Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects

Summary

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.

Timeline

Start

2017-09-26

Primary completion

2018-07-17

Completion

2018-07-17

Drugs

Indications