A Study of Single Dose of BL0175 in Postmenopausal Women
ConditionPostmenopausal Women
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorShanghai Best-Link Bioscience, LLC
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BL0175
DrugBL0175 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
DrugFulvestrant 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.
Treatment groups
27 Participants
are divided into 2 treatment groupsGroup A: BL0175 250mgExperimental treatment 1 intervention
Group B: Fulcestrant 250mgActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with adverse events as assessed by CTCAE v6.0
Time frame
from Day 1 to Day 57Secondary outcomes
1
Pharmacokinetics (PK) parameters-Maximum concentration (Cmax) of fulvestrant
Time frame
From Day 1 to Day 1972
Serious adverse events (SAE) that related to investigational product
Time frame
up to 197 days3
Pharmacokinetics (PK) parameters-Area under the concentration curve (AUC) of fulvestrant
Time frame
From Day 1 to Day 1974
Half-life (t1/2)of fulvestrant
Time frame
From Day 1 to Day 197Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: