Postmenopausal WomenPhase 1NCT07366632
A Study of Single Dose of BL0175 in Postmenopausal Women
A Phase 1 study testing BL0175 and Fulvestrant in people with Postmenopausal Women, run by Shanghai Best-Link Bioscience, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- BL0175 and Fulvestrant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 26 Jan 2026to 21 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the study, be able to understand the requirements of a clinical study, and sign informed consent form.
- Postmenopausal female participants aged ≥ 18 years old.
- Body weight ≥ 45kg and body mass index (BMI= weight/height2) scores ≥ 18 kg/m2 and ≤ 35 kg/m2.
- Participants with laboratory tests, physical examinations, vital signs, and electrocardiogram (ECG) results judged by the investigator as normal or abnormal with no clinical significance (NCS).
Who cannot join
- Participants with a history or current presence of any cardiovascular, gastrointestinal, endocrine, hematological, hepatic, immunological, metabolic, urinary, pulmonary, neurological, dermatological, psychiatric, renal, and/or other major diseases that are considered clinically significant by the investigator.
- A history of allergy to fulvestrant, alcohol, castor oil, benzyl alcohol, benzyl benzoate or any other comparable or similar products, or prone to allergic reactions (such as: prone to angioedema, urticaria, asthma, rash, etc.), or history of allergy to two or more drugs (or foods).
- Participants with current concomitant sciatica, neuralgia, or peripheral neuropathy.
- History of allogeneic transplantation of organs, bone marrow or stem cell.
- Active infection, a known history of hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection or screening for infectious disease (HBsAg, hepatitis C virus antibody [HCV-Ab], or human immunodeficiency virus antigen/antibody [HIV-Ag/Ab]) during the screening period is positive.
- Unable to refrain from or anticipate the use of any prescription medications not for the treatment of concomitant diseases within 4 weeks prior to administration, or any over-the-counter drugs (including but not limited to Chinese herbal medicines, compound preparations of Chinese herbal medicines, health products, etc.) not for the treatment of concomitant diseases within 2 weeks prior to administration.
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- Participants who are vaccinated within 14 days prior to dosing administration.
- Those who donated plasma or blood within 12 weeks prior to the dosing administration or donated or lost blood 400 mL or more within 12 weeks prior to the dosing administration, or plan to donate during the study.
- Any history of coagulation dysfunction, bleeding diathesis (e.g., disseminated intravascular coagulation, coagulation factor deficiencies), long-term anticoagulant therapy (excluding antiplatelet therapy and low-dose warfarin), active bleeding (such as gastrointestinal bleeding), or clinically significant thrombocytopenia.
- Intolerance to / fear of venipuncture, needles, or blood collection difficulties (such as poor vascular conditions, fear of blood collection, needle dizziness, etc.).
- Those who underwent major surgery within 4 weeks before screening, or plan to undergo major surgery during the study.
- Those who have taken/used investigational drugs, vaccines or devices within the 4 weeks or 5 half-lives of investigational drug (whichever is longer) prior to the dosing administration.
- Participants who with a history of alcoholism, or with a history of alcohol abuse within 3 months prior to screening (by self-declaration) > 14 alcohol units per week (1 alcohol unit is about equal to 50° white wine 35 mL or 5° beer 350 mL or wine 150 mL). Participants are unable/unwilling to refrain from alcohol, or strenuous exercise 48 hours prior to each study visit.
- Participants who with a history of drug abuse or drug dependence, or those who have used illicit drugs within 1 year prior to screening.
- Positive alcohol or drug screen results at Baseline.
- Those who are determined by the investigator to be ineligible for other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- BL0175, Fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL0175Drug
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
FulvestrantDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BL0175 250mg | Experimental | Not described Receives: Drug: BL0175 |
| Fulcestrant 250mg | Active comparator | Not described Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as assessed by CTCAE v6.0
Measured: from Day 1 to Day 57
Secondary outcomes (4)
Pharmacokinetics (PK) parameters-Maximum concentration (Cmax) of fulvestrant
Measured: From Day 1 to Day 197
Serious adverse events (SAE) that related to investigational product
Measured: up to 197 days
Pharmacokinetics (PK) parameters-Area under the concentration curve (AUC) of fulvestrant
Measured: From Day 1 to Day 197
Half-life (t1/2)of fulvestrant
Measured: From Day 1 to Day 197
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start26 Jan 2026 (estimated)
- Primary completion8 May 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Best-Link Bioscience, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366632
- Sponsor's protocol ID
- BL0175-101
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07366632
- Acronym / sponsor ID
- BL0175-101
- Conditions
- Postmenopausal Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Shanghai Best-Link Bioscience, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (estimated)
- Primary completion
- 8 May 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL0175 250mg | Experimental | Drug: BL0175 |
| Fulcestrant 250mg | Active comparator | Drug: Fulvestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteer to participate in the study, be able to understand the requirements of a clinical study, and sign informed consent form.
- Postmenopausal female participants aged ≥ 18 years old.
- Body weight ≥ 45kg and body mass index (BMI= weight/height2) scores ≥ 18 kg/m2 and ≤ 35 kg/m2.
- Participants with laboratory tests, physical examinations, vital signs, and electrocardiogram (ECG) results judged by the investigator as normal or abnormal with no clinical significance (NCS).
Key exclusion criteria (16 listed)
- Participants with a history or current presence of any cardiovascular, gastrointestinal, endocrine, hematological, hepatic, immunological, metabolic, urinary, pulmonary, neurological, dermatological, psychiatric, renal, and/or other major diseases that are considered clinically significant by the investigator.
- A history of allergy to fulvestrant, alcohol, castor oil, benzyl alcohol, benzyl benzoate or any other comparable or similar products, or prone to allergic reactions (such as: prone to angioedema, urticaria, asthma, rash, etc.), or history of allergy to two or more drugs (or foods).
- Participants with current concomitant sciatica, neuralgia, or peripheral neuropathy.
- History of allogeneic transplantation of organs, bone marrow or stem cell.
- Active infection, a known history of hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection or screening for infectious disease (HBsAg, hepatitis C virus antibody [HCV-Ab], or human immunodeficiency virus antigen/antibody [HIV-Ag/Ab]) during the screening period is positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL0175BL0175 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 | BL0175 250mg |
| FulvestrantFulvestrant 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. | Drug | Fulcestrant 250mg |
Primary outcome
Number of participants with adverse events as assessed by CTCAE v6.0
Time frame: from Day 1 to Day 57
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BL0175 and Fulvestrant in people with Postmenopausal Women, run by Shanghai Best-Link Bioscience, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang (+86 18357916536, fangzhuolun@bestlinkbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as assessed by CTCAE v6.0 (time frame: from Day 1 to Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.