The purpose of this study is to compare the pharmacokinetic (PK) exposures of a single subcutaneous (SC) dose of tozorakimab administered using AI or APFS in healthy participants.
This is a multiple center, randomized, open-label, parallel group, Phase 1 study. Participants will be randomized 1:1:1:1:1:1 to one of the 6 combinations of the devices (APFS or AI devices) and one of three injection sites (abdomen, thigh, or upper arm.). The study includes: * A screening period of up to 28 days. * A treatment period (up to 9 days). * A follow-up period till 85 days. * A final follow-up visit on Day 113 (Week 16).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
254
Tozorakimab will be administered as a single SC dose using an AI or APFS device on Day 1.
AI device will be used to administer single SC dose of tozorakimab on Day 1.
APFS device will be used to administer single SC dose of tozorakimab on Day 1.
Research Site
Glendale, California, United States
Research Site
Baltimore, Maryland, United States
Research Site
Berlin, Germany
Research Site
Harrow, United Kingdom
Area under concentration-time curve from time 0 to infinity (AUCinf) of tozorakimab
To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
Time frame: From Day 1 to Day 113
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of tozorakimab
To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
Time frame: From Day 1 to Day 113
Maximum observed drug concentration (Cmax) of tozorakimab
To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
Time frame: From Day 1 to Day 113
Time to reach maximum observed concentration (Tmax)
To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
Time frame: From Day 1 to Day 113
Terminal elimination half-life (t1/2λz)
To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
Time frame: From Day 1 to Day 113
Terminal rate constant (λz)
To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
Time frame: From Day 1 to Day 113
Apparent total body clearance (CL/F)
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To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
Time frame: From Day 1 to Day 113
Apparent volume of distribution based on the terminal phase (Vz/F)
To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
Time frame: From Day 1 to Day 113
Number of participants with adverse events (AEs)
To assess the safety and tolerability following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
Time frame: From screening (Day -28 to -2) to follow up (Day 113)
Number of participants with positive anti-drug antibodies (ADA)
To evaluate the immunogenicity following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
Time frame: From Day 1 to Day 113