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This analysis developed a target\u2010mediated drug disposition (TMDD) model to simultaneously characterize RLYB212 pharmacokinetics (PK) and HPA\u20101a\u2010positive platelet dynamics in HPA\u20101b\/b (HPA\u20101a\u2010negative) volunteers. The model was then used to perform simulations to inform a dosing regimen in a phase II clinical study in pregnant women, where simulations accounted for physiological changes throughout pregnancy. Allometric scaling (0.75) for clearance and intercompartment transfer rate and volume (1) was included in the base model to account for variations in body weight. A 0.06\u2009mg RLYB212 dose with a loading dose of 0.12\u2009mg was identified as the optimal dosing regimen of RLYB212, which maintained exposures below the target upper boundary of ~10\u2009ng\/mL throughout pregnancy. 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