Overview

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.