NCT02996019

A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)

A Randomized, Open-Label, 2-Part, 2-Arm, Parallel-Group, Single-Dose, Multi-Center Study in Healthy Subjects to Investigate the Comparability of Pharmacokinetics of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device or an Auto-Injector

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Etrolizumab	Etrolizumab will be administered at a dose of 105 milligrams (mg).
DEVICE	Auto-Injector (AI)	The pre-filled AI will be used to administer etrolizumab.
DEVICE	Prefilled Syringe With Needle Safety Device (PFS-NSD)	The PFS-NSD will be used to administer etrolizumab.

Timeline

• Start date: 2016-12-07
• Primary completion: 2018-04-09
• Completion: 2018-04-09
• First posted: 2016-12-19
• Last updated: 2018-12-03

Locations

4 sites across 1 country: United States