| Eligibility |
Inclusion Criteria:
1. The subject is between 18 and 65 years of age, inclusive, on the day when the ICF is
signed.
2. The subject is either male or female of non-childbearing potential (postmenopausal
[defined by continuous amenorrhea for at least 1 year without an alternative medical
cause with a follicle-stimulating hormone (FSH) of >33.4 IU/L; in subjects on hormonal
replacement therapy, a historical value pretreatment of >33.4 IU/L will be accepted as
proof of menopausal status]) OR have a documented permanent sterilization procedure
(ie, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
3. The female subject has a negative pregnancy test at day -1
4. The subject has a body mass index (BMI) between 18 and 30 kg/m2, inclusively, with a
weight of =50 kg and =100 kg at screening.
5. The subject is able to understand the requirements of the study, provide written
informed consent (including consent for the use and disclosure of research-related
health information), willing and able to comply with the protocol procedures
(including required study visits).
6. The subject is in good physical and mental health, per the opinion of the
investigator, based on medical history, physical examination, ECG, and vital sign
findings; and biochemistry, hematology, virology, and urinalysis test results prior to
the first IMP administration.
7. The non-sterilized male subject who is sexually active with a female partner of
childbearing potential must use effective contraception (failure rate of <1% per
year). Male subject practicing true sexual abstinence (when consistent with the
preferred and usual life style of the participant) can be included. The sterilized
male subject who has had a vasectomy with documented aspermia postprocedure can be
included. In addition, no male subject will be allowed to donate sperm during the
period from signing the ICF, throughout the duration of the trial, and 90 days after
the last administration of the IMP.
8. The condition of the skin tissue on the subject's abdomen must allow for absorption
and assessment of local safety of the planned SC injection, as determined by the
investigator.
9. The subject agrees to discontinue and refrain from all medications (including
over-the-counter and/or prescription medications), except for occasional paracetamol
use (maximum dose of 2 g/day and maximum of 10 g/2 weeks), antacid use, and ibuprofen
use (maximum dose of 400 mg/day and not to be coadministered with antacid), at least 2
weeks before the first IMP administration through the final follow-up visit on day 78.
10. The subject agrees to withhold from strenuous activities from at least 2 weeks before
the first IMP administration through the final follow-up visit on day 78.
11. The subject is a non-smoker and does not use 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.
12. The subject has a negative nicotine analyte test at screening and on day -1.
13. The subject has a negative urine drug screen (amphetamines, barbiturates,
benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants)
at screening and on day -1.
14. The subject has a negative alcohol urine test at screening and on day -1.
15. The subject has a body temperature of 35.2°C to 37.6 °C at screening and on day -1.
Exclusion Criteria:
1. The subject has previously participated in clinical studies with efgartigimod
(ARGX-113) and was administered an IMP.
2. The subject has a known hypersensitivity to 1 of the components in the IMP, or a
history of severe allergic or anaphylactic reactions, in the opinion of the
investigator.
3. The subject tests positively at screening for any of the following conditions: a. The
subject has an active hepatitis B infection (acute or chronic) at screening as
determined by hepatitis B serology.
b. The subject has serology positive for hepatitis C virus antibody (HCV Ab). c. The
subject has human immunodeficiency virus (HIV) positive serology.
4. Subjects with clinically significant active or chronic uncontrolled bacterial, viral,
or fungal infection at screening.
5. Subjects with clinical evidence of other significant serious diseases, subjects who
underwent a recent major surgery, or any other reason which could confound the results
of the trial or put the subject at undue risk.
6. The subject has total IgG <6 g/L at screening.
7. The subject has presence or sequelae of gastrointestinal, liver, kidney, or any other
condition known to potentially interfere with the absorption, distribution,
metabolism, or excretion of IMP.
8. The subject has a history of malignancy unless deemed cured by adequate treatment with
no evidence of recurrence for =3 years before first IMP administration. Subjects with
the following cancer can be included anytime:
1. Adequately treated basal cell or squamous cell skin cancer
2. Carcinoma in situ of the cervix
3. Carcinoma in situ of the breast or
4. Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
9. The subject has a clinically relevant abnormality detected on ECG recording regarding
either rhythm or conduction (eg, QTcF >450 ms for male and QTcF >470 ms for female
subjects, or a known long QT syndrome). A first-degree heart block or sinus arrhythmia
will not be considered a significant abnormality.
10. The subject has clinically relevant abnormalities detected in vital sign measurements
prior to dosing.
11. The subject has significant blood loss (including blood donation >500 mL) or has had a
transfusion of any blood product within 12 weeks prior to the (first) IMP
administration or a scheduled transfusion within 4 weeks after the end of the study.
12. The subject has been treated with any drug known to have a well-defined potential for
toxicity to a major organ in the last 3 months preceding the initial IMP
administration.
13. The subject has a history of consuming more than 21 units of alcoholic beverages per
week or a history of alcoholism or drug/chemical/substance abuse within 2 years prior
to screening (Note: 1 unit = 330 mL of beer, 110 mL of wine or 28 mL of spirits).
Regular consumption of a large quantity of coffee, tea ( >6 cups per day), or
equivalent within 3 weeks prior to first dose is also exclusionary.
14. The subject has received investigational drug within 3 months or 5 half-lives of the
drug (whichever is longer) prior to first IMP administration.
15. The subject has received a vaccination (eg, influenza vaccine) within the last 4 weeks
prior to screening.
16. The subject has received any systemic immunosuppressant agent within 6 months prior to
the initial IMP administration.
17. The subject has received any systemic steroid within 3 months prior to the initial IMP
administration.
18. The subject has received any monoclonal antibody, within 6 months prior to first IMP
administration.
19. The subject is an employee of the investigator or study center, with direct
involvement in the proposed study or other studies under the direction of that
investigator or study center, as well as a family member of an employee or the
investigator.
20. The subject has 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.
21. The subject has any condition impairing phlebotomy.
22. The subject is a pregnant or lactating women or intending to become pregnant during
the study or within 90 days after last dosing.
23. The subject has a positive nasopharyngeal PCR test for SARS-CoV-2 on days -2 or -1.
24. The subject has had any contact with SARS-CoV-2 positive or COVID-19 patients
within the last 2 weeks prior to admission to the clinical research center.
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