Healthy VolunteersPhase 1NCT03457649
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
A Phase 1 study testing ARGX-113 in people with Healthy Volunteers, run by argenx.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ARGX-113
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2015to 21 Feb 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Administration of an injectable drug within 30 days prior to the initial study drug administration.
- Concurrent participation, or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study, or participation within 15 weeks prior to initial study drug administration in an investigational research study with biologic response modifier administration.
- Administration of a vaccine within 60 days prior to initial study drug administration.
- Administration of any systemic immunosuppressant agent within 6 months prior to initial study drug administration.
- Administration of any systemic steroid within 2 months prior to initial study drug administration;
- Use of a prohibited therapy within 14 days prior to initial study drug administration.
- Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof who is directly involved in the conduct of the study.
- 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.
- Pregnant or lactating women or women of childbearing potential.
- Unsuitable vein for infusion and/or blood sampling.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ARGX-113 in Healthy Males and Female Subjects
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.
Read the detailed description
The phase 1 in healthy volunteers include:
SAD with 5 doses of test product and placebo
MAD with 2 doses and two dosing intervals of the test product and placebo
The safety, pharmacokinetics, pharmacodynamics and immunogenicity of the test product are evaluated.
- Conditions
- Healthy Volunteers
- Being tested
- ARGX-113, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGX-113Biological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| ARGX-113 | Active comparator | SAD and MAD with test product at different increasing doses Receives: Biological: ARGX-113 |
| Placebo | Placebo comparator | SAD and MAD with placebo at different increasing doses Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 57 days
Secondary outcomes (1)
Number of (related) treatment emergent AE of multiple ascending doses of ARGX-113
Determining the incidence, severity, and dose relationship of adverse events that are related to treatment with ARGX-113
Measured: 78 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start9 Sep 2015
- Primary completion15 Nov 2016
- Study completion21 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- SAD MAD
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457649
- Sponsor's protocol ID
- ARGX-113-1501
- Status last verified
- Feb 2018
- First submitted
- 9 Feb 2018
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoefman S, van Steeg T, Ottevaere I, Baumeister J, Rossenu S. Translational population target binding model for the anti-FcRn fragment antibody efgartigimod. J Pharmacokinet Pharmacodyn. 2024 Dec 5;52(1):2. doi: 10.1007/s10928-024-09952-5.
PubMed 39636455Ulrichts 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.
PubMed 30040076
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ARGX-113 in Healthy Males and Female Subjects
- ClinicalTrials.gov ID
- NCT03457649
- Acronym / sponsor ID
- ARGX-113-1501
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2015 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The phase 1 in healthy volunteers include:
SAD with 5 doses of test product and placebo
MAD with 2 doses and two dosing intervals of the test product and placebo
The safety, pharmacokinetics, pharmacodynamics and immunogenicity of the test product are evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SAD MAD
| Arm | Type | Receives |
|---|---|---|
| ARGX-113 | Active comparator | Biological: ARGX-113SAD and MAD with test product at different increasing doses |
| Placebo | Placebo comparator | Biological: PlaceboSAD and MAD with placebo at different increasing doses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARGX-113 | Biological | ARGX-113 |
| Placebo | Biological | Placebo |
Primary outcome
Number of (related) treatment emergent AE of single ascending dose of ARGX-113
Time frame: 57 days
Determining the incidence, severity, and dose relationship of adverse events that are related to treatment with ARGX-113
1 secondary outcome
Number of (related) treatment emergent AE of multiple ascending doses of ARGX-113
Time frame: 78 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Derived from this study: PubMed 39636455Hoefman S, van Steeg T, Ottevaere I, Baumeister J, Rossenu S. Translational population target binding model for the anti-FcRn fragment antibody efgartigimod. J Pharmacokinet Pharmacodyn. 2024 Dec 5;52(1):2. doi: 10.1007/s10928-024-09952-5.
- Derived from this study: PubMed 30040076Ulrichts 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARGX-113 in people with Healthy Volunteers, run by argenx.
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 13 inclusion and 25 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 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 (related) treatment emergent AE of single ascending dose of ARGX-113 (time frame: 57 days). 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 NCT03457649, which also lists 2 linked publications.
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 23 May 2024.