Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-05; most recent amendment 2025-12-12.
Trial Details
NCT Number NCT07169214
Lead Sponsor ScinnoHub Pharmaceutical Co., Ltd.
Conditions Abnormal Uterine Bleeding
Enrollment 39 participants
Start Date 2024-10-30
Primary Completion 2025-09-23 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-15