NCT07377396 A Study to Assess the Safety of ARGX-124 in Healthy Volunteers
| NCT ID | NCT07377396 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | argenx |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2026-01-26 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 104 participants in total. It began in 2026-01-26 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07377396 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07377396 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07377396 currently recruiting?
Yes, NCT07377396 is actively recruiting participants. Contact the research team at clinicaltrials@argenx.com for enrollment information.
Where is the NCT07377396 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT07377396 clinical trial?
NCT07377396 is sponsored by argenx. The trial plans to enroll 104 participants.