Healthy Volunteer
Conditions
Brief summary
This study aims to assess the safety of ARGX-109 in healthy adults. Another aim is to measure the amount of ARGX-109 in the blood over time to learn how it moves through the body and acts in the body. Each participant will remain in the study for approximately 20 weeks.
Interventions
BIOLOGICALARGX-109
administrations of ARGX-109
OTHERPlacebo
administrations of placebo comparator
Sponsors
argenx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs, SAEs and AEs leading to discontinuation | up to 16 weeks | AE: adverse event, SAE: serious adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | up to 16 weeks | — |
| Total IL-6 serum concentrations | up to 16 weeks | — |
| Incidence of ADA against ARGX-109 in serum | up to 16 weeks | ADA: anti-drug antibody |
Countries
Canada
Outcome results
None listed