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

argenx

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Biological: ARGX-124

Study type: Interventional

Funder types: Industry

Identifiers

NCT07377396

ARGX-124-1-HV-1001

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

ARGX-124

Experimental group

Description:

Participants receiving the experimental drug

Treatment:

Biological: ARGX-124

Placebo

Placebo Comparator group

Description:

Participants receiving placebo

Treatment:

Other: Placebo