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

NCT ID: NCT06968338

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-11

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ARGX-213

Participants receiving the experimental drug

Group Type EXPERIMENTAL

ARGX-213

Intervention Type BIOLOGICAL

Intravenous or subcutaneous administrations of ARGX-213

Placebo

Participants receiving placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Intravenous or subcutaneous administrations of placebo

Interventions

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ARGX-213

Intravenous or subcutaneous administrations of ARGX-213

Intervention Type BIOLOGICAL

Placebo

Intravenous or subcutaneous administrations of placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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argenx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Altasciences

Montreal, , Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sabine Coppieters, MD

Role: CONTACT

857-350-4834

Facility Contacts

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Gaetano Morelli, MD

Role: primary

857-350-4834

Other Identifiers

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ARGX-213-2401

Identifier Type: -

Identifier Source: org_study_id

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