Healthy Volunteers
Conditions
Brief summary
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.
Interventions
BIOLOGICALARGX-213
Intravenous or subcutaneous administrations of ARGX-213
OTHERPlacebo
Intravenous or subcutaneous administrations of placebo
Sponsors
argenx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation | Up to 17 weeks |
Secondary
| Measure | Time frame |
|---|---|
| ARGX-213 serum concentrations | Up to 17 weeks |
| Percent change from baseline in total IgG concentrations in serum | Up to 17 weeks |
| Incidence of antidrug antibodies against ARGX-213 in serum | Up to 17 weeks |
Countries
Canada
Outcome results
None listed