Establishing clinical equlvalence

PHASE l CLINICAL STUDY

STUDY DESlGN1

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

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.

REFERENCES

lmraldi™ pharmacokinetics mirror those of reference adalimumab1

Mean serum concentration-time profiles

Adapted from: Shin D, et al. 2017.