Evaluation of Safety, Efficacy, and Pharmacokinetics of BT-114143 Injection in Patients With Abnormal Uterine Bleeding
ScinnoHub Pharmaceutical Co., Ltd.
39 participants
Oct 30, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
A 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.
A 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.
A 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.
The 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.
Locations(1)
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NCT07169214