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

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Biological: ARGX-213; Other: Placebo

• Registration Number: NCT06968338
• Lead Sponsor: argenx

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-11
• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-01-06
• Study Completion: 2026-01-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Is at least the local legal age of consent for clinical studies and is aged 18 to 65 years, inclusive, when signing the ICF
• Is a female of nonchild bearing potential (either postmenopausal or surgically sterilized) or a male
• Has a body weight between 50 and 100 kg and a BMI between 18 and 30.5 kg/m^2, 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
• Has a clinically meaningful abnormality detected on ECG recording regarding either rhythm or conduction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARGX-213	ARGX-213	Participants receiving the experimental drug
Placebo	Placebo	Participants receiving placebo

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation	Up to 17 weeks

Secondary Outcome Measures

Name	Time	Method
ARGX-213 serum concentrations	Up to 17 weeks
Percent change from baseline in total IgG concentrations in serum	Up to 17 weeks
Incidence of antidrug antibodies against ARGX-213 in serum	Up to 17 weeks

Trial Locations

Locations (1)

Altasciences; 🇨🇦 Montréal, Canada