PHASE l CLINICAL STUDY

STUDY DESlGN

N=189

Baseline to
Week 10

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.

lmraldi™ pharmacokinetics mirror those of reference adalimumab1

Mean serum concentration-time profiles

Adapted from: Shin D, et al. 2017.