ARGX-124 safety testing in healthy adults

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 tests whether ARGX-124 is safe and measures its blood levels and immune response in healthy adults aged 18–65.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: argenx (Industry-sponsored)
• Locations: 1 site (Montreal)
• Trial ID: NCT07377396 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Healthy adults aged 18–65 who are male or females of nonchildbearing potential, weigh 50–120 kg with BMI 18–30.5, have IgG ≥6.0 g/L, and have no immunosuppressive conditions or prior exposure to ARGX-124/ARGX-213/efgartigimod are ideal candidates.

Not a fit: People with immunosuppressive diseases, low IgG, females of childbearing potential, those with significant medical or psychiatric conditions, or those expecting direct therapeutic benefit should not expect personal medical benefit from participation.

Why it matters

Potential benefit: If successful, the results could identify a safe dose and dosing schedule that enable later studies in patients who may benefit from ARGX-124.

How similar studies have performed: Argenx has produced successful clinical results with related agents (for example efgartigimod), but ARGX-124 itself is a novel compound being tested in healthy volunteers for the first time.

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.

Where this trial is running

Montreal

• Altasciences — Montreal, Canada (Recruiting)

Study contacts

• Study coordinator: Sabine Coppieters, MD

Conditions Healthy Volunteers