Etrolizumab
DrugSingle SC dose of etrolizumab at 105 milligrams (mg) on Day 1.
Other names: rhuMAB Beta7
NCT Number: NCT02629744
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Cypress, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single SC dose of etrolizumab at 105 milligrams (mg) on Day 1.
Other names: rhuMAB Beta7
Participants self-administered etrolizumabSC injection using a prefilled auto-injector.
Time frame: 0 minute (immediately following injection)
Time frame: 5, 10, 20, 60 minutes and 4 hours following injection
Time frame: 0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Time frame: 0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Time frame: 0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Time frame: 5 minute to Day 85 (end of study)
Time frame: Up to 4 hours following injection
Genentech, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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