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

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ClinicalTrials.gov Identifier: NCT02173392
Recruitment Status : Completed
First Posted : June 25, 2014
Results First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Brodalumab Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Brodalumab

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: 60 days ]
    Presence of binding or neutralizing anti-brodalumab antibodies


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173392


Locations
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United States, California
Research Site
Glendale, California, United States, 91206
United States, Florida
Research Site
Aventura, Florida, United States, 33180
United States, Minnesota
Research Site
St. Paul, Minnesota, United States, 55114
United States, Nebraska
Research Site
Lincoln, Nebraska, United States, 68502
United States, Texas
Research Site
Austin, Texas, United States, 78744
Research Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02173392    
Other Study ID Numbers: 20130307
First Posted: June 25, 2014    Key Record Dates
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Brodalumab
Dermatologic Agents