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Healthy VolunteersPhase 1NCT04564066

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

A Phase 1 study testing efgartigimod IV and efgartigimod PH20 SC in people with Healthy Volunteers, run by argenx at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
efgartigimod IV and efgartigimod PH20 SC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteNetherlands
Study dates
18 Aug 2020to 11 Feb 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
  • 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.
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  • 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.
  • 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.
  • 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.
  • 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.
  • The subject has received investigational drug within 3 months or 5 half-lives of the drug (whichever is longer) prior to first IMP administration.
  • The subject has received a vaccination (eg, influenza vaccine) within the last 4 weeks prior to screening.
  • The subject has received any systemic immunosuppressant agent within 6 months prior to the initial IMP administration.
  • The subject has received any systemic steroid within 3 months prior to the initial IMP administration.
  • The subject has received any monoclonal antibody, within 6 months prior to first IMP administration.
  • 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.
  • 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.
  • The subject has any condition impairing phlebotomy.
  • The subject is a pregnant or lactating women or intending to become pregnant during the study or within 90 days after last dosing.
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Study Site 1

    Groningen

Other trials in Netherlands

About this study

Official title: A Phase 1, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Multiple Intravenous Infusions of Efgartigimod With Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Healthy Subjects

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

Being tested
efgartigimod IV, efgartigimod PH20 SC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • efgartigimod IVBiological

    intravenous infusions of efgartigimod

  • efgartigimod PH20 SCBiological

    subcutaneous injections of efgartigimod PH20 SC

Study groups in NCT04564066
Study groupRoleWhat they receive
efgartigimod IVExperimentalintravenous infusions of efgartigimod
Receives: Biological: efgartigimod IV
efgartigimod PH20 SCExperimentalsubcutaneous injections of efgartigimod PH20 SC
Receives: Biological: efgartigimod PH20 SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: After four weeks (day 29)

Secondary outcomes (16)

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

    Measured: Up to 15 weeks

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

    Measured: Up to 15 weeks

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

    Measured: Up to 15 weeks

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

    Measured: Up to 15 weeks

  5. 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)

    Measured: Up to 11 weeks

  6. AUEC for percentage reduction in IgG levels for each subtype 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)

    Measured: Up to 11 weeks

  7. Serum levels of efgartigimod and derived PK parameters

    Measured: Up to 15 weeks

  8. Cmax of efgartigimod

    Measured: Up to 15 weeks

  9. Ctrough of efgartigimod

    Measured: Up to 15 weeks

  10. Lymphocyte count

    Measured: Up to 15 weeks

  11. Neutrophil count

    Measured: Up to 15 weeks

  12. Monocyte count

    Measured: Up to 15 weeks

  13. Vital sign measurement: blood pressure

    Measured: Up to 15 weeks

  14. Vital sign measurement: heart rate

    Measured: Up to 15 weeks

  15. ECG recording of QTcF

    Measured: Up to 15 weeks

  16. Incidence and characterization of TEAEs

    Measured: Up to 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2020
  2. Study start18 Aug 2020
  3. Primary completion24 Dec 2020
  4. Study completion11 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04564066
Sponsor's protocol ID
ARGX-113-1907
Status last verified
Mar 2021
First submitted
11 Sep 2020
Last updated
5 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing efgartigimod IV and efgartigimod PH20 SC in people with Healthy Volunteers, run by argenx at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: After four weeks (day 29)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04564066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.

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