Single Dose Recombinant Human Follicle Stimulating Hormone Fc Husion Protein (KN015) in Healthy Volunteers
Status:
Unknown status
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
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.