A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab

April 6, 2017 updated by: Bausch Health Americas, Inc.

A Bioequivalence Study Comparing a Single Subcutaneous Injection With a 1.5 mL Prefilled Syringe Versus 2 Subcutaneous Injections of 1 mL and 0.5 mL Prefilled Syringes of Brodalumab 140 mg/mL to Healthy Subjects

A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of Brodalumab

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single 1.5mL dose of Brodalumab (140mg/mL) vs. two doses (1.0mL + 0.5mL) of Brodalumab (140mg/mL)

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • 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
    • California
      • Glendale, California, United States, 91206
        • Research Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Research Site
    • Minnesota
      • St. Paul, Minnesota, United States, 55114
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Research Site
    • Texas
      • Austin, Texas, United States, 78744
        • Research Site
      • San Antonio, Texas, United States, 78209
        • Research Site

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

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy males and females with a BMI between 18.0 and 30.0 kg/m2, inclusive. Females must be of non-reproductive potential

Exclusion Criteria:

  • no history or evidence of clinically significant disorder that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brodalumab (single 1.5mL pre-filled syringe)
A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection
Drug: Brodalumab
Brodalumab is a large molecule for the treatment of inflammatory diseases
Experimental: Brodalumab (2 pre-filled syringes [1.0mL + 0.5mL])
A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections
Drug: Brodalumab
Brodalumab is a large molecule for the treatment of inflammatory diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B.
Time Frame: 60 days
Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection
60 days
Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab
Time Frame: 60 days
Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity
Time Frame: 60 days
Presence of binding or neutralizing anti-brodalumab antibodies
60 days

Collaborators and Investigators

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

Sponsor

Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

September 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 13, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130307

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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