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

NCT02173392 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2017-06-20

Study results available
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Summary

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

Conditions

Interventions

DRUG

Brodalumab

Brodalumab is a large molecule for the treatment of inflammatory diseases

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02173392 on ClinicalTrials.gov