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Safety and Tolerability of TWP-201 in Healthy Female Subjects

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TWP-201
placebo
Sponsored by
Shandong TheraWisdom Biopharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • West China Second University Hospital, Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TWP-201

placebo

Arm Description

Outcomes

Primary Outcome Measures

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)).

Secondary Outcome Measures

Maximum measured plasma concentration (Cmax) of TWP-201;
Time to maximum plasma concentration (Tmax) of TWP-201;
Half-life (T1/2) of TWP-201.
Pharmacodynamics(PD).
Determination of serum concentrations of FSH, E2 and LH after dosing.
Pharmacodynamics(PD).
The number of follicles after dosing. The size of follicles after dosing.
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.

Full Information

First Posted
April 29, 2021
Last Updated
July 15, 2021
Sponsor
Shandong TheraWisdom Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04878705
Brief Title
Safety and Tolerability of TWP-201 in Healthy Female Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong TheraWisdom Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TWP-201
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TWP-201
Intervention Description
a single subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
a single subcutaneous injection
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Maximum measured plasma concentration (Cmax) of TWP-201;
Time Frame
28 days
Title
Time to maximum plasma concentration (Tmax) of TWP-201;
Time Frame
28 days
Title
Half-life (T1/2) of TWP-201.
Time Frame
28 days
Title
Pharmacodynamics(PD).
Description
Determination of serum concentrations of FSH, E2 and LH after dosing.
Time Frame
28 days
Title
Pharmacodynamics(PD).
Description
The number of follicles after dosing. The size of follicles after dosing.
Time Frame
28 days
Title
Immunogenicity profile of TWP-201.
Description
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Time Frame
28 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengbin Ren
Phone
8021-60167707
Email
shengbin.ren@therawisdom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengbin Ren
Organizational Affiliation
Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Second University Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Yu
Phone
8028-85501952
Email
908929936@qq.com
First Name & Middle Initial & Last Name & Degree
Lingli Zhang
Phone
8028-85501952
Email
zhanglingli@scu.edu.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Tolerability of TWP-201 in Healthy Female Subjects

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