Table. 1.
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.