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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TWP-201 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TWP-201 | Drug | a single subcutaneous injection |
| |
| placebo |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengbin Ren | Contact | 8021-60167707 | shengbin.ren@therawisdom.com |
| Name | Affiliation | Role |
|---|---|---|
| Shengbin Ren | Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Second University Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Drug |
a single subcutaneous injection |
|
| 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 |