This study will be conducted to compare the pharmacokinetic (PK) exposure after a single SC dose of anifrolumab administered using an AI with the PK exposure after a single subcutaneous (SC) dose of anifrolumab administered using APFS in healthy male and female volunteers.
This will be a multicenter, randomized, open-label, parallel group Phase 1 study. After meeting the eligibility criteria, all eligible participants will be randomized 1:1:1:1:1:1 to a device group (APFS or AI) for an anatomical injection site as defined in the protocol. Randomization will be stratified by protocol defined body weight categories and clinical unit. The study will comprise: * A Screening Period up to 28 days. * One treatment period during which eligible participants will be admitted to the Clinical Unit on Day -1 to reassess their eligibility. Participants who meet eligibility criteria will be randomized to receive a single subcutaneous (SC) dose of anifrolumab by either APFS or AI device on Day 1. Participants will be discharged on Day 3. * The participants will return to the center for Follow-up Visits on Days 6, 8, 12, 15, 22, 29, and 43. * A final Follow-up Visit on Day 57.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
180
Participants will receive SC doses anifrolumab via AI or APFS.
Autoinjector will be use to administer single SC dose of anifrolumab.
Accessorized Pre-filled syringe will be use to administer single SC dose of anifrolumab.
Research Site
Brooklyn, Maryland, United States
Research Site
Berlin, Germany
Research Site
Harrow, United Kingdom
Area under serum concentration-time curve from time zero extrapolated to infinity (AUCinf)
Evaluation of AUCinf following single SC administration of anifrolumab by AI is comparable to the AUCinf following single SC administration of anifrolumab using APFS will be done.
Time frame: Up to Day 57
Area under serum concentration-time curve from time zero to last quantifiable concentration (AUClast)
Evaluation of AUClast following single SC administration of anifrolumab by AI is comparable to the AUClast following single SC administration of anifrolumab using APFS will be done.
Time frame: Up to Day 57
Maximum observed serum (peak) drug concentration (Cmax)
Evaluation of Cmax following single SC administration of anifrolumab by AI is comparable to the Cmax following single SC administration of anifrolumab using APFS will be done.
Time frame: Up to Day 57
Time to reach peak or maximum observed concentration (tmax)
Evaluation of the tmax of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges.
Time frame: Day 1 to Day 57
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
Evaluation of the t1/2λz of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges will be done.
Time frame: Day 1 to Day 57
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT)
Evaluation of the MRT of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges will be done.
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Time frame: Day 1 to Day 57
Apparent total body clearance of drug after extravascular administration (CL/F)
Evaluation of the CL/F of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges will be done.
Time frame: Day 1 to Day 57
Apparent volume of distribution following extravascular administration (based on terminal phase) (Vz/F)
Evaluation of the Vz/F of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges will be done.
Time frame: Day 1 to Day 57
Time of last quantifiable concentration (tlast)
Evaluation of the tlast of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges will be done.
Time frame: Day 1 to Day 57
Number of participants with positive Anti-drug antibodies (ADA)
Evaluation of the immunogenicity of anifrolumab delivered by AI or APFS will be done.
Time frame: Day 1, 29 and 57
Number of participants with adverse events and serious adverse events
Evaluation of safety and tolerability of AI- vs APFS-administered anifrolumab will be done.
Time frame: Screening period (Day -28 to Day-2) through follow-up visit (Day 57) and evaluation of injection site reaction (Days 1 to 3)