Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of Single Dose of BL0175 in Postmenopausal Women
Sponsor: Shanghai Best-Link Bioscience, LLC
Summary
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
Official title: A Phase I, International, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of BL0175 Injection Compared With a Single Dose of Fulvestrant Injection in Postmenopausal Women
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
27
Start Date
2026-01-26
Completion Date
2026-12-21
Last Updated
2026-01-26
Healthy Volunteers
Yes
Conditions
Interventions
BL0175
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
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.