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OpenTrials
Completed

NCT Number: NCT02629744

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

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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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cypress, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etrolizumab

Drug

Single SC dose of etrolizumab at 105 milligrams (mg) on Day 1.

Other names: rhuMAB Beta7

Prefilled Auto-injector (Rotaject)

Device

Participants self-administered etrolizumabSC injection using a prefilled auto-injector.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. Mean Visual Analog Scale (VAS) over time

    Time frame: 0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection

  4. Mean change from baseline in VAS over time

    Time frame: 0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection

  5. Percentage of Participants With Injection-Site Reactions

    Time frame: 5 minute to Day 85 (end of study)

  6. Percentage of Participants With Probable Root-causes of AI Usage Errors

    Time frame: Up to 4 hours following injection

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 14, 2015
Registry last updated
Nov 2, 2016

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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