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A Study of Single Dose of BL0175 in Postmenopausal Women

NCT07366632 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-01-26

No results posted yet for this study

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

Conditions

  • Postmenopausal Women

Interventions

DRUG

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

DRUG

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.

Sponsors & Collaborators

  • Shanghai Best-Link Bioscience, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-26
Primary Completion
2026-05-08
Completion
2026-12-21
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07366632 on ClinicalTrials.gov