A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigimod as a Subcutaneous Injection in Healthy Volunteers

NCT04564066 | Completed Phase 1

• 1 other identifier: ARGX-113-1907
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in total IgG levels, compared to baseline, at day 29 (week 4), 7 days after the fourth IV or SC administration of efgartigimod

  After four weeks (day 29)

Secondary Outcomes (16)

• Percentage reduction in total IgG levels at all other assessment timepoints as of week 4

  Up to 15 weeks

• Percentage reduction in levels of IgG subtypes (IgG1, IgG2, IgG3, and IgG4) at all assessment timepoints

  Up to 15 weeks

• Absolute values and changes from baseline in total IgG levels at all assessment timepoints

  Up to 15 weeks

• Absolute values and changes from baseline in levels of IgG subtypes (IgG1, IgG2, IgG3, and IgG4) at all assessment timepoints

  Up to 15 weeks

• AUEC for percentage reduction in total IgG levels per weekly interval after each dose (week 1, week 2, week 3, and week 4), over the interval week 1 to week 4, and over the entire study period (week 1 to week 11)

  Up to 11 weeks

Study Arms (2)

efgartigimod IV

EXPERIMENTAL

intravenous infusions of efgartigimod

Biological: efgartigimod IV

efgartigimod PH20 SC

EXPERIMENTAL

subcutaneous injections of efgartigimod PH20 SC

Biological: efgartigimod PH20 SC

Interventions

efgartigimod IV BIOLOGICAL

intravenous infusions of efgartigimod

efgartigimod IV

efgartigimod PH20 SC BIOLOGICAL

subcutaneous injections of efgartigimod PH20 SC

efgartigimod PH20 SC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is between 18 and 65 years of age, inclusive, on the day when the ICF is signed.
• 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).
• The female subject has a negative pregnancy test at day -1
• 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.
• 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).
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• The subject has a negative nicotine analyte test at screening and on day -1.
• The subject has a negative urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) at screening and on day -1.
• The subject has a negative alcohol urine test at screening and on day -1.
• The subject has a body temperature of 35.2°C to 37.6 °C at screening and on day -1.

You may not qualify if:

• The subject has previously participated in clinical studies with efgartigimod (ARGX-113) and was administered an IMP.
• 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.
• 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.
• Subjects with clinically significant active or chronic uncontrolled bacterial, viral, or fungal infection at screening.
• 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.
• The subject has total IgG \<6 g/L at screening.
• 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.
• 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:
• Adequately treated basal cell or squamous cell skin cancer
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast or
• Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
• 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.
• The subject has clinically relevant abnormalities detected in vital sign measurements prior to dosing.

Sponsors & Collaborators

• argenx: lead

Study Sites (1)

Study Site 1

Groningen, Netherlands

Location

Study Design

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

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 25, 2020
• Study Start: August 18, 2020
• Primary Completion: December 24, 2020
• Study Completion: February 11, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-03

Locations

NL (1)