Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07377396

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.
  • Is a female of Nonchildbearing Potential (postmenopausal or surgically sterilized) or a male.
  • Has a body weight between 50 and 120 kg and a BMI between 18 and 30.5 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 study results or put the participant at undue risk.
  • Has IgG levels <6.0 g/L at screening.
  • Has a history of an immunosuppressive disease or an immunosuppressive condition at screening.
  • Previously participated in an ARGX-124, ARGX-213, or efgartigimod clinical study and received at least 1 dose of the study drug.

Treatment and study plan

ARGX-124

Biological

Administrations of ARGX-124

Placebo

Other

Administrations of placebo comparator

Primary outcomes

  1. Incidence of AEs, SAEs and AEs leading to ARGX-124 discontinuation

    Time frame: Up to 23 weeks

    AE : adverse event ; SAE : serious adverse event.

Secondary outcomes

  1. Maximum observed serum concentration (Cmax)

    Time frame: Up to 23 weeks

  2. Percent change from baseline in total IgG levels in serum over time

    Time frame: Up to 23 weeks

    IgG : immunoglobulin G

  3. Incidence of ADA against ARGX-124 in serum

    Time frame: Up to 23 weeks

    ADA : anti-drug antibodies

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.