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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
270
Volunteers randomized in Treatment A will receive a single subcutaneous injection of BMO-2 (40mg / 0.8mL).
Volunteers randomized in Treatment B will receive a single subcutaneous injection of EU-Sourced Humira (40 mg / 0/8 mL)
Volunteers randomized in Treatment C, will receive a single subcutaneous injection of US-sourced Humira (40 mg / 0.8 mL).
SGS Belgium NV
Antwerp, Belgium
Area under the plasma concentration versus time curve (AUC) of adalimumab.
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71 days post subcutaneous injection.
Frequency of Adverse Events
Time frame: Up to 71 days.
Safey variable - Tolerability (injection site reactions)
Tolerability assessments as measured by injection site reactions
Time frame: Predose and 1, 2, 3, 7, 9, 36, and 71 days post subcutaneous injection.
Safety variable - immunogenicity (Presence of anti-adalimumab antibodies)
Presence of anti-adalimumab antibodies
Time frame: Day 1 (pre-dose) and Day 9, 29, and 71 days post subcutaneous injection.
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