Recruiting
Phase 1

ARGX-124

Sponsor:

argenx

Code:

NCT07377396

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

ARGX-124

Placebo

Study Details

Brief summary:

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.

Conditions

Healthy Volunteers

Study ID

NCT07377396

Start date

Jan 26, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ARGX-124

Participants receiving the experimental drug

placebo comparator: Placebo

Participants receiving placebo

Interventions

ARGX-124

Administrations of ARGX-124

Placebo

Administrations of placebo comparator

Primary outcome measure

  • Incidence of AEs, SAEs and AEs leading to ARGX-124 discontinuation [ Time Frame: Up to 23 weeks ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834clinicaltrials@argenx.com

Locations

Altasciences

Recruiting

Montreal, Canada, H3P 3P1

Contacts

Gaetano Morelli, MD

857-350-4834clinicaltrials@argenx.com

More Information

Sponsor

argenx

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by argenx on 2026-03-06.