ARGX-213 for Healthy Subjects

Overseen By Sabine Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: argenx

Disqualifiers: Medical, psychiatric conditions, ECG abnormality

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 12 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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

I am either a postmenopausal or surgically sterilized woman, or I am a man.

My weight is between 50 and 100 kg and my BMI is between 18 and 30.5.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple ascending doses of ARGX-213 or placebo

Approximately 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ARGX-213

Trial Overview The trial is testing ARGX-213, a new substance whose safety profile isn't yet known. Participants will either receive ARGX-213 or a placebo (a substance with no active drug). Researchers will monitor how ARGX-213 is processed in the body over time.

How Is the Trial Designed?

Group I: ARGX-213 Experimental Treatment 1 Intervention

Participants receiving the experimental drug

Group II: Placebo Placebo Group 1 Intervention

Participants receiving placebo

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

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