Safety and Tolerability of TWP-201 in Healthy Female Subjects

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Drug: TWP-201; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shengbin Ren; Phone Number: 8021-60167707; Email: shengbin.ren@therawisdom.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Second University Hospital, Sichuan University
      • Contact: Qin Yu; Phone Number: 8028-85501952; Email: 908929936@qq.com
      • Contact: Lingli Zhang; Phone Number: 8028-85501952; Email: zhanglingli@scu.edu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; a single subcutaneous injection
Experimental: TWP-201	Drug: TWP-201; a single subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
Pharmacodynamics(PD).	Determination of serum concentrations of FSH, E2 and LH after dosing.	28 days
Pharmacodynamics(PD).	The number of follicles after dosing. The size of follicles after dosing.	28 days
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

Collaborators and Investigators

• Sponsor: Shandong TheraWisdom Biopharma Co., Ltd.
• Investigators: Principal Investigator: Shengbin Ren, Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: TWP-201-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No