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N=188 healthy male subjects
Baseline to 57 days
Single-blind, two-arm, parallel group, and single-dose study in which subjects were randomised (1:1) to receive, via SC injection, a single dose of the low volume Imraldi™ (adalimumab) formulation (SB5-HC, 40 mg/0.4 mL) or the original formulation (SB5-LC, 40 mg/0.8 mL). Patents were observed for 57 days following the injection (Day 1) during which the PK, safety profile, and immunogenicity were evaluated.
Primary endpoints were the area under the concentration–time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax). Secondary PK endpoints included area under the concentration–time curve from time zero to the last quantifiable concentration (AUClast), time to Cmax (Tmax), apparent volume of distribution during the terminal phase (Vz/F), terminal rate constant (kz), terminal half-life (t1/2), apparent total body clearance (CL/F), and percentage of AUCinf due to extrapolation from time of last measurable concentration (Tlast) to infinity (%AUCextrap). The safety endpoints were adverse events (AEs) and serious AEs (SAEs), clinical laboratory values, 12-lead ECG, vital signs, physical examination, and injection site assessment. Immunogenicity endpoints were the incidence of ADAs and neutralizing antibodies (NAbs) to ADL.
Adapted from: Ahn S, et al. 2022
Abbreviations: ADA, anti-drug antibodies; ADL, adalimumab; AEs, adverse events; Cmax, maximum observed concentration; EOS, end of study; IP, investigational product; NAbs, neutralising antibodies; PK, pharmacokinetic; SAE, serious adverse events; SC, subcutaneous.
a Equivalence for the primary PK parameters was to be concluded if the 90% confidence intervals (CIs) for the ratio of geometric least squares means (LSMeans) of the treatment groups compared were completely contained within the pre-defined equivalence margin of 0.80 to 1.25 using an analysis of variance.
Adapted from: Ahn S, et al. 2022.
Abbreviations: AUC, area under concentration-time curve; Cmax, maximum observed concentration; LSMeans, geometric least squares means; PK, pharmacokinetic.
Mean (+/- SD) serum SB5-HC and SB5-LC concentration-time-profiles for PC
analysis set; linear (upper graph) and semi-logarithmic (lower graph) scales.
Abbreviations: ADA, anti-drug antibodies; ADL, adalimumab; NAbs, neutralising antibodies; SAE, serious adverse event; TEAE, treatment-emergent adverse event.