NCT02629744

A Study to Evaluate Pain, Tolerability, Safety, and Usability of a Single Self-administered Etrolizumab by Auto-injector in Healthy Participants

A PHASE 1, OPEN-LABEL, SINGLE-ARM STUDY IN HEALTHY SUBJECTS TO EVALUATE PAIN, TOLERABILITY, SAFETY, AND USABILITY OF A PREFILLED AUTOINJECTOR TO SELF-ADMINISTER ETROLIZUMAB SUBCUTANEOUSLY

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a multi-center, single-arm, open-label study in healthy participants to assess the pain, tolerability, injection leakage, safety, and usability of a single self-administered subcutaneous (SC) dose of etrolizumab. Some participants will receive "needle-experience" training using a needle and syringe on Days -7 and -5, and health care professionals (HCPs) will then assess the participant's suitability to self-inject with a prefilled auto-injector (AI). The remainder of participants will be "needle naïve" and will not have previously self-injected. Eligible" needle experienced" and" needle naive" participants will attend an AI training visit at the study site on Day -3 (three days prior to etrolizumab dosing on Day 1). Following training and simulated injections by the participant the HCP will determine if the participant is suitable to proceed to actual etrolizumab dosing. All eligible study participants will self administer a single dose of etrolizumab (by AI) on Day 1 and will be followed up to Day 85 following dosing. Pain, tolerability, safety and usuability will be assessed.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Etrolizumab	Single SC dose of etrolizumab at 105 milligrams (mg) on Day 1.
DEVICE	Prefilled Auto-injector (Rotaject)	Participants self-administered etrolizumabSC injection using a prefilled auto-injector.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-12-14
• Last updated: 2016-11-02

Locations

2 sites across 1 country: United States