This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate TUR01 to EU-sourced Humira® in healthy participants after administration of adalimumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
168
Administered as a single 40 mg, subcutaneous dose
Administered as a single 40 mg, subcutaneous dose
PAREXEL International GmbH, Early Phase Clinical Unit Berlin
Berlin, Germany
Area under the concentration-time curve from time 0 to infinity (AUCinf)
AUCinf = area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) + last observed concentration (Ct)/terminal rate constant (λz)
Time frame: Day 1 - Day 71
Maximum serum concentration (Cmax)
Cmax
Time frame: Day 1 - Day 71
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
Time frame: Day 1 - Day 71
Area under the concentration-time curve from time zero to 336 hours (AUC336)
Area under the concentration-time curve from time zero to 14 days
Time frame: Day 1 - Day 15
Area under the concentration-time curve from time zero to 672 hours (AUC672)
Area under the concentration-time curve from time zero to 28 days
Time frame: Day 1 - Day 29
Area under the concentration-time curve from time zero to 1008 hours (AUC1008)
Area under the concentration-time curve from time zero to 42 days
Time frame: Day 1 - Day 43
Area under the concentration-time curve from time zero to 1680 hours (AUC1680)
Area under the concentration-time curve from time zero to 70 days
Time frame: Day 1 - Day 71
Time to Cmax (Tmax)
Time to reach the maximum concentration
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Time frame: Day 1 - Day 71
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Day 1 - Day 71
Terminal rate constant (λz)
The parameter will be calculated by linear least squares regression analysis using at least 3 non-zero concentrations in the terminal phase
Time frame: Day 1 - Day 71
Terminal half-life calculated by ln(2)/λz (t½)
Time frame: Day 1 - Day 71
Apparent total body clearance (CL/F)
Time frame: Day 1 - Day 71
Area under the concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)
Time frame: Day 1 - Day 71