NCT06968338

A Study to Assess the Safety of ARGX-213 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-213 in Healthy Adult Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	ARGX-213	Intravenous or subcutaneous administrations of ARGX-213
OTHER	Placebo	Intravenous or subcutaneous administrations of placebo

Timeline

• Start date: 2025-04-11
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2025-05-13
• Last updated: 2025-11-21

Locations

1 site across 1 country: Canada