The effect of a single escalating dose of long-acting recombinant human follicle-stimulating hormone Fc fusion protein (KN015) on healthy, pituitary-suppressed women: first-in-human and randomized study on its pharmacokinetics, pharmacodynamics, and tolerability

Hong Zhang, Yanyan Fan, Lei Gao, Boguang Wang, Ting Xu, Min Wu, Jingrui Liu, Xiaoxue Zhu, Xiaojiao Li, Hong Chen, Cuiyun Li, Meng Wang, Chengjiao Liu, Yanhong Mao, Mingtang Yang & Yanhua Ding
KN015 is a long-acting, recombinant human follicle-stimulating hormone Fc fusion protein that induces follicle development. This first-in-human study evaluated the effect of KN015 on healthy, pituitary-suppressed women and examined its pharmacokinetics, pharmacodynamics, and tolerability. This phase I study was a double-blind, randomized, and placebo-controlled design with a single ascending dose (20, 40, and 60 μg, respectively). After subcutaneous administration of a single dose, the maximum serum KN015 concentrations reached 1.57, 2.78, and 3.62 ng/mL, respectively,...
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