NCT06799416

A Study to Assess the Safety of ARGX-109 in Healthy Volunteers

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ARGX-109 Administered Subcutaneously in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study aims to assess the safety of ARGX-109 in healthy adults. Another aim is to measure the amount of ARGX-109 in the blood over time to learn how it moves through the body and acts in the body. Each participant will remain in the study for approximately 20 weeks.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
BIOLOGICAL	ARGX-109	administrations of ARGX-109
OTHER	Placebo	administrations of placebo comparator

Timeline

• Start date: 2025-01-14
• Primary completion: 2025-08-08
• Completion: 2025-08-08
• First posted: 2025-01-29
• Last updated: 2025-09-18

Locations

1 site across 1 country: Canada