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

Phase 1

Recruiting

• Conditions: Healthy Volunteer
• Interventions: Other: Placebo; Biological: ARGX-109

• Registration Number: NCT06799416
• Lead Sponsor: argenx

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-14
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• is aged 18 to 65 years, inclusive, when signing the ICF
• has a body weight between 50 and 100 kg and a BMI between 18.5 and 30.0 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 results of the study or put the participant at undue risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants receiving placebo
ARGX-109	ARGX-109	Participants receiving the experimental drug

Primary Outcome Measures

Name	Time	Method
Incidence of AEs, SAEs and AEs leading to discontinuation	up to 16 weeks	AE: adverse event, SAE: serious adverse event

Secondary Outcome Measures

Name	Time	Method
Cmax	up to 16 weeks
Total IL-6 serum concentrations	up to 16 weeks
Incidence of ADA against ARGX-109 in serum	up to 16 weeks	ADA: anti-drug antibody

Trial Locations

Locations (1)

Altasciences - Montreal - Phase I unit; 🇨🇦 Mount-Royal, Quebec, Canada