A Randomized, Double-blind, Placebo-controlled, Single Dose, Escalation, Phase I Clinical Trial to Evaluate the Safety and Tolerability of TWP-201 in Healthy Female Subjects

Shandong TheraWisdom Biopharma Co., Ltd.1 site in 1 country48 target enrollmentMay 17, 2021

ConditionsInfertility

InterventionsTWP-201 placebo

DrugsTWP-201 placebo

Overview

Phase: Phase 1
Intervention: TWP-201
Conditions: Infertility
Sponsor: Shandong TheraWisdom Biopharma Co., Ltd.
Enrollment: 48
Locations: 1
Primary Endpoint: Incidence of adverse events, serious adverse and abnormal laboratory values event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 17, 2021

End Date

December 31, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Shandong TheraWisdom Biopharma Co., Ltd.

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

TWP-201

Intervention: TWP-201

placebo

Intervention: placebo

Outcomes

Primary Outcomes

Incidence of adverse events, serious adverse and abnormal laboratory values event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).

Time Frame: An average of 1 year