Assessing the safety of ARGX-109 in healthy adults
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ARGX-109 Administered Subcutaneously in Healthy Adult Participants
This study is testing the safety of a new drug called ARGX-109 in healthy adults aged 18 to 65 to see how it affects them over about 20 weeks.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | argenx Industry-sponsored |
| Locations | 1 site (Mount-Royal, Quebec) |
| Trial ID | NCT06799416 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of ARGX-109 in healthy volunteers aged 18 to 65. Participants will receive either the drug or a placebo and will be monitored for approximately 20 weeks. The study also aims to measure how ARGX-109 is absorbed and processed in the body over time. The findings will help determine the safety profile of this intervention.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 with a body weight between 50 and 100 kg and a BMI between 18.5 and 30.0.
Not a fit: Patients with significant medical or psychiatric conditions that could affect study results or pose risks will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data for ARGX-109, informing future treatments for various conditions.
How similar studies have performed: Other studies assessing the safety of new drugs in healthy volunteers have shown success, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mount-Royal, Quebec
- Altasciences - Montreal - Phase I unit — Mount-Royal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Sabine Coppieters, MD
- Email: clinicaltrials@argenx.com
- Phone: 857-350-4834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.