Select a country
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
Primary endpoint: PK equivalence ( AUCinf, AUClast and Cmax). Serum adalimumab (ADL) concentrations were measured using ELISA. Secondary endpoints: Safety profile and immunogenicity
No discontinuations due to treatment-emergent adverse events (TEAEs) or deaths were reported. Number and kind of TEAEs were comparable between the three groups and considered mild to moderate. The incidence of subjects with antidrug antibodies (ADA) and the overall incidence of neutralizing antibody (NAb) were comparable across the three groups.
Abbreviations: rADL, reference adalimumab; ELISA, enzyme linked immunosorbent assay; PK, pharmacokinetics; SC, subcutaneous.
Adapted from: Shin D, et al. 2017.