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Healthy VolunteersPhase 1ARGX-117NCT04532125

SAD and MAD Study With IV and SC Doses of ARGX-117

A Phase 1 study testing ARGX-117, ARGX-117 + rHuPH20 and ARGX-117 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 is a phase 1, first-in-human, double-blinded, randomized, placebo-controlled, escalating single and multiple dose levels trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ARGX-117 administered IV and/or SC. 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?
ARGX-117, ARGX-117 + rHuPH20 and ARGX-117 PH20 SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteNetherlands
Study dates
3 Aug 2020to 26 Aug 2022
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 to 65 years of age, inclusive, at the time the informed consent form (ICF) is signed.
  • The subject is either male, or female of nonchildbearing potential. Females in the following categories are considered a woman of nonchildbearing potential:
  • Postmenopausal female: A postmenopausal state is defined as continuous amenorrhea for at least 1 year without an alternative medical cause and a follicle-stimulating hormone (FSH) measurement of >40 IU/L. A historical pretreatment FSH measurement of>40 IU/L is accepted as proof of a postmenopausal state for subjects on hormone replacement therapy.
  • Surgically sterile female: women who have had a documented permanent sterilization procedure (ie, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
  • Female subjects must have a negative serum pregnancy test on day -1 before IMP can be administered.
  • The subject has a body mass index (BMI) within the range 18 to 30 kg/m2 and body weight 50 to 100 kg (inclusive) before IMP administration.
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  • The subject is able to understand the requirements of the study and provide written informed consent (including consent for the use and disclosure of research-related health information), and is willing and able to comply with the study protocol procedures (including the required study visits).
  • The subject is in good physical and mental health, per the opinion of the investigator, based on medical history; physical examination findings; ECG recordings; vital sign measurements; systemic lupus erythematous (SLE) panel results; and biochemistry, hematology, INR, and urinalysis laboratory test results prior to the first dose of IMP on day 1.
  • Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use effective contraception from the signing of the ICF through 260 days after the last IMP administration. A male subject practicing true sexual abstinence (as consistent with the preferred and usual lifestyle) can be included. Sterilized male subjects who have had a vasectomy and with documented absence of sperm post-procedure can be included. Male subjects are not allowed to donate sperm from signing of the ICF through 260 days after the last dose of IMP.
  • The subject has abdominal skin that, in the opinion of the investigator, allows for the absorption and localized safety assessment of SC administration (applicable for dose levels with SC administration only).
  • The subject agrees to discontinue and refrain from the use of all medications, including nonprescription and/or prescription medications, for at least 2 weeks before the first dose of IMP through the EOS visit on day 260 (Part A [SAD]), day 288 (Part B [MAD], cohorts 1 through 5). The occasional use of paracetamol at doses up to 2 g/day with a maximum of 10 g/2 weeks is allowed upon approval from the investigator. COVID-19 immunization recommendations are described in Section 4.3.1.1.
  • The subject is a nonsmoker and does not use any nicotine-containing products. A nonsmoker is defined as an individual who has abstained from smoking for at least 3 months prior to screening.
  • The subject has a negative urine drug and alcohol screen for amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants and alcohol at screening and on day -1.
  • The subject has a body temperature of 35.5 °C to 37.6 °C at screening and prior to the first dose of IMP day 1.

Who cannot join

  • The subject has a known hypersensitivity to any of the components of the IMP, or, in the opinion of the investigator, a history of a significant allergic reaction to any drug.
  • The subject has previously participated in a clinical study with efgartigimod and was administered an IMP.
  • The subject has a positive serum test at screening for an active viral infection with any of the following conditions:
  • Hepatitis B virus (HBV) that is indicative of an acute or chronic infection (https://www.cdc.gov/hepatitis/HBV/PDFs/SerologicChartv8.pdf)
  • Hepatitis C virus (HCV) based on HCV antibody assay
  • Human immunodeficiency virus
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  • The subject tests positively at screening for SLE as determined by the SLE test panel.
  • The subject has a known family history of SLE.
  • The subject has known clinically relevant immunological disorders.
  • The subject has a history of severe allergic or anaphylactic reactions.
  • The subject has clinical evidence of significant serious diseases, underwent a recent major surgery, or has any other condition that, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk. The conditions and diseases that will lead to subject exclusion include recognized uncontrolled risk factors associated with acute respiratory distress syndrome (ARDS) and death in subjects with COVID-19 (eg, hypertension, diabetes, asthma, or chronic obstructive pulmonary disease [COPD]).
  • The subject has a clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening.
  • The subject has the presence or sequelae of gastrointestinal, liver, kidney, or other conditions known to potentially interfere with the absorption, distribution, metabolism, or excretion of IMP.
  • The subject has an estimated glomerular filtration rate of <80 mL/min/1.73 m² (calculated per the Chronic Kidney Disease Epidemiology Collaboration method) at screening.
  • The subject has a history of malignancy except for:
  • Adequately treated basal cell or squamous cell skin cancer
  • Carcinoma in situ of the cervix
  • The subject has known genetic deficiencies for the complement cascade system.
  • The subject has clinically relevant abnormalities detected on an ECG that are related to either rhythm or conduction (eg, QTcF >450 ms for male and QTcF >470 ms for female subjects, or a known long QT syndrome).
  • The subject has clinically relevant vital sign abnormalities before the first dose of IMP.
  • The subject had significant blood loss, including blood donation >500 mL, or transfusion of any blood product within 12 weeks before the first dose of IMP, or the subject has a scheduled transfusion within 4 weeks after the end of the study.
  • The subject has received treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months before the first dose of IMP.
  • The subject has a history of any of the following:
  • consuming more than 21 units of alcoholic beverages per week (Note: 1 unit is 330 mL of beer, 110 mL of wine, or 28 mL of spirits)
  • alcoholism or drug, chemical, substance abuse within 2 years before screening
  • consuming a large quantity (>6 cups per day) of coffee, tea, or the equivalent in the 4 weeks before the first dose of IMP.
  • The subject is concurrently participating or has participated, within 90 days before the first dose of IMP or, if known, 5 half-lives of the investigational drug (whichever is longer), in any drug/device or biologic investigational research study.
  • The subject has been administered any systemic immunosuppressant agent within 6 months prior to the first dose of IMP.
  • The subject has been administered any systemic steroid within 3 months prior to the first dose of IMP.
  • The subject is an investigator, subinvestigator, research assistant, pharmacist, study coordinator, or other staff or relative of study personnel directly involved with the conduct of the study.
  • 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 is a pregnant or lactating female, or intends to become pregnant during the study or within 260 days after the last dose of IMP.
  • The subject has any condition that impairs phlebotomy.
  • The subject has a positive nasopharyngeal polymerase chain reaction (PCR) test for SARS-CoV-2 on day -2 or -1.
  • The subject has any contact with anyone who has tested positive for SARS-CoV-2 or COVID-19 within the last 2 weeks prior to admission to the clinical research center.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Investigator Site 1

