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

NCT07377396 | Recruiting Phase 1 DMC

• 1 other identifier: ARGX-124-1-HV-1001
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  AE : adverse event ; SAE : serious adverse event.

  Up to 23 weeks

Secondary Outcomes (3)

• Maximum observed serum concentration (Cmax)

  Up to 23 weeks

• Percent change from baseline in total IgG levels in serum over time

  Up to 23 weeks

• Incidence of ADA against ARGX-124 in serum

  Up to 23 weeks

Study Arms (2)

ARGX-124

EXPERIMENTAL

Participants receiving the experimental drug

Biological: ARGX-124

Placebo

PLACEBO COMPARATOR

Participants receiving placebo

Other: Placebo

Interventions

ARGX-124 BIOLOGICAL

Administrations of ARGX-124

ARGX-124

Placebo OTHER

Administrations of placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• argenx: lead

Study Sites (1)

Altasciences

Montreal, H3P 3P1, Canada

RECRUITING

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 29, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)