Healthy VolunteerPhase 1NCT02629744
A Study to Evaluate Pain, Tolerability, Safety, and Usability of a Single Self-administered Etrolizumab by Auto-injector in Healthy Participants
A Phase 1 study testing Etrolizumab and Prefilled Auto-injector (Rotaject) in people with Healthy Volunteer, run by Genentech, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Etrolizumab and Prefilled Auto-injector (Rotaject)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2015to Jun 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Cypress, California, 90630
Study site
Dallas, Texas, 75247
About this study
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
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.
- Conditions
- Healthy Volunteer
- Being tested
- Etrolizumab, Prefilled Auto-injector (Rotaject)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtrolizumabDrug
Also called rhuMAB Beta7
Single SC dose of etrolizumab at 105 milligrams (mg) on Day 1.
Prefilled Auto-injector (Rotaject)Device
Participants self-administered etrolizumabSC injection using a prefilled auto-injector.
| Study group | Role | What they receive |
|---|---|---|
| Etrolizumab | Experimental | Participants will self-administer single SC dose of etrolizumab using prefilled auto-injector, into the abdomen or the anterior thigh. Receives: Drug: Etrolizumab; Device: Prefilled Auto-injector (Rotaject) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Greater Than Mild Pain Immediately Following Injection at Time 0 Minute by 7-point Verbal Descriptive Scale (VDS-7)
Measured: 0 minute (immediately following injection)
Secondary outcomes (6)
Percentage of Participants Experiencing Greater Than Mild Pain Over Time by VDS-7
Measured: 5, 10, 20, 60 minutes and 4 hours following injection
Percentage of Participants in each VDS-7 over time
Measured: 0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Mean Visual Analog Scale (VAS) over time
Measured: 0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Mean change from baseline in VAS over time
Measured: 0 (immediately following injection), 5, 10, 20, 60 minutes, and 4 hours following injection
Percentage of Participants With Injection-Site Reactions
Measured: 5 minute to Day 85 (end of study)
Percentage of Participants With Probable Root-causes of AI Usage Errors
Measured: Up to 4 hours following injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629744
- Sponsor's protocol ID
- GX29503
- Status last verified
- Nov 2016
- First submitted
- 10 Dec 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
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.
PubMed 33778928
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02629744
- Acronym / sponsor ID
- GX29503
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etrolizumab | Experimental | Drug: Etrolizumab, Device: Prefilled Auto-injector (Rotaject)Participants will self-administer single SC dose of etrolizumab using prefilled auto-injector, into the abdomen or the anterior thigh. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtrolizumabAlso: rhuMAB Beta7Single SC dose of etrolizumab at 105 milligrams (mg) on Day 1. | Drug | Etrolizumab |
| Prefilled Auto-injector (Rotaject)Participants self-administered etrolizumabSC injection using a prefilled auto-injector. | Device | Etrolizumab |
Primary outcome
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)
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 33778928Tyrrell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etrolizumab and Prefilled Auto-injector (Rotaject) in people with Healthy Volunteer, run by Genentech, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02629744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.