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The goal of this clinical trial is to learn the safety and PK of the single dose of BL0175 Injection in postmenopausal women and to compare that with a single dose of Fulvestrant Injection. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BL0175 250mg | Experimental |
| |
| Fulcestrant 250mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL0175 | Drug | BL0175 is a polymer-drug conjugate, composed of a steroidal estrogen receptor antagonist fulvestrant covalently linked to a PEG-modified poly- polymer via a peptide based cleavable linker |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as assessed by CTCAE v6.0 | from Day 1 to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameters-Maximum concentration (Cmax) of fulvestrant | From Day 1 to Day 197 | |
| Serious adverse events (SAE) that related to investigational product | up to 197 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang | Contact | +86 18357916536 | fangzhuolun@bestlinkbio.com |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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| Fulvestrant | Drug | Fulvestrant Injection has been marked in many country and regions for the treatment of women who have been through menopause with:
Fulvestrant stops some of the actions of oestrogen within the body. Oestrogen is a female sex hormone that may help cancer cells grow in women with breast cancer. |
|
| Pharmacokinetics (PK) parameters-Area under the concentration curve (AUC) of fulvestrant |
| From Day 1 to Day 197 |
| Half-life (t1/2)of fulvestrant | From Day 1 to Day 197 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |