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Healthy VolunteersPhase 1NCT02996019

A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)

A Phase 1 study testing Etrolizumab, Auto-Injector (AI) and Prefilled Syringe With Needle Safety Device (PFS-NSD) in people with Healthy Volunteers, run by Genentech, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD (reference device) in healthy participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Etrolizumab, Auto-Injector (AI) and Prefilled Syringe With Needle Safety Device (PFS-NSD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
4 sitesUnited States
Study dates
7 Dec 2016to 9 Apr 2018
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Within the body weight range of 60 to 100 kilograms, inclusive (for the pivotal cohort [Part 2] only)
  • Within body mass index (BMI) range 18.0 to 30.0 kilograms per square meter (kg/m^2), inclusive
  • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs
  • Females will be non-pregnant, non-lactating, and either postmenopausal (at least 12 months of non-therapy-induced amenorrhea)/surgically sterile (e.g., tubal ligation, hysterectomy) for at least 90 days prior to enrolment, or agree to remain abstinent/use a highly effective method of contraception for at least 24 weeks after study drug administration
  • Males will either be sterile or agree to remain abstinent/use a highly effective method of contraception for at least 24 weeks after study drug administration. Male participants will refrain from sperm donation from Check-in (Day -1) until 24 weeks following study drug administration

Who cannot join

  • Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
  • Any prior treatment with anti-mucosal addressin cell adhesion molecule 1 (anti-MAdCAM-1) agents
  • Any prior treatment with rituximab
  • Received intravenous corticosteroids within 30 days prior to Screening
  • Use of agents that deplete B or T cells (e.g., alemtuzumab, rituximab, or visilizumab) within 12 months prior to randomization
  • Any prior immunosuppressive agents (including cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil)
Show all 21Show fewer
  • Chronic nonsteroidal anti-inflammatory drug (NSAID) use
  • 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 less than (<) 1 year prior to Screening
  • History of active or latent tuberculosis (TB), regardless of treatment history
  • History of recurrent opportunistic infections and/or history of severe disseminated viral infections
  • Positive for human immunodeficiency virus (HIV) antibody
  • Any current or recent signs or symptoms of infection
  • Pregnant or lactating
  • Hospitalized within 4 weeks prior to and during Screening
  • History of organ transplant
  • Presence of skin rash at Screening or history of other skin disorders
  • Tattoos, scars, chronic rashes, or sunburn in the area of the designated injection site

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Covance Research Unit - Dallas

    Dallas, Texas, 75247

  • Covance Research Unit - Daytona

    Daytona Beach, Florida, 32117

  • Covance Clinical Research Unit Inc.; Covance Gfi Research

    Evansville, Indiana, 47710

  • Covance Clinical Research Unit, Inc

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Randomized, Open-Label, 2-Part, 2-Arm, Parallel-Group, Single-Dose, Multi-Center Study in Healthy Subjects to Investigate the Comparability of Pharmacokinetics of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device or an Auto-Injector

This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD (reference device) in healthy participants. The study will comprise a pilot cohort (Part 1) to estimate the geometric mean ratio (GMR) and variability of the maximum observed concentration (Cmax) and area under the concentration-time curve (AUC) to confirm or determine the sample size for the pivotal cohort (Part 2). The pivotal cohort will demonstrate exposure comparability of Cmax, AUC from Hour 0 to the last measurable concentration (AUClast), and AUC from Hour 0 to extrapolated infinite time (AUC0-inf), values for a single dose of etrolizumab administered subcutaneously either by the AI or the PFS-NSD.

Being tested
Etrolizumab, Auto-Injector (AI), Prefilled Syringe With Needle Safety Device (PFS-NSD)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtrolizumabDrug

    Also called RO5490261

    Etrolizumab will be administered at a dose of 105 milligrams (mg).

  • Auto-Injector (AI)Device

    The pre-filled AI will be used to administer etrolizumab.

  • Prefilled Syringe With Needle Safety Device (PFS-NSD)Device

    The PFS-NSD will be used to administer etrolizumab.

Study groups in NCT02996019
Study groupRoleWhat they receive
Part 1: Etrolizumab AIExperimentalParticipants will receive a single dose of etrolizumab via subcutaneous (SC) injection using the AI on Day 1.
Receives: Drug: Etrolizumab; Device: Auto-Injector (AI)
Part 1: Etrolizumab PFS-NSDActive comparatorParticipants will receive a single dose of etrolizumab via SC injection using the PFS-NSD on Day 1.
Receives: Drug: Etrolizumab; Device: Prefilled Syringe With Needle Safety Device (PFS-NSD)
Part 2: Etrolizumab AIExperimentalParticipants will receive a single dose of etrolizumab via SC injection using the AI on Day 1.
Receives: Drug: Etrolizumab; Device: Auto-Injector (AI)
Part 2: Etrolizumab PFS-NSDActive comparatorParticipants will receive a single dose of etrolizumab via SC injection using the PFS-NSD on Day 1.
Receives: Drug: Etrolizumab; Device: Prefilled Syringe With Needle Safety Device (PFS-NSD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Cmax of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

  2. Part 1: AUClast of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

  3. Part 1: AUC0-inf of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

  4. Part 1: Ratio of AUClast to AUC0-inf (AUCR) of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

  5. Part 2: Cmax of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

  6. Part 2: AUClast of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

  7. Part 2: AUC0-inf of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

Secondary outcomes (7)

  1. Part 1: Time to Maximum Observed Concentration (tmax) of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

  2. Part 2: tmax of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

  3. Part 1: Apparent Terminal Elimination Half-Life (t1/2) of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

  4. Part 2: t1/2 of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

  5. Part 2: AUCR of Etrolizumab

    Measured: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)

  6. Percentage of Participants With Adverse Events

    Measured: Part 1 and 2: Baseline up to Day 71

  7. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Etrolizumab

    Measured: Part 1 and 2: Baseline up to Day 71

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2016 (estimated)
  2. Study start7 Dec 2016
  3. Primary completion9 Apr 2018
  4. Study completion9 Apr 2018

Resources

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
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02996019
Sponsor's protocol ID
GX29504
Status last verified
Nov 2018
First submitted
14 Dec 2016
Last updated
3 Dec 2018
Results posted
No

Publications

  • Zhang W, Tyrrell H, Ding HT, Pulley J, Boruvka A, Erickson R, Abouhossein M, Ravanello R, Tang MT. Comparable Pharmacokinetics, Safety, and Tolerability of Etrolizumab Administered by Prefilled Syringe or Autoinjector in a Randomized Trial in Healthy Volunteers. Adv Ther. 2021 May;38(5):2418-2434. doi: 10.1007/s12325-021-01661-6. Epub 2021 Mar 29.

    PubMed 33778929

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Etrolizumab, Auto-Injector (AI) and Prefilled Syringe With Needle Safety Device (PFS-NSD) in people with Healthy Volunteers, run by Genentech, Inc. at 4 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 21 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 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Part 1: Cmax of Etrolizumab (time frame: Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71)). The study lists 7 primary outcomes in all. 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 NCT02996019, 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 3 Dec 2018.

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