Phase 1 Study of BT-114143 Injection for Treating Abnormal Uterine Bleeding in Women Aged 18 to 50

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and how the body processes multiple doses of BT-114143 Injection in adult women with abnormal uterine bleeding AUB. This Phase Ib, randomized, double-blind, placebo-controlled study also explores changes in blood clotting markers and quality of life. The study plans to enroll 39 premenopausal women aged 18 to 50 years with diagnosed abnormal uterine bleeding. Participants are divided into four groups receiving either low, medium, or high doses of BT-114143 Injection or a placebo normal saline. Each treatment is given twice daily for three consecutive days. The ratio of experimental to control subjects is 103 for each dose group. This multiple-dose escalation design helps assess different dose levels of the study drug. During the study, researchers will monitor participants from the first administration until two weeks after the last dose for safety. They will measure changes in menstrual bleeding volume, number of bleeding days, and quality of life using specific questionnaires. Participants will undergo tests to evaluate blood clotting, pregnancy status, and other health indicators. The total participation time includes screening, treatment, and follow-up periods ending December 31, 2025.

Evaluation of Safety, Efficacy, and Pharmacokinetics of BT-114143 Injection in Patients With Abnormal Uterine Bleeding