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Phase I, randomised, three-arm, parallel-group, PK study comparing SC ImraldiTM (40 mg) with EU-and US-sourced rADL (40 mg) in healthy volunteers
ADL concentrations were determined using ELISA. PK endpoints were: AUCinf, AUClast and Cmax. Safety profile and immunogenicity
Abbreviations: rADL, reference adalimumab; ELISA, enzyme linked immunosorbent assay; PK, pharmacokinetics; SC, subcutaneous.
Adapted from: Shin D, et al. 2017.