This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD (reference device) in healthy participants. The study will comprise a pilot cohort (Part 1) to estimate the geometric mean ratio (GMR) and variability of the maximum observed concentration (Cmax) and area under the concentration-time curve (AUC) to confirm or determine the sample size for the pivotal cohort (Part 2). The pivotal cohort will demonstrate exposure comparability of Cmax, AUC from Hour 0 to the last measurable concentration (AUClast), and AUC from Hour 0 to extrapolated infinite time (AUC0-inf), values for a single dose of etrolizumab administered subcutaneously either by the AI or the PFS-NSD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
180
Etrolizumab will be administered at a dose of 105 milligrams (mg).
The pre-filled AI will be used to administer etrolizumab.
The PFS-NSD will be used to administer etrolizumab.
Covance Research Unit - Daytona
Daytona Beach, Florida, United States
Covance Clinical Research Unit Inc.; Covance Gfi Research
Evansville, Indiana, United States
Covance Research Unit - Dallas
Dallas, Texas, United States
Covance Clinical Research Unit, Inc
Madison, Wisconsin, United States
Part 1: Cmax of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Part 1: AUClast of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Part 1: AUC0-inf of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Part 1: Ratio of AUClast to AUC0-inf (AUCR) of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Part 2: Cmax of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Part 2: AUClast of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Part 2: AUC0-inf of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Part 1: Time to Maximum Observed Concentration (tmax) of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Part 2: tmax of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Part 1: Apparent Terminal Elimination Half-Life (t1/2) of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Part 2: t1/2 of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Part 2: AUCR of Etrolizumab
Time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)
Percentage of Participants With Adverse Events
Time frame: Part 1 and 2: Baseline up to Day 71
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Etrolizumab
Time frame: Part 1 and 2: Baseline up to Day 71
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