Safety and Tolerability of TWP-201 in Healthy Female Subjects

Phase 1

• Conditions: Infertility
• Interventions: Drug: TWP-201; Drug: placebo

• Registration Number: NCT04878705
• Lead Sponsor: Shandong TheraWisdom Biopharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-07
• Study Start: 2021-05-17
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-19
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TWP-201	TWP-201	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
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)).	An average of 1 year

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics(PD).	28 days	The number of follicles after dosing. The size of follicles after dosing.
Maximum measured plasma concentration (Cmax) of TWP-201;	28 days
Time to maximum plasma concentration (Tmax) of TWP-201;	28 days
Half-life (T1/2) of TWP-201.	28 days
Immunogenicity profile of TWP-201.	28 days	Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.

Trial Locations

Locations (1)

West China Second University Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China