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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
27
Single SC dose of etrolizumab at 105 milligrams (mg) on Day 1.
Participants self-administered etrolizumabSC injection using a prefilled auto-injector.
Unnamed facility
Cypress, California, United States
Unnamed facility
Dallas, Texas, United States
Percentage of Participants Experiencing Greater Than Mild Pain Immediately Following Injection at Time 0 Minute by 7-point Verbal Descriptive Scale (VDS-7)
Time frame: 0 minute (immediately following injection)
Percentage of Participants Experiencing Greater Than Mild Pain Over Time by VDS-7
Time frame: 5, 10, 20, 60 minutes and 4 hours following injection
Percentage of Participants in each VDS-7 over time
Time frame: 0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Mean Visual Analog Scale (VAS) over time
Time frame: 0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Mean change from baseline in VAS over time
Time frame: 0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Percentage of Participants With Injection-Site Reactions
Time frame: 5 minute to Day 85 (end of study)
Percentage of Participants With Probable Root-causes of AI Usage Errors
Time frame: Up to 4 hours following injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.