of study drug.
- •Subjects have to agree not to donate sperm until 90 days after the last administration of study drug.
- •Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory findings.
- •Agree to discontinue and refrain from intake of all medications, except occasional paracetamol use (maximum dose of 2 g/day and maximum of 10 g/2 weeks), at least 2 weeks prior to the first study drug administration. In addition, subjects must agree to the prohibitions and restrictions for this study.
- •Subject is a non-smoker, and not using any nicotine containing products. A non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to Screening.
排除标准
- •Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- •Active infection; a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to screening.
- •Subjects with known clinically relevant immunological disorders.
- •History of severe allergic or anaphylactic reactions.
- •Known history or any symptom of clinically significant illness in the 6 months before the first study drug administration.
- •Presence or having sequelae of gastrointestinal, liver, kidney or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •History of malignancy within the past 5 years (except for basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- •Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g., QTcF > 450 ms [millisecond], or a known long QT syndrome). A first degree heart block or sinus arrhythmia will not be considered as a significant abnormality.
- •Clinically relevant abnormalities detected on vital signs prior to first dosing.
- •Significant blood loss (including blood donation [> 500 mL]), or had a transfusion of any blood product within 12 weeks prior to the initial study drug administration or plan one within 4 weeks after the end of the study.
- •Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months preceding the initial study drug administration.
- •The subject has a history of consuming more than 21 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening (Note: one unit = 330 mL of beer, 110 mL of wine or 28 mL of spirits).
- •Consumption of a large quantity of coffee, tea (> 6 cups per day) or equivalent.
- •Concurrent participation or participation within 90 days prior to the initial study drug administration in a drug/device or biologic investigational research study.
- •Administration of a vaccine within 60 days prior to initial study drug administration.
- •Administration of any systemic immunosuppressant agent within 6 months prior to initial study drug administration.
- •Administration of any systemic steroid within 2 months prior to initial study drug administration.
- •Administration of an injectable drug within 30 days prior to the initial study drug administration.
- •Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof who is directly involved in the conduct of the study.
- •Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
- •Unsuitable vein for infusion and/or blood sampling.
研究组 & 干预措施
1
Experimental
Scheme 1
干预措施: ARGX-113 (Drug)
2
Experimental
Scheme 2
干预措施: ARGX-113 (Drug)
3
Experimental
Scheme 3
干预措施: ARGX-113 (Drug)
结局指标
主要结局
bioavailability of a s.c. ARGX-113 formulation
时间窗: 1.5 months
AUC0-inf
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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