Assessing the safety of ARGX-213 in healthy adults
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-213 in Healthy Adult Participants
PHASE1 · argenx · NCT06968338
This study is testing the safety of a new drug called ARGX-213 in healthy adults to see how it affects them over 21 weeks.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | argenx (industry) |
| Locations | 1 site (Montréal) |
| Trial ID | NCT06968338 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of a drug called ARGX-213 in healthy volunteers. Participants will receive either the drug or a placebo and will be monitored for safety and how the drug is processed in the body over a period of up to 21 weeks. The study aims to gather important data on the drug's effects and its pharmacokinetics. Healthy adults aged 18 to 65 who meet specific criteria will be eligible to participate.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 who meet specific weight and BMI criteria.
Not a fit: Patients with significant medical or psychiatric conditions or those with abnormal ECG results may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data for ARGX-213, potentially leading to its use in treating various conditions.
How similar studies have performed: Similar studies assessing the safety of new drugs in healthy volunteers have shown success in providing critical safety data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Is at least the local legal age of consent for clinical studies and is aged 18 to 65 years, inclusive, when signing the ICF * Is a female of nonchild bearing potential (either postmenopausal or surgically sterilized) or a male * Has a body weight between 50 and 100 kg and a BMI between 18 and 30.5 kg/m\^2, 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 * Has a clinically meaningful abnormality detected on ECG recording regarding either rhythm or conduction
Where this trial is running
Montréal
- Altasciences — Montréal, 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.
Conditions: Healthy Volunteers