NCT02173392

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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)

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Brodalumab	Brodalumab is a large molecule for the treatment of inflammatory diseases

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2014-06-25
• Last updated: 2017-06-20
• Results posted: 2017-06-20

Locations

6 sites across 1 country: United States