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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173392
• Other study ID #: 20130307
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2014
• Last updated: March 17, 2015
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Brodalumab
Brodalumab is a large molecule for the treatment of inflammatory diseases

Locations

Country	Name	City	State
United States	Research Site	Austin	Texas
United States	Research Site	Aventura	Florida
United States	Research Site	Glendale	California
United States	Research Site	Lincoln	Nebraska
United States	Research Site	San Antonio	Texas
United States	Research Site	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic bioequivalence	PK parameters AUClast and Cmax for brodalumab	60 days	No
Secondary	Safety and Tolerability	Subject incidence of adverse events, vital signs, clinical laboratory tests, and standard of care electrocardiograms	60 days	Yes
Secondary	Immunogenicity	Presence of binding or neutralizing anti-brodalumab antibodies	60 days	Yes
Secondary	Other PK parameters	Other brodalumab PK parameters including AUCinf and tmax	60 days	No

External Links

•   AmgenTrials clinical trials website