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OpenTrials
Completed

NCT Number: NCT06968338

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences

Montreal, QC H3P 3P1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARGX-213

Biological

Intravenous or subcutaneous administrations of ARGX-213

Placebo

Other

Intravenous or subcutaneous administrations of placebo

Primary outcomes

  1. Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation

    Time frame: Up to 17 weeks

Secondary outcomes

  1. ARGX-213 serum concentrations

    Time frame: Up to 17 weeks

  2. Percent change from baseline in total IgG concentrations in serum

    Time frame: Up to 17 weeks

  3. Incidence of antidrug antibodies against ARGX-213 in serum

    Time frame: Up to 17 weeks

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-213 in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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