A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male Subjects

Inclusion criteria

• Male, between 18-55 years of age.
• Body mass index (BMI) between 18-30 kg/m2.
• 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.

Exclusion criteria

• 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.