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OpenTrials
Completed

NCT Number: NCT06799416

A Study to Assess the Safety of ARGX-109 in Healthy Volunteers

This study aims to assess the safety of ARGX-109 in healthy adults. Another aim is to measure the amount of ARGX-109 in the blood over time to learn how it moves through the body and acts in the body. Each participant will remain in the study for approximately 20 weeks.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences - Montreal - Phase I unit

Mount Royal, Quebec, H3P 3P1, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • is aged 18 to 65 years, inclusive, when signing the ICF
  • has a body weight between 50 and 100 kg and a BMI between 18.5 and 30.0 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 results of the study or put the participant at undue risk

Treatment and study plan

ARGX-109

Biological

administrations of ARGX-109

Placebo

Other

administrations of placebo comparator

Primary outcomes

  1. Incidence of AEs, SAEs and AEs leading to discontinuation

    Time frame: up to 16 weeks

    AE: adverse event, SAE: serious adverse event

Secondary outcomes

  1. Cmax

    Time frame: up to 16 weeks

  2. Total IL-6 serum concentrations

    Time frame: up to 16 weeks

  3. Incidence of ADA against ARGX-109 in serum

    Time frame: up to 16 weeks

    ADA: anti-drug antibody

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ARGX-109 Administered Subcutaneously in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Sep 18, 2025

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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