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

argenx

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: ARGX-213; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06968338

ARGX-213-2401

Details and patient eligibility

About

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.

Enrollment: 72 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

ARGX-213

Experimental group

Description:

Participants receiving the experimental drug

Treatment:

Biological: ARGX-213

Placebo

Placebo Comparator group

Description:

Participants receiving placebo

Treatment:

Other: Placebo