Arthritis, Rheumatoid Clinical Trial
Official title:
A Phase 1 Randomized Blinded Single Dose Comparison of the Safety and Pharmacokinetics of SYN060 Compared to Adalimumab (Humira®) From North American and European Sources in Healthy Adult Subjects
This is a single site, parallel randomized, double blinded comparison of the safety, pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American and European sources. The study is open to healthy individuals on no medications that might confound the results of this safety study.
This is a single site, parallel randomized, double blinded comparison of the safety,
pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57
mg/kg dose of adalimumab (Humira®) reference product from North American and European
sources. The study is open to healthy individuals on no medications that might confound the
results of this safety study.
A total of 90 subjects will be randomized in a 1:1:1 ratio to from a centrally generated
randomization schedule to SYN060 or adalimumab of American or European sources resulting in
30 subjects in each group.
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