PHASE l CLlNlCAL STUDY
STUDY DESIGN
N=159
Phase I, randomized, single-blind, three-arm, parallel group PK study comparing single IV dose (5 mg/kg bw) Flixabi™ with EU- and US-sourced reference infliximab in healthy volunteers.
Baseline to Week 10
Primary PK parameters were AUCinf, AUClast, and Cmax. Safety and immunogenicity.
Adapted from: Shin D, et al. 2015.
Abbreviations: AUC, area under the concentration-time curve; AUCinf, AUC from time zero to infinity; AUClast, AUC from time zero to the last quantifiable concentration; Cmax, maximum concentration; IV, intravenous; PK, pharmacokinetic, IFX, reference infliximab.
Comparable pharmacokinetic profile between Flixabi™ and reference infliximab1
- Similar mean serum concentration time profiles1
- All primary PK parameters within pre-defined equivalence margin1,a
- Comparable incidences of ADAs between treatment arms1
- Comparable frequencies of treatment-emergent adverse events1
Confidence intervals of the test-to-reference ratios are well contained within the
pre-defined equivalence margin.
Adapted from:Shin D, et al. 2015.1
Abbreviations: ADA, anti-drug antibodies; ANOVA, analysis of variance; CI, confidence interval; LSMean,
least squares mean; PK, pharmacokinetic, IFX, reference infliximab.
a Bioequivalence by ANOVA if the 90% CIs for the ratio of geometric LSMeans of the treatments
compared were completely contained within the pre-defined equivalence margin, 0.8–1.25.
