drugset / Trial / NCT07169214
Evaluation of Safety, Efficacy, and Pharmacokinetics of BT-114143 Injection in Patients With Abnormal Uterine Bleeding
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BT-114143 | Unknown | — | — |
Indications
No indication recorded.