Healthy VolunteersPhase 1NCT06968338
A Study to Assess the Safety of ARGX-213 in Healthy Volunteers
A Phase 1 study testing ARGX-213 in people with Healthy Volunteers, run by argenx at 1 site in Canada.
Trial summary
This study aims to assess the safety of ARGX-213 in healthy adults. Another aim is to measure the amount of ARGX-213 in the blood over time to learn how it moves through the body and acts in the body. The participants will remain in the study for approximately up to 21 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-213
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 11 Apr 2025to 20 Mar 2026
- 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
- Is at least the local legal age of consent for clinical studies and is aged 18 to 65 years, inclusive, when signing the ICF
- Is a female of nonchild bearing potential (either postmenopausal or surgically sterilized) or a male
- Has a body weight between 50 and 100 kg and a BMI between 18 and 30.5 kg/m^2, inclusive
Who cannot join
- Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- Has a clinically meaningful abnormality detected on ECG recording regarding either rhythm or conduction
Trial locations and contacts
1 site in 1 country.
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-213 in Healthy Adult Participants
This study aims to assess the safety of ARGX-213 in healthy adults. Another aim is to measure the amount of ARGX-213 in the blood over time to learn how it moves through the body and acts in the body. The participants will remain in the study for approximately up to 21 weeks.
- Conditions
- Healthy Volunteers
- Being tested
- ARGX-213, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGX-213Biological
Intravenous or subcutaneous administrations of ARGX-213
PlaceboOther
Intravenous or subcutaneous administrations of placebo
| Study group | Role | What they receive |
|---|---|---|
| ARGX-213 | Experimental | Participants receiving the experimental drug Receives: Biological: ARGX-213 |
| 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 adverse events, serious adverse events, and adverse events leading to the discontinuation
Measured: Up to 17 weeks
Secondary outcomes (3)
ARGX-213 serum concentrations
Measured: Up to 17 weeks
Percent change from baseline in total IgG concentrations in serum
Measured: Up to 17 weeks
Incidence of antidrug antibodies against ARGX-213 in serum
Measured: Up to 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start11 Apr 2025
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968338
- Sponsor's protocol ID
- ARGX-213-2401
- Status last verified
- Apr 2026
- First submitted
- 5 May 2025
- Last updated
- 23 Apr 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 23 Apr 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-213 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06968338
- Acronym / sponsor ID
- ARGX-213-2401
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 13 May 2025 (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-213 in healthy adults. Another aim is to measure the amount of ARGX-213 in the blood over time to learn how it moves through the body and acts in the body. The participants will remain in the study for approximately up to 21 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-213 | Experimental | Biological: ARGX-213Participants 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 for clinical studies and is aged 18 to 65 years, inclusive, when signing the ICF
- Is a female of nonchild bearing potential (either postmenopausal or surgically sterilized) or a male
- Has a body weight between 50 and 100 kg and a BMI between 18 and 30.5 kg/m^2, inclusive
Key exclusion criteria (2 listed)
- Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- Has a clinically meaningful abnormality detected on ECG recording regarding either rhythm or conduction
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-213Intravenous or subcutaneous administrations of ARGX-213 | Biological | ARGX-213 |
| PlaceboIntravenous or subcutaneous administrations of placebo | Other | Placebo |
Primary outcome
Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation
Time frame: Up to 17 weeks
3 secondary outcomes
ARGX-213 serum concentrations
Time frame: Up to 17 weeks
Percent change from baseline in total IgG concentrations in serum
Time frame: Up to 17 weeks
Incidence of antidrug antibodies against ARGX-213 in serum
Time frame: Up to 17 weeks
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 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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-213 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 2 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 Apr 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?
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?
Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation (time frame: Up to 17 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 23 Apr 2026.