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;
Parallel
BT-114143 Injection at low dose
DrugA total of 10 subjects were enrolled. All of them received BT-114143 Injection at low dose. BT-114143 will be administered twice daily for three consecutive days.
BT-114143 Injection at Medium-dose
DrugA total of 10 subjects were enrolled. All of them received BT-114143 Injection at Medium-dose. BT-114143 will be administered twice daily for three consecutive days.
BT-114143 Injection at High-dose
DrugA total of 10 subjects were enrolled. All of them received BT-114143 Injection at High-dose. BT-114143 will be administered twice daily for three consecutive days.
control group
DrugThe ratio of subjects in the experimental group to those in the control group is 10:3, with 3 placebo - treated control subjects corresponding to each dose group. The subjects will receive placebo treatment twice a day for 3 consecutive days.
safety evaluation
The incidence of abnormal laboratory values, clinically significant physical examination findings, vital signs, electrocardiograms (ECGs), and/or treatment-related adverse events/serious adverse events.
Change of menstrual bleeding volume from baseline
Sanitary products used by subjects are collected regularly, and menstrual blood loss is measured by the alkaline hemoglobin method.
Percentage change of menstrual bleeding volume from baseline
Sanitary products used by subjects are collected regularly, and menstrual blood loss is measured by the alkaline hemoglobin method.
The difference in the number of menstrual bleeding days between the post-treatment period and the baseline period in subjects.
The proportion of subjects with menstrual blood loss ≤ 80 ml after treatment.
To characterize the pharmacokinetic (PK) profile of BT-114143
Plasma concentration of BT-114143 will be measured and following PK parameters will be characterized: Maximum observed concentration (Cmax); Time to Cmax (Tmax); area under the plasma concentration-time curve (AUC) from the time 0 to the last quantifiable time point (AUC0-t); AUC from the time 0 to infinity (AUC0-inf); half-life (t1/2); apparent clearance (CL/F); apparent volume of distribution (Vz/F)
Changes in Plasminogen Activity Results from Baseline
Blood samples will be collected to determine the changes in plasminogen activation over time.
Prothrombin Time（PT）
The change of PT from baseline
Activated Partial Thromboplastin Time（APTT）
The change in Activated Partial Thromboplastin Time (APTT) from baseline
Click on the lead sponsor to view all of their trials.
