Safety and Tolerability of TWP-201 in Healthy Female Subjects

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04878705
• Other study ID #: TWP-201-11
• Status: Recruiting
• Phase: Phase 1
• Start date: May 17, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Shandong TheraWisdom Biopharma Co., Ltd.
• Contact: Shengbin Ren
• Phone: 8021-60167707
• Email: shengbin.ren[@]therawisdom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• TWP-201
a single subcutaneous injection
• placebo
a single subcutaneous injection

Locations

Country	Name	City	State
China	West China Second University Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Shandong TheraWisdom Biopharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum measured plasma concentration (Cmax) of TWP-201;		28 days
Secondary	Time to maximum plasma concentration (Tmax) of TWP-201;		28 days
Secondary	Half-life (T1/2) of TWP-201.		28 days
Secondary	Pharmacodynamics(PD).	Determination of serum concentrations of FSH, E2 and LH after dosing.	28 days
Secondary	Pharmacodynamics(PD).	The number of follicles after dosing. The size of follicles after dosing.	28 days
Secondary	Immunogenicity profile of TWP-201.	Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.	28 days