An open-label, single dose Pharmacokinetic (PK) comparability study to demonstrate comparable drug exposure following Subcutaneous benralizumab administration by using accessorized pre-filled syringe (APFS) or autoinjector (AI) devices.
A study of descriptive comparison of benralizumab PK by weight and injection site. This study will be a multicenter, randomized, open-label, parallel group Phase 1 study designed to compare benralizumab PK exposure in healthy subjects following single subcutaneous (SC) administration of fixed 30 mg dose of benralizumab by using APFS and single-use AI. Eligible subjects will be healthy subjects aged 18 to 55 years, with a body weight of 55 to 100 kg and a body mass index of 18 to 29.9 kg/m2 . A total of 180 subjects will be randomized. Randomization will be stratified by weight group (55 to 69.9 kg, 70 to 84.9 kg and 85 to 100 kg), and within each of the 3 weight groups, subjects will be randomized 1:1:1:1:1:1 to 1 of the 6 combinations of treatment (APFS or AI) with injection site (upper arm, abdomen or thigh), presented in Table 1. This study will be performed at 2 study centers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.
A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.
Research Site
Berlin, Germany
Research Site
Harrow, Germany
Area Under the Concentration-time Curve From Zero to Infinity (AUCinf)
To compare the AUCinf following single SC administration of Benralizumab by using APFS or AI devices
Time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
To compare the AUClast following single SC administration of Benralizumab by using APFS or AI devices
Time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Maximum Observed Concentration (Cmax)
To compare the Cmax following single SC administration of Benralizumab by using APFS or AI devices
Time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Time When Maximum Concentration is Observed (Tmax)
To evaluate the Tmax of Benralizumab administered to various injection sites and in subjects with different body weight ranges
Time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Terminal Half-life (t½)
To evaluate the t½ of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
Time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Apparent Extravascular Clearance (CL/F)
To evaluate the CL/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
Time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
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Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
To evaluate the Vz/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
Time frame: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Number of Participants With Adverse Events
To evaluate safety and tolerability of Benralizumab
Time frame: At predose and 2 h postdose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Antidrug Antibody (ADA) Status
To evaluate the immunogenicity of Benralizumab
Time frame: At predose (Day 1), Days 29 and 57