ARGX-213 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new drug, ARGX-213, in healthy adults. Researchers aim to understand how the drug moves and behaves in the body by measuring its blood levels over time. Participants will receive either ARGX-213 or a placebo (a substance with no active drug) for comparison. The trial seeks healthy adults who are non-pregnant females or males, weigh between 50 and 100 kg, and have a BMI between 18 and 30.5. As a Phase 1 trial, this research focuses on understanding how ARGX-213 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop 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 trial organizers or your doctor.
Is there any evidence suggesting that ARGX-213 is likely to be safe for humans?
Research shows that ARGX-213 is being tested for safety in healthy adults. As it is in the early stages of testing, detailed safety information is not yet available. Early trials focus on ensuring a treatment's safety for humans, so ARGX-213 is closely monitored for any side effects. Participants in this study help researchers learn how the body reacts to the treatment and whether it is well-tolerated. Since safety details are still being gathered, ongoing monitoring remains crucial.12345
Why do researchers think this study treatment might be promising?
ARGX-213 is unique because it represents a novel approach to treatment, potentially offering advantages over existing therapies. Unlike current standard treatments that may work through different pathways, ARGX-213 targets a specific mechanism that researchers believe could improve efficacy and safety. This innovation might result in better outcomes with fewer side effects, making it a promising option for the future. Researchers are particularly excited about the potential of ARGX-213 to offer a new level of precision in treatment, marking a step forward in therapeutic development.
What evidence suggests that ARGX-213 might be an effective treatment for healthy adults?
Currently, specific information on the effectiveness of ARGX-213 for treating any conditions is unavailable. In this trial, participants will receive either ARGX-213 or a placebo at random. Researchers are testing it in healthy adults to assess its safety and understand its behavior in the body. This means its potential to help with any diseases remains unknown. ARGX-213 is in the early stages of research, with the main focus on its safety and pharmacokinetics. As research progresses, more may be learned about its potential uses and effectiveness. For now, the priority is to gather safety data and understand its action in the human body.13467
Are You a Good Fit for This Trial?
This clinical trial is open to healthy adults who meet specific health criteria. The exact inclusion and exclusion details aren't provided, but typically participants must have no significant medical conditions and be willing to follow the study procedures for up to 21 weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single and multiple ascending doses of ARGX-213 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ARGX-213
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