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

Last updated: May 5, 2025
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

Placebo

ARGX-213

Clinical Study ID

NCT06968338
ARGX-213-2401
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is at least the local legal age of consent for clinical studies and is aged 18 to 65years, inclusive, when signing the ICF

  • Is a female of nonchild bearing potential (either postmenopausal or surgicallysterilized) 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

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 theparticipant at undue risk

  • Has a clinically meaningful abnormality detected on ECG recording regarding eitherrhythm or conduction

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
April 11, 2025
Estimated Completion Date:
January 06, 2026

Connect with a study center

  • Altasciences

    Montréal, QC H3P 3P1
    Canada

    Active - Recruiting

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