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

argenx1 site in 1 country40 target enrollmentOctober 11, 2017

ConditionsBioavailability Study

InterventionsARGX-113

DrugsARGX-113

Overview

Phase: Phase 1
Intervention: ARGX-113
Conditions: Bioavailability Study
Sponsor: argenx
Enrollment: 40
Locations: 1
Primary Endpoint: bioavailability of a s.c. ARGX-113 formulation
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 of ARGX-113 in Healthy Male Subjects

Registry

clinicaltrials.gov

Start Date

October 11, 2017

End Date

September 19, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

argenx

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

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.