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. 2024 May 7;15:3804. doi: 10.1038/s41467-024-47460-9

Table. 1.

Estimated FIH dose parameters for mRNA-3927, mRNA-3705, and mRNA-3210 based on PK/PD modeling

mRNA-3927 mRNA-3705 mRNA-3210
LNP formulation SM-86/OL-56 SM-86/OL-56 SM-86/OL-56
Starting dose (mg/kg) 0.3 0.1 0.4
FIH dose species Pcca−/− (A138T) mouse, Sprague-Dawley rat, cynomolgus monkey CD1 and Mut−/−;TgINS-CBA-G715V mouse, Sprague-Dawley rat, cynomolgus monkey C57BL/6 B6.BTRB-PAHenu2+/+ (wild-type) and PAHenu2 mouse, cynomolgus monkey
NOAEL (mg/kg) 3 5 3
Safety relevant species Sprague-Dawley rat Sprague-Dawley rat Sprague-Dawley rat
Safety margin 10 50 7.5

FIH first-in-human, LNP lipid nanoparticle, mRNA messenger RNA, NOAEL no-observed-adverse-effect-limit, PD pharmacodynamic, PK pharmacokinetic.