Overview
A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab
Status:
Completed
Completed
Trial end date:
2014-12-01
2014-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of BrodalumabPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Amgen
Bausch Health Americas, Inc.Treatments:
Brodalumab
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.