This is a randomized, double-blind, placebo-controlled, multiple-dose escalation, Phase Ib clinical study conducted in patients with abnormal uterine bleeding (e.g., AUB). It aims to evaluate the safety, efficacy, pharmacokinetic characteristics of multiple administrations of BT-114143 Injection at different doses, as well as to explore changes in coagulation-related biomarkers and quality of life.
It is planned to enroll 39 adult patients with abnormal uterine bleeding.
Be able to sign the informed consent form before any study-related procedures are performed, and be willing and able to comply with the study requirements;
Premenopausal female subjects, aged 18-50 years, including 18 and 50 years;
Have regular menstrual cycles in the past 6 months, with a menstrual cycle of ≥21 days and ≤35 days, and a menstrual period duration of ≤14 days;
Meet the diagnosis of abnormal uterine bleeding and agree to be admitted for treatment. Assessed by the alkaline hemoglobin method, in 2 consecutive menstrual cycles during the screening period, the menstrual blood loss is >80 ml in both cycles; or the blood loss in any one cycle is ≥160 ml;
Patients with known endometrial polyps > 1.5 cm, endometrial malignancy, or atypical hyperplasia;
Patients with known or investigator-determined ovulatory dysfunctional abnormal uterine bleeding who require hormonal therapy;
Patients identified by investigators as having iatrogenic abnormal uterine bleeding;
Patients with abnormal uterine bleeding related to coagulation dysfunction, including but not limited to those with laboratory test results showing: platelet count ≤ 100×10⁹/L, or APTT prolonged by ≥ 10s beyond the upper limit of normal, or PT prolonged by ≥ 3s beyond the upper limit of normal;