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

November 1, 2016 updated by: Genentech, Inc.

A Phase I, Randomized, Open-Label, Parallel-Group, Single-Dose, Multi-Center Study in Healthy Subjects to Investigate the Bioequivalence Between a High-Concentration Formulation of Lebrikizumab Administered Subcutaneously by a Needle and Syringe and a Low-Concentration Formulation of Lebrikizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD)

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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
    • Indiana
      • Evansville, Indiana, United States, 47710
    • Texas
      • Dallas, Texas, United States, 75247
    • Wisconsin
      • Madison, Wisconsin, United States, 53704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Lebrikizumab
Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.
Experimental: Treatment 2: PFS-NSD
Healthy volunteers will receive a single SC injection of lebrikizumab, administered by PFS-NSD.
Drug: Lebrikizumab
Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum observed concentration (Cmax) of lebrikizumab
Time Frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time to maximum concentration (Tmax) of lebrikizumab
Time Frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Area under the concentration-time curve to the last measurable concentration (AUC0-last) of lebrikizumab
Time Frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of lebrikizumab
Time Frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent terminal elimination rate constant of lebrikizumab
Time Frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent terminal elimination half-life (t1/2) of lebrikizumab
Time Frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent clearance (CL/F) of lebrikizumab
Time Frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent volume of distribution (Vz/F) of lebrikizumab
Time Frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: From Day -1 until study completion or premature withdrawal (up to approximately 3 months)
From Day -1 until study completion or premature withdrawal (up to approximately 3 months)
Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab
Time Frame: From Day 1 until study completion or premature withdrawal (up to approximately 3 months)
From Day 1 until study completion or premature withdrawal (up to approximately 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GP29651

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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