Status and phase
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Treatments
About
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs. Humira® AC Pen [Reference Product]
Full description
This is a phase 1 pharmacokinetic, safety and immunogenicity comparative, single-dose, double-blind, randomized, balanced parallel-group clinical study conducted in healthy subjects of both sexes.
Blood samples are collected for up to 71 days to determine the quantification of adalimumab and for 12 months for antidrug antibody detection. Safety and tolerability are also assessed.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Written and signed informed consent
Target population
Age and gender
Exclusion criteria
Medical history and concurrent illnesses
Physical findings and laboratory tests
Sex and reproductive condition
Allergies, adverse drug reactions and contraindications
Prohibited treatments and/or therapies
Other exclusion criteria
The eligibility criteria for this clinical research protocol have been considered to guarantee the safety of the study subjects and ensure that their results can be used.
Primary purpose
Allocation
Interventional model
Masking
150 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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