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Study Complete
Sponsor ID
20130307

A bioequivalence study comparing a single 1.5mL dose of Brodalumab vs. two doses (1.0mL + 0.5mL) of Brodalumab

Sponsor ID
20130307
Clinicaltrials.gov ID
NCT02173392
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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)

Additional Study Details

Phase
Phase 1
Product
AMG 827
Type
Interventional
Masking
None (Open Label)
Enrollment
145
Additional Study Details

Protocol Summary

Primary Outcome Measures

Pharmacokinetic bioequivalence

Timeframe: 60 days

Secondary Outcome Measures

Safety and Tolerability

Timeframe: 60 days

Immunogenicity

Timeframe: 60 days

Other PK parameters

Timeframe: 60 days

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Aventura, FL, United States, 33180
Status
Recruiting
Location
Research Site
San Antonio, TX, United States, 78209
Status
Recruiting
Location
Research Site
Lincoln, NE, United States, 68502
Status
Recruiting
Location
Research Site
St. Paul, MN, United States, 55114
Status
Recruiting
Location
Research Site
Austin, TX, United States, 78744
Status
Completed
Location
Research Site
Glendale, CA, United States, 91206
Status
Completed
Study Info
Age
18 - 55 Years
Condition
  • Healthy Subjects
    • Sex
    All
    Trial Dates
    Sep 2014 - Nov 2014
    Inclusion and Exclusion 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.