Status:
COMPLETED
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
Lead Sponsor:
argenx
Conditions:
Bioavailability Study
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03334084
Start Date
October 11 2017
End Date
September 19 2018
Last Update
August 31 2020
Active Locations (1)
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1
QPS Netherlands B.V.
Groningen, Netherlands