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RECRUITING
NCT07169214
PHASE1

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

Sponsor: ScinnoHub Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2024-10-30

Completion Date

2025-12-31

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DRUG

BT-114143 Injection at low dose

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.

DRUG

BT-114143 Injection at Medium-dose

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.

DRUG

BT-114143 Injection at High-dose

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.

DRUG

control group

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)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China