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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-07

Study Completion Date

2018-04-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Part 1: Etrolizumab AI

Participants will receive a single dose of etrolizumab via subcutaneous (SC) injection using the AI on Day 1.

Group Type EXPERIMENTAL

Etrolizumab

Intervention Type DRUG

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

Auto-Injector (AI)

Intervention Type DEVICE

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

Part 1: Etrolizumab PFS-NSD

Participants will receive a single dose of etrolizumab via SC injection using the PFS-NSD on Day 1.

Group Type ACTIVE_COMPARATOR

Etrolizumab

Intervention Type DRUG

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

Prefilled Syringe With Needle Safety Device (PFS-NSD)

Intervention Type DEVICE

The PFS-NSD will be used to administer etrolizumab.

Part 2: Etrolizumab AI

Participants will receive a single dose of etrolizumab via SC injection using the AI on Day 1.

Group Type EXPERIMENTAL

Etrolizumab

Intervention Type DRUG

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

Auto-Injector (AI)

Intervention Type DEVICE

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

Part 2: Etrolizumab PFS-NSD

Participants will receive a single dose of etrolizumab via SC injection using the PFS-NSD on Day 1.

Group Type ACTIVE_COMPARATOR

Etrolizumab

Intervention Type DRUG

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

Prefilled Syringe With Needle Safety Device (PFS-NSD)

Intervention Type DEVICE

The PFS-NSD will be used to administer etrolizumab.

Interventions

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Etrolizumab

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

Intervention Type DRUG

Auto-Injector (AI)

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

Intervention Type DEVICE

Prefilled Syringe With Needle Safety Device (PFS-NSD)

The PFS-NSD will be used to administer etrolizumab.

Intervention Type DEVICE

Other Intervention Names

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RO5490261

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes