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
Qualifiers
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
Treatments tested in this trial
- BL0175
- Fulvestrant
Treatment groups
27 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov