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

Completed · Phase 1

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID

NCT02173392

Run by

Bausch Health Americas, Inc.

People needed

145

Starts

2014-09-01

Expected to finish

2014-12-01

Last updated by the study team

2017-06-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Research Site — Glendale, California, United States
• Research Site — Aventura, Florida, United States
• Research Site — Saint Paul, Minnesota, United States
• Research Site — Lincoln, Nebraska, United States
• Research Site — Austin, Texas, United States
• Research Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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