    Groningen

Other trials in Netherlands

About this study

Official title: First-In-Human, Randomized, Double-Blinded, Placebo-Controlled Trial in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of ARGX-117 Co-mixed With rHuPH20

This is a phase 1, first-in-human, double-blinded, randomized, placebo-controlled, escalating single and multiple dose levels trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ARGX-117 administered IV and/or SC. Up to 112 healthy, adult male and female subjects of non-childbearing potential will be enrolled in this trial.

Being tested
ARGX-117, Placebo, ARGX-117 + rHuPH20, placebo + rHuPH20, ARGX-117 PH20 SC

What participants receive

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

  • ARGX-117Biological

    Subjects treated with ARGX-117

  • PlaceboOther

    Subjects treated with placebo

  • ARGX-117 + rHuPH20Biological

    Subjects treated with ARGX-117 + rHuPH20

  • placebo + rHuPH20Other

    Subjects treated with placebo + rHuPH20

  • ARGX-117 PH20 SCBiological

    Subjects treated with ARGX-117 PH20 SC

  • Placebo PH20 SCOther

    Subjects treated with placebo PH20 SC

Study groups in NCT04532125
Study groupRoleWhat they receive
ARGX-117 IVExperimentalSubjects receiving ARGX-117 IV
Receives: Biological: ARGX-117
Placebo IVPlacebo comparatorSubjects receiving placebo IV
Receives: Other: Placebo
ARGX-117 PH20 SCExperimentalSubjects receiving ARGX-117 PH20 SC
Receives: Biological: ARGX-117 PH20 SC
Placebo PH20 SCPlacebo comparatorSubjects receiving placebo PH20 SC
Receives: Other: Placebo PH20 SC
ARGX-117 + rHuPH20ExperimentalSubjects receiving ARGX-117 + rHuPH20
Receives: Biological: ARGX-117 + rHuPH20
Placebo + rHuPH20Placebo comparatorSubjects receiving placebo + rHuPH20
Receives: Other: placebo + rHuPH20

What is being measured

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

  1. Number of (S)AE

    Measured: Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)

Secondary outcomes (7)

  1. Area Under The Curve (AUC)

    Measured: Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)

  2. Maximum serum concentrations (Cmax)

    Maximum observed serum concentration

    Measured: Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)

  3. Time to reach maximum serum concentrations (Tmax)

    Time calculated to reach Cmax

    Measured: Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)

  4. Free C2 concentration

    Functional complement activity

    Measured: Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)

  5. Total C2 concentration

    Functional complement activity

    Measured: Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)

  6. CH50 titers

    Functional complement activity

    Measured: Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)

  7. Level of anti-drug antibodies

    Immunogenicity against ARGX-117

    Measured: Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)

Timeline

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

  1. First posted31 Aug 2020
  2. Study start3 Aug 2020
  3. Primary completion26 Aug 2022
  4. Study completion26 Aug 2022

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
Other
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04532125
Sponsor's protocol ID
ARGX-117-1901
Acronym
ARGX-117
Status last verified
Sep 2022
First submitted
26 Aug 2020
Last updated
21 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ARGX-117, ARGX-117 + rHuPH20 and ARGX-117 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 14 inclusion and 35 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 21 Sep 2022. 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. Some participants in this study may receive a placebo. 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?

Number of (S)AE (time frame: Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)). 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 NCT04532125.

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 21 Sep 2022.

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