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

NCT03334084 | Completed Phase 1

• 1 other identifier: ARGX-113-1702
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Bioavailability Study

Outcome Measures

Primary Outcomes (1)

• bioavailability of a s.c. ARGX-113 formulation

  AUC0-inf

  1.5 months

Study Arms (3)

1

EXPERIMENTAL

Scheme 1

Drug: ARGX-113

2

EXPERIMENTAL

Scheme 2

Drug: ARGX-113

3

EXPERIMENTAL

Scheme 3

Drug: ARGX-113

Interventions

ARGX-113 DRUG

intravenous or subcutaneous administration

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• argenx: lead

Study Sites (1)

QPS Netherlands B.V.

Groningen, Netherlands

Location

MeSH Terms

Interventions

efgartigimod alfa

Study Officials

• Thierry Cousin, MD

  argenx

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 7, 2017
• Study Start: October 11, 2017
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)