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

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-14

Study Completion Date

2025-08-08

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ARGX-109

Participants receiving the experimental drug

Group Type EXPERIMENTAL

ARGX-109

Intervention Type BIOLOGICAL

administrations of ARGX-109

Placebo

Participants receiving placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

administrations of placebo comparator

Interventions

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ARGX-109

administrations of ARGX-109

Intervention Type BIOLOGICAL

Placebo

administrations of placebo comparator

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes