Establishing clinical equlvalence

N=189

Baseline to
Week 10

Phase I, randomised, three-arm, parallel-group, PK study comparing SC Imraldi^TM (40 mg) with EU-and US-sourced rADL (40 mg) in healthy volunteers

ADL concentrations were determined using ELISA. PK endpoints were: AUC_inf, AUC_last and C_max. Safety profile and immunogenicity