ARGX-109 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an experimental drug called ARGX-109. Researchers aim to determine its safety and track its movement through the body by measuring blood levels over time. The study compares ARGX-109 to a placebo (a substance with no active drug) to assess any effects. Participants are healthy adults weighing between 50 and 100 kg with a BMI (body mass index) between 18.5 and 30. Generally healthy individuals fitting this profile may be suitable for the trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that ARGX-109 is likely to be safe for humans?
Research has shown that ARGX-109 has been tested in healthy adults to assess its safety. Early studies focus on the drug's behavior in the body. These studies are in the initial stages, with scientists primarily checking its safety for human use.
Researchers examine any side effects the drug might cause in these initial tests. The aim is to ensure ARGX-109 is well-tolerated. Reports from these studies suggest it is safe enough to continue testing, though specific details on side effects remain undisclosed. As this is an early study, scientists are still collecting safety information before advancing to more comprehensive testing.12345Why do researchers think this study treatment might be promising?
ARGX-109 is unique because it introduces a novel approach by utilizing an experimental drug designed to modulate the immune system. Unlike standard treatments that might focus on symptom management, ARGX-109 targets the underlying mechanism, potentially offering a more precise intervention. Researchers are excited about its potential to provide a new pathway for treatment, which could lead to better outcomes with fewer side effects for patients.
What evidence suggests that ARGX-109 might be an effective treatment for healthy subjects?
Research shows that ARGX-109 is in the early stages of testing. In this trial, participants will receive either ARGX-109 or a placebo. The focus is on assessing its safety and observing its behavior in the body of healthy individuals. Direct evidence of its effectiveness for any specific illness is not yet available. Researchers continue to study the treatment to determine its potential future applications. While there is interest in ARGX-109, solid proof of its effectiveness for treating any particular condition is still lacking. The ongoing studies are crucial for understanding its potential uses.13678
Are You a Good Fit for This Trial?
This trial is for healthy adults who want to help test the safety of a new medication called ARGX-109. Participants will be involved in the study for about 20 weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either ARGX-109 or placebo to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ARGX-109
Find a Clinic Near You
Who Is Running the Clinical Trial?
argenx
Lead Sponsor
Tim Van Hauwermeiren
argenx
Chief Executive Officer since 2008
B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management
Dr. Peter Ulrichts
argenx
Chief Medical Officer since 2023
MD from Maastricht University, PhD in Molecular Immunology from Maastricht University