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

Healthy Volunteer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02629744
Study type Interventional
Source Genentech, Inc.
Contact
Status Completed
Phase Phase 1
Start date December 2015
Completion date June 2016
View Details
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