Safety and Tolerability of TWP-201 in Healthy Female Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* Drug: TWP-201
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TWP-201<br> | Drug: TWP-201<br>* a single subcutaneous injection<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* a single subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |