MedDataX Logo

A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)

NCT ID: NCT02486809

Last Updated: 2016-11-02

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single injection via PFS-NSD.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment 1: Needle and Syringe

Healthy volunteers will receive a single SC injection of lebrikizumab, withdrawn from a vial and administered by a needle and syringe.

Group Type EXPERIMENTAL

Lebrikizumab

Intervention Type DRUG

Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.

Treatment 2: PFS-NSD

Healthy volunteers will receive a single SC injection of lebrikizumab, administered by PFS-NSD.

Group Type EXPERIMENTAL

Lebrikizumab

Intervention Type DRUG

Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lebrikizumab

Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy adults 18 to 65 years of age, inclusive
* Body mass index (BMI) 18 to 32 kg/m\^2 and body weight 50 to 100 kg, inclusive
* Nonpregnant and nonlactating females
* Agreement to utilize effective contraception among men and women of childbearing potential

Exclusion Criteria

* Known allergy or hypersensitivity to study drug or components
* History of alcohol or drug abuse within 12 months prior to study drug, or positive test for alcohol or drugs of abuse
* Receipt of an investigational agent within 30 days of 5 half-lives prior to Day -1
* Biological therapy within 90 days prior to Day -1
* Parasitic or Listeria monocytogenes infection within 6 months prior to Screening
* Receipt of blood products within 2 months prior to study entry
* Donation or loss of blood/plasma within up to 6 months prior to study drug, depending upon volume
* Receipt of live attenuated vaccine within 1 month prior to study drug
* Use of tobacco- or nicotine-containing products within 14 days prior to Screening
* Use of any prescription or nonprescription medication within 14 days prior to study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Daytona Beach, Florida, United States

Site Status

Evansville, Indiana, United States

Site Status

Dallas, Texas, United States

Site Status

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GP29651

Identifier Type: -

Identifier Source: org_study_id