ARGX-124 safety testing in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial gives ARGX-124 or placebo to healthy volunteers to measure safety, drug concentrations in blood over time, and immune responses. Participants will undergo screening, receive study infusions, and have repeated blood draws and safety monitoring. Eligible volunteers are males or females of nonchildbearing potential aged 18–65 with specified weight and BMI ranges, and people with low IgG or immunosuppressive conditions are excluded. Total participation lasts up to about 23 weeks with in-clinic monitoring and scheduled follow-up visits.

Why it matters

Who can join: the full rules

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.

Where it's running

• Altasciences
  Montreal, Canada Recruiting

Study contacts

• Study coordinator: Sabine Coppieters, MD
• Email: clinicaltrials@argenx.com
• Phone: 857-350-4834

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.