drugset / Trial / NCT07169214

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

NCT07169214

Phase 1 Recruiting 39 enrolled ScinnoHub Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2024-10-30
Primary completion
2025-09-23
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject BT-114143 Unknown

Indications

No indication recorded.