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. 2022 Nov 1;54(11):1850–1861. doi: 10.1038/s12276-022-00870-5

Table 1.

Noncompartmental pharmacokinetic parameters for hFcRn mouse and monkey studies.

Speciesa Parameter t1/2 (day) Cmax (μg mL−1) AUCinf (μg mL−1 day) AUC%Extrap CL (mL day−1)
hFcRn transgenic mouse1 Trastuzumab 7.03 ± 1.16 71.14 ± 3.95 247.08 ± 18.60 0.6 ± 0.25 0.41 ± 0.03
Trastuzumab-PFc29 14.07 ± 2.70 79.30 ± 9.48 528.82 ± 101.78 7.7 ± 3.9 0.21 ± 0.04
Trastuzumab-PFc41 10.90 ± 2.54 67.91 ± 7.60 480.90 ± 60.65 7.0 ± 0.5 0.22 ± 0.02
hFcRn transgenic mouse2 Aflibercept 0.41 ± 0.02 30.55 ± 8.50 15.63 ± 4.06 0.41 ± 0.11 6.40 ± 0.13
Aflibercept-PFc29 2.10 ± 0.63 45.26 ± 4.42 33.66 ± 4.56 0.40 ± 0.35 2.97 ± 0.09
Aflibercept-PFc41 1.01 ± 0.03 39.95 ± 5.32 30.33 ± 2.33 0.78 ± 0.14 3.30 ± 1.18
Cyno Trastuzumab 7.17 ± 0.14 120.38 ± 1.29 881.49 ± 35.68 2.879 ± 0.38 13.64 ± 0.55
Trastuzumab-YTE 8.84 ± 2.81 130.56 ± 17.43 1001.44 ± 154.20 6.17 ± 4.79 12.27 ± 1.89
Trastuzumab-LS 8.88 ± 1.17 177.20 ± 10.32 1263.26 ± 42.53 6.05 ± 2.63 9.51 ± 0.32
Trastuzumab-PFc29 14.34 ± 2.75 228.52 ± 39.46 1966.32 ± 286.39 16.89 ± 5.60 6.24 ± 0.91

t1/2 terminal half-life (β-phase), Cmax maximal concentration, AUCinf area under the curve from administration to infinity, AUC%Extrap percentage of the extrapolated area under the curve to the total area under the curve, CL clearance.

ahFcRn transgenic mouse and Cyno refer to Tg276 mouse (B6.Cg-Fcgrttm1Dcr Tg(CAG-FCGRT)276Dcr/DcrJ homozygous) and in cynomolgus monkey, respectively. Dose levels and routes: single i.v. bolus at 5 mg/kg (n = 5) for hFcRn transgenic mouse1; single i.v. bolus at 4 mg/kg (n = 5) for hFcRn transgenic mouse2; single i.v. infusion at 6 mg/kg (n = 2) for Cyno.