安慰剂
医学
卵泡期
耐受性
药代动力学
药效学
不利影响
内科学
促卵泡激素
内分泌学
激素
药理学
促黄体激素
病理
替代医学
作者
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
标识
DOI:10.1080/13543784.2022.2151434
摘要
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, after baseline adjustment. Over this dose range, the median Tmax occurred at 240-312 h, and the half-life (t½) was 752-1160 h. Dose proportionality was shown across the studied dose range. In most subjects, follicular growth was observed, and the number and diameter of the follicles increased with an increasing dose. In the 40-μg and 60-μg groups, the mean numbers of follicles with a diameter of ≥17 mm were 3 and 4, respectively. There was no significant difference in adverse events between the KN015 and placebo groups. KN015 antibody was not detected in any of the dosage groups.The administration of a single ascending dose of KN015 was tolerated and able to induce follicular growth.This trial is registered at the Chinese Clinical Trials website (http://www.chinadrugtrials.org.cn/index.html # CTR20160741) and ClinicalTrials.gov (https://clinicaltrials.gov/ # NCT03192527).
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