IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers

NCT03457649 | Completed Phase 1

• 1 other identifier: ARGX-113-1501
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

A phase 1 study in healthy volunteers (female and male) to evaluate through SAD and MAD, the safety, PK, PD and immunogenicity of ARGX-113 administered intravenously.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of (related) treatment emergent AE of single ascending dose of ARGX-113

  Determining the incidence, severity, and dose relationship of adverse events that are related to treatment with ARGX-113

  57 days

Secondary Outcomes (1)

• Number of (related) treatment emergent AE of multiple ascending doses of ARGX-113

  78 days

Study Arms (2)

ARGX-113

ACTIVE COMPARATOR

SAD and MAD with test product at different increasing doses

Biological: ARGX-113

Placebo

PLACEBO COMPARATOR

SAD and MAD with placebo at different increasing doses

Biological: Placebo

Interventions

ARGX-113 BIOLOGICAL

ARGX-113

Placebo BIOLOGICAL

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects meeting all of the following criteria are eligible to participate in this study:
• Willingness and ability to understand the purpose and risks of the study and provide signed and dated informed consent prior to any procedures and be available for all study visits.
• Male or female of non-child bearing potential, between 18-55 years of age, inclusive, on the day of signing the Informed Consent Form (ICF).
• Body mass index (BMI) between 18-30 kg/m2, inclusive with a weight of at least 50 kg and no more than 100 kg.
• Female subjects must have a negative blood pregnancy test at screening and a negative urine pregnancy test at Day -1.
• Female subjects who are postmenopausal or surgically sterile (having had a hysterectomy, bilateral oophorectomy, or tubal ligation). Determination of serum follicle-stimulating hormone (FSH) will be done with FSH levels \> 35 mIU/mL being confirmative for menopause. For hysterectomy and tubal ligation, documented confirmation will be requested.
• 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.
• Male 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.
• Discontinuation of all medications (including over-the-counter and/or prescription medication, dietary supplements, neutraceuticals, vitamins and/or herbal supplements such as Ginkgo biloba or Saint John's wort), 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.
• Non-smokers, 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 the screening.
• Negative urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) at screening and Day -1.
• Negative alcohol breath test at screening and Day-1. Note: A retest can be done in case of an out of range clinical laboratory test value that will determine a subject's eligibility. This retest should preferably be done at an unscheduled visit. The result of the retest will be considered for subject eligibility. If the retest is outside normal reference ranges, the subject may be included only if the investigator judges the abnormalities to be not clinically significant.

You may not qualify if:

• Subjects meeting any of the following criteria are excluded from participation in this study:
• Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
• Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A.
• History of or a current immunosuppressive condition (e.g., human immunodeficiency virus \[HIV\] infection).
• History of or evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) diagnosed by a positive QuantiFERON® TB-Gold In Tube test or a positive tuberculin skin test ("Mantoux") in case of a weak positive QuantiFERON® TB-Gold In Tube test.
• Subjects with known clinically relevant immunological disorders.
• History of severe allergic or anaphylactic reactions.
• Symptoms of clinically significant illness in the 3 months before the initial 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 \[male subjects\] or \>470 \[female subjects\], 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
• 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 (14 for females) 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.

Sponsors & Collaborators

• argenx: lead

Related Publications (1)

• Ulrichts P, Guglietta A, Dreier T, van Bragt T, Hanssens V, Hofman E, Vankerckhoven B, Verheesen P, Ongenae N, Lykhopiy V, Enriquez FJ, Cho J, Ober RJ, Ward ES, de Haard H, Leupin N. Neonatal Fc receptor antagonist efgartigimod safely and sustainably reduces IgGs in humans. J Clin Invest. 2018 Oct 1;128(10):4372-4386. doi: 10.1172/JCI97911. Epub 2018 Jul 24.

  PMID: 30040076 DERIVED

MeSH Terms

Interventions

efgartigimod alfa

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SAD MAD

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: March 7, 2018
• Study Start: September 9, 2015
• Primary Completion: November 15, 2016
• Study Completion: February 21, 2017
• Last Updated: May 23, 2024

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share