First-in-human trial assessing the pharmacokinetic-pharmacodynamic profile of a novel recombinant human chorionic gonadotropin in healthy women and men of reproductive age.

ABSTRACT: The purpose of this first-in-human trial was to examine the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a novel recombinant human chorionic gonadotropin (rhCG; FE 999302, choriogonadotropin beta) to support its clinical development for various therapeutic indications. The single and multiple dose PK of choriogonadotropin beta (CG beta) were evaluated in women and the single dose PK and PD of CG beta were compared to those of CG alfa in men. CG beta was safe and well-tolerated in all 84 healthy subjects. In women, the area under the curve (AUC) and the peak serum concentration (C_max ) increased approximately dose proportionally following single and multiple doses of CG beta. The apparent clearance (CL/F) was ~ 0.5 L/h, the mean terminal half-life (t_½ )

SUBMITTER: Brokso Kyhl LE 

PROVIDER: S-EPMC8301557 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature