Healthy VolunteersPhase 1NCT07377396
A Study to Assess the Safety of ARGX-124 in Healthy Volunteers
A Phase 1 study testing ARGX-124 in people with Healthy Volunteers, run by argenx at 1 site in Canada.
Trial summary
This study aims to assess the safety of ARGX-124 in healthy adults. Another aim is to measure the amount of ARGX-124 in the blood over time to learn how it acts and moves in the body and how the immune system responds to it. Participants will remain in the study for up to approximately 23 weeks. 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-124
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jan 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.
- Is a female of Nonchildbearing Potential (postmenopausal or surgically sterilized) or a male.
- Has a body weight between 50 and 120 kg and a BMI between 18 and 30.5 kg/m2, inclusive.
Who cannot join
- Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
- Has IgG levels <6.0 g/L at screening.
- Has a history of an immunosuppressive disease or an immunosuppressive condition at screening.
- Previously participated in an ARGX-124, ARGX-213, or efgartigimod clinical study and received at least 1 dose of the study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Altasciences
Montreal, H3P 3P1
Gaetano Morelli, MD, 857-350-4834, clinicaltrials@argenx.com
About this study
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-124 in Healthy Adult Participants
This study aims to assess the safety of ARGX-124 in healthy adults. Another aim is to measure the amount of ARGX-124 in the blood over time to learn how it acts and moves in the body and how the immune system responds to it. Participants will remain in the study for up to approximately 23 weeks.
- Conditions
- Healthy Volunteers
- Being tested
- ARGX-124, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGX-124Biological
Administrations of ARGX-124
PlaceboOther
Administrations of placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| ARGX-124 | Experimental | Participants receiving the experimental drug Receives: Biological: ARGX-124 |
| Placebo | Placebo comparator | Participants receiving placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs, SAEs and AEs leading to ARGX-124 discontinuation
AE : adverse event ; SAE : serious adverse event.
Measured: Up to 23 weeks
Secondary outcomes (3)
Maximum observed serum concentration (Cmax)
Measured: Up to 23 weeks
Percent change from baseline in total IgG levels in serum over time
IgG : immunoglobulin G
Measured: Up to 23 weeks
Incidence of ADA against ARGX-124 in serum
ADA : anti-drug antibodies
Measured: Up to 23 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start26 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377396
- Sponsor's protocol ID
- ARGX-124-1-HV-1001
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-124 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07377396
- Acronym / sponsor ID
- ARGX-124-1-HV-1001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 2026 (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.
This study aims to assess the safety of ARGX-124 in healthy adults. Another aim is to measure the amount of ARGX-124 in the blood over time to learn how it acts and moves in the body and how the immune system responds to it. Participants will remain in the study for up to approximately 23 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARGX-124 | Experimental | Biological: ARGX-124Participants receiving the experimental drug |
| Placebo | Placebo comparator | Other: PlaceboParticipants receiving placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.
- Is a female of Nonchildbearing Potential (postmenopausal or surgically sterilized) or a male.
- Has a body weight between 50 and 120 kg and a BMI between 18 and 30.5 kg/m2, inclusive.
Key exclusion criteria (4 listed)
- Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
- Has IgG levels <6.0 g/L at screening.
- Has a history of an immunosuppressive disease or an immunosuppressive condition at screening.
- Previously participated in an ARGX-124, ARGX-213, or efgartigimod clinical study and received at least 1 dose of the study drug.
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-124Administrations of ARGX-124 | Biological | ARGX-124 |
| PlaceboAdministrations of placebo comparator | Other | Placebo |
Primary outcome
Incidence of AEs, SAEs and AEs leading to ARGX-124 discontinuation
Time frame: Up to 23 weeks
AE : adverse event ; SAE : serious adverse event.
3 secondary outcomes
Maximum observed serum concentration (Cmax)
Time frame: Up to 23 weeks
Percent change from baseline in total IgG levels in serum over time
Time frame: Up to 23 weeks
Incidence of ADA against ARGX-124 in serum
Time frame: Up to 23 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
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-124 in people with Healthy Volunteers, run by argenx at 1 site in Canada.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs, SAEs and AEs leading to ARGX-124 discontinuation (time frame: Up to 23 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2026.