Safety and Tolerability of TWP-201 in Healthy Female Subjects

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shandong TheraWisdom Biopharma Co., Ltd.

Criteria

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.