NCT02472912

Adalimumab PK Bioequivalence Study to EU and US Sourced Humira

Single Center, Randomized, Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of BMO-2 to EU and US Sourced Humira, Administered as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adults.

Detailed description

This is a single-center, randomized, double-blind, 3-way parallel study in 270 healthy adult male and female subjects. During this study, the PK bioequivalence of BMO-2, containing 40 mg adalimumab, will be compared to EU licensed Humira® (EU-Humira® ) (40 mg) and US licensed Humira® (US-Humira® ) (40 mg). Randomization will be stratified by body weight (weight categories of 60.0-79.9 kg and 80.0-95.0 kg). After randomization, subjects will receive one of the following treatments: a single sc injection of 40 mg BMO-2, an equivalent sc injection of EU-Humira® (40 mg), or an equivalent sc injection of US-Humira® (40 mg). Volunteers participation in the study is expected to finish with the follow-up visit, scheduled 70 days after the injection of study drug.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	BMO-2	Volunteers randomized in Treatment A will receive a single subcutaneous injection of BMO-2 (40mg / 0.8mL).
BIOLOGICAL	EU-Humira	Volunteers randomized in Treatment B will receive a single subcutaneous injection of EU-Sourced Humira (40 mg / 0/8 mL)
BIOLOGICAL	US-Humira	Volunteers randomized in Treatment C, will receive a single subcutaneous injection of US-sourced Humira (40 mg / 0.8 mL).

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2015-06-16
• Last updated: 2022-03-11

Locations

1 site across 1 country: Belgium