Pharmacokinetics Clinical Trial
Official title:
A Randomized, Double-blind, Parallel Groups, Phase 1 Clinical Study Comparing the Pharmacokinetic, Safety and Immunogenicity of Adalimumab in Healthy Subjects
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]
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. ;
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