Bioavailability StudyPhase 1NCT03334084
A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male Subjects
A Phase 1 study testing ARGX-113 in people with Bioavailability Study, run by argenx at 1 site in Netherlands.
Trial summary
The study is a Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy Male Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability Study
- What is being tested?
- ARGX-113
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Oct 2017to 19 Sep 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, between 18-55 years of age.
- Body mass index (BMI) between 18-30 kg/m2.
- Willingness and ability to understand the purpose and risks of the study and provide signed and dated informed consent.
- 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.
- 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.
- Agree to discontinue and refrain from intake of all medications, 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.
- Subject is a non-smoker, 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 Screening.
Who cannot join
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- Active infection; a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to screening.
- Subjects with known clinically relevant immunological disorders.
- History of severe allergic or anaphylactic reactions.
- Known history or any symptom of clinically significant illness in the 6 months before the first 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.
Show all 21Show fewer
- 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 [millisecond], 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 prior to first dosing.
- 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 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.
- Concurrent participation or participation within 90 days prior to the initial study drug administration in a drug/device or biologic investigational research study.
- 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.
- Administration of an injectable drug within 30 days prior to the 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.
- Unsuitable vein for infusion and/or blood sampling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy Male Subjects
The study is a Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy Male Subjects
- Conditions
- Bioavailability Study
- Being tested
- ARGX-113
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGX-113Drug
intravenous or subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Scheme 1 Receives: Drug: ARGX-113 |
| 2 | Experimental | Scheme 2 Receives: Drug: ARGX-113 |
| 3 | Experimental | Scheme 3 Receives: Drug: ARGX-113 |
What is being measured
The primary outcome is the main question the study is designed to answer.
bioavailability of a s.c. ARGX-113 formulation
AUC0-inf
Measured: 1.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start11 Oct 2017
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bioavailability StudyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thierry Cousin, MD, Study director, argenx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334084
- Sponsor's protocol ID
- ARGX-113-1702
- Status last verified
- Aug 2020
- First submitted
- 23 Oct 2017
- Last updated
- 31 Aug 2020
- 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 39636455
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03334084
- Acronym / sponsor ID
- ARGX-113-1702
- Conditions
- Bioavailability Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 7 Nov 2017 (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.
The study is a Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy Male Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ARGX-113Scheme 1 |
| 2 | Experimental | Drug: ARGX-113Scheme 2 |
| 3 | Experimental | Drug: ARGX-113Scheme 3 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male, between 18-55 years of age.
- Body mass index (BMI) between 18-30 kg/m2.
- Willingness and ability to understand the purpose and risks of the study and provide signed and dated informed consent.
- 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.
- Subjects have to agree not to donate sperm until 90 days after the last administration of study drug.
Key exclusion criteria (21 listed)
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- Active infection; a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to screening.
- Subjects with known clinically relevant immunological disorders.
- History of severe allergic or anaphylactic reactions.
- Known history or any symptom of clinically significant illness in the 6 months before the first study drug administration.
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-113intravenous or subcutaneous administration | Drug | 1, 2, 3 |
Primary outcome
bioavailability of a s.c. ARGX-113 formulation
Time frame: 1.5 months
AUC0-inf
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 31 Aug 2020.
- 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.
- 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.
Thierry Cousin, MD study director
argenx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARGX-113 in people with Bioavailability Study, 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 8 inclusion and 21 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 31 Aug 2020. 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?
bioavailability of a s.c. ARGX-113 formulation (time frame: 1.5 months). 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 NCT03334084, which also lists 1 linked publication.
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 31 Aug 2020.