Healthy Volunteers
Conditions
Brief summary
This study aims to see how the body reacts to empasiprubart, administered using an autoinjector (AI). The study will also look at other effects of empasiprubart, how it works in the body, and if it is safe. The study consists of 2 parts: parts A and B. In part A, eligible participants will be randomized to receive empasiprubart SC AI via abdomen, empasiprubart SC AI via thigh, or empasiprubart IV (intravenously). In part B, eligible participants will be randomized to receive empasiprubart SC AI via abdomen or empasiprubart IV. Participants from part A will be in the study for approximately up to 37 weeks . Participants from part B will be in the study for up to approximately 43 weeks.
Interventions
BIOLOGICALempasiprubart SC AI
Subcutaneous injection of empasiprubart via Autoinjector (AI).
BIOLOGICALempasiprubart IV
Intravenous infusion of empasiprubart
Sponsors
argenx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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 and aged 18 to 65 years, inclusive, when signing the ICF. * Has a body weight between 50 and 120 kg and a BMI between 18 and 35 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. * Clinical diagnosis of SLE. For participants with an antinuclear antibody titer of ≥1:80 and a positive anti-double-stranded DNA and/or positive anti-Smith result at screening, an SLE diagnosis must be ruled out before the first IMP administration. * Previously participated in an empasiprubart clinical study and received at least 1 dose of IMP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV | Up to 33 weeks | aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous |
| aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV | Up to 33 weeks | aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous |
| Ctrough at week 8 | Up to 8 weeks | Ctrough = trough concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| empasiprubart Cmax | Up to 33 weeks | Cmax = maximum observed concentration |
| AUCw4-8 over time | Up to 39 weeks | AUCw4-8 = area under the concentration-time curve from week 4 to week 8 |
| Cavg over time | Up to 39 weeks | Cavg = average concentration |
| Ctrough over time | Up to 39 weeks | Ctrough = trough concentration |
| Percentage change from baseline in free C2 and total C2 over time | Up to 33 weeks (Part A) + up to 39 weeks (Part B) | C2 = complement component 2 |
| Incidence of ADA against empasiprubart in serum | Up to 33 weeks (Part A) + up to 39 weeks (Part B) | ADA = antidrug antibody(ies) |
| Incidence of AEs, SAEs, and AEs leading to empasiprubart discontinuation | Up to 33 weeks (Part A) + up to 39 weeks (Part B) | AE=adverse event; SAE=serious adverse event |
Countries
Canada
Contacts
CONTACTSabine Coppieters, MD
Outcome results
None listed