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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Etrolizumab; Device: Prefilled Auto-injector (Rotaject)

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
  • Texas
    • Dallas, Texas, United States, 75247

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or females, between 18 and 65 years of age, inclusive
• Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive
• In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiograms (ECGs), and vital signs
• Females will be non-pregnant, non-lactating, and either postmenopausal (at least 1 year of non therapy induced amenorrhea), surgically sterile (absence of ovaries and/or uterus) for at least 90 days, or agree to remain abstinent or use a highly effective method of contraception for at least 24 weeks after the single dose of study drug
• Males will either be sterile or agree to remain abstinent or use a highly effective method of contraception for at least 24 weeks after the single dose of study drug. Male participants will refrain from sperm donation from Check-in (Day -1) until 24 weeks following study drug administration

Exclusion Criteria:

• Participation in any other investigational study drug or biological agent trial (including investigational vaccines) in which receipt of an investigational study drug occurred within 30 days or 5 half-lives or receipt of a biologic agent occurred within 90 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1) and during the entire study
• Any prior treatment with etrolizumab or other anti integrin agents (including natalizumab, vedolizumab, and efalizumab)
• Any prior exposure to immunosuppressive agents (e.g., methotrexate, azathoprine, mercaptopurine)
• Use of IV steroids within 30 days prior to Screening;
• Chronic nonsteroidal anti inflammatory drug (NSAID)
• Use of any prescription medications/products within 14 days prior to Check in (Day -1)
• History of demyelinating disease
• Neurological conditions or diseases
• History of cancer
• History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1)
• History of active or latent tuberculosis (TB), regardless of treatment history
• History of recurrent opportunistic infections, severe disseminated viral infections (e.g., herpes), or any serious opportunistic infection within the last 6 months
• Positive for human immunodeficiency virus (HIV) antibody
• Any current or recent signs or symptoms of infection
• Inability to sense pain (e.g., peripheral neuropathy) and have a history of or have been diagnosed with a chronic pain syndrome

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Etrolizumab; Participants will self-administer single SC dose of etrolizumab using prefilled auto-injector, into the abdomen or the anterior thigh.	Drug: Etrolizumab; Single SC dose of etrolizumab at 105 milligrams (mg) on Day 1.; Other Names: rhuMAB Beta7; Device: Prefilled Auto-injector (Rotaject); Participants self-administered etrolizumabSC injection using a prefilled auto-injector.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Experiencing Greater Than Mild Pain Immediately Following Injection at Time 0 Minute by 7-point Verbal Descriptive Scale (VDS-7)	0 minute (immediately following injection)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Experiencing Greater Than Mild Pain Over Time by VDS-7	5, 10, 20, 60 minutes and 4 hours following injection
Percentage of Participants in each VDS-7 over time	0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Mean Visual Analog Scale (VAS) over time	0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Mean change from baseline in VAS over time	0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Percentage of Participants With Injection-Site Reactions	5 minute to Day 85 (end of study)
Percentage of Participants With Probable Root-causes of AI Usage Errors	Up to 4 hours following injection

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Publications and helpful links

General Publications

• Tyrrell H, Ravanello R, Pulley J, Tang MT, Zhang W, Abouhossein M, Tole S. An Open-Label Tolerability and Actual-Use Human Factors Study of Etrolizumab Autoinjector in Healthy Volunteers. Adv Ther. 2021 May;38(5):2406-2417. doi: 10.1007/s12325-021-01651-8. Epub 2021 Mar 29.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 10, 2015
• First Posted (Estimate): December 14, 2015

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Gastrointestinal Agents; Etrolizumab
• Other Study ID Numbers: GX29503