Single Dose Recombinant Human Follicle Stimulating Hormone Fc Husion Protein (KN015) in Healthy Volunteers

Summary

KN015,the active substance recombinant human Follicle Stimulating Hormone（FSH） Fc fusion protein, which belongs to the pharmaceutical class gonadotropins.KN015 is proposed for Assisted Reproductive Technology (ART) programs only. Its indication is Controlled Ovarian Stimulation （COS）in combination with a gonadotropin releasing hormone (GnRH) antagonist for the development of multiple follicles in women participating in an ART program. Due to its prolonged duration of FSH activity compared to conventional recombinant FSH (rFSH), a single subcutaneous injection of the recommended dose of KN015 may replace any daily rFSH preparation in a COS treatment cycle. This study is to evaluation of the safety, tolerability, pharmacokinetics and pharmacodynamics of KN015 in healthy Chinese female subjects.

Timeline

Start

2017-06

Primary completion

2019-03

Completion

2019-06

Publications

• Zhang H, Fan Y, Gao L, Wang B, Xu T, Wu M, Liu J, Zhu X, Li X, Chen H, Li C, Wang M, Liu C, Mao Y, Yang M, Ding Y. 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. Expert Opin Investig Drugs. 2022 Nov;31(11):1255-1263. doi: 10.1080/13543784.2022.2151434. Epub 2022 Dec 20.

Drugs

Indications