Safety and Tolerability of TWP-201 in Healthy Female Subjects

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    Shandong TheraWisdom Biopharma Co., Ltd.
Updated on 27 July 2021
body mass index


This study is a randomized, double-blind, placebo-controlled, single dose, escalation, phase I clinical trial to evaluate the safety and tolerability of recombinant human follicle stimulating hormone Fc fusion protein injection (TWP-201) in healthy female subjects. The objective of the trial is to evaluate the safety and tolerability of TWP-201 in healthy female subjects.

Condition Female Genital Diseases, Infertility, sterility, unable to conceive
Treatment Placebo, TWP-201
Clinical Study IdentifierNCT04878705
SponsorShandong TheraWisdom Biopharma Co., Ltd.
Last Modified on27 July 2021


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Inclusion Criteria

Body weight 45 kg, 19 body mass index (BMI) 28 kg /m2
Women with sexual experience, potential fertility and regular menstrual cycle (25-34 days) (including boundary value)
The levels of sex hormones were normal or abnormal without clinical significance at the time of screening
The physiological structure of uterus and bilateral ovaries was normal or abnormal by ultrasound examination, without clinical significance

Exclusion Criteria

Known the history of stage III / IV endometriosis, submucosal myoma and endocrine abnormality within 6 months before enrollment
Known the history of ovarian hyperstimulation syndrome (OHSS)
Premature ovarian failure, decreased ovarian reserve function (Antral Follicle Counting < 3), high ovarian response, polycystic ovary syndrome, unexplained vaginal bleeding or endometrial hyperplasia
Any FSH or HMG preparations were used within 3 months before the first study
Pregnancy or lactating women
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