Healthy Adult Participants, Healthy Volunteer
Conditions
Brief summary
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each. Each participant receives both efgartigimod PH20 SC AI and PFS treatments, in a different order. Participants will be in the study for up to approximately 9 weeks.
Interventions
BIOLOGICALEfgartigimod PH20 SC via PFS
Subcutaneous injection of empasiprubart via Prefilled syringe (PFS)
BIOLOGICALEfgartigimod PH20 SC via AI
Subcutaneous injection of empasiprubart via Autoinjector (AI)
Sponsors
argenx
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Is at least the local legal age of consent and aged 18 to 55 years, inclusive, when signing the ICF. * Has a body weight between 50 and 100 kg and a BMI between 18 and 30 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 study results or put the participant at undue risk. * Has received any medications, including nonprescription and prescription medications, within 2 weeks before the first IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed. * Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary PK parameter: Cmax | Up to 9 weeks | Cmax = maximum observed concentration |
| Primary PK parameter: AUC0-inf | Up to 9 weeks | AUC0-inf = area under the curve from time 0 to infinity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary PK parameter: AUC0-t | Up to 9 weeks | AUC0-t = area under the curve from time 0 to the last measurable time point |
| Secondary PK parameter: AUC0-168h | Up to 9 weeks | AUC0-168h = area under the curve from time 0 to 168 hours |
| Secondary PK parameter: CL/F | Up to 9 weeks | CL/F = apparent clearance from plasma after extravascular administration |
| Secondary PK parameter: Vz/F | Up to 9 weeks | Vz/F = apparent volume of distribution at steady state after extravascular administration |
| Secondary PK parameter: Tmax | Up to 9 weeks | Tmax = time to Cmax |
| Secondary PK parameter: t½ | Up to 9 weeks | t½ = half-life |
| Incidence of AEs, SAEs, and AEs leading to efgartigimod discontinuation | Up to 9 weeks | AE = adverse event ; SAE = serious adverse event |
Countries
Canada
Contacts
CONTACTSabine Coppieters, MD
Outcome results
None listed