NCT07377396

A Study to Assess the Safety of ARGX-124 in Healthy Volunteers

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	ARGX-124	Administrations of ARGX-124
OTHER	Placebo	Administrations of placebo comparator

Timeline

• Start date: 2026-01-26
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-01-29
• Last updated: 2026-03-06

Locations

1 site across 1 country: Canada