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: * What medical problems do participants have when using drug BL0175? * How long can BL0175 remain in your blood? Participants will receive a single dose of drug BL0175 or a single dose of Fulvestrant Injection in a randomized method
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
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
Fulvestrant Injection has been marked in many country and regions for the treatment of women who have been through menopause with: * hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer who have not been previously treated with endocrine therapy. * HR positive, locally advanced or metastatic breast cancer who have progressive disease following prior endocrine (anti-oestrogen or aromatase inhibitor) therapy. 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.
Number of participants with adverse events as assessed by CTCAE v6.0
Time frame: from Day 1 to Day 57
Pharmacokinetics (PK) parameters-Maximum concentration (Cmax) of fulvestrant
Time frame: From Day 1 to Day 197
Serious adverse events (SAE) that related to investigational product
Time frame: up to 197 days
Pharmacokinetics (PK) parameters-Area under the concentration curve (AUC) of fulvestrant
Time frame: From Day 1 to Day 197
Half-life (t1/2)of fulvestrant
Time frame: From Day 1 to Day 197
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