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

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: Brodalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02173392

20130307

Details and patient eligibility

About

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

Full 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)

Enrollment: 145 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

Brodalumab (single 1.5mL pre-filled syringe)

Experimental group

Description:

A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection

Treatment:

Drug: Brodalumab

Brodalumab (2 pre-filled syringes [1.0mL + 0.5mL])

Experimental group

Description:

A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections

Treatment:

Drug: Brodalumab