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

NCT07169214 | Recruiting Phase 1

• 1 other identifier: BT-114143-I-02
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

• safety evaluation

  The incidence of abnormal laboratory values, clinically significant physical examination findings, vital signs, electrocardiograms (ECGs), and/or treatment-related adverse events/serious adverse events.

  from the first administration to 2 weeks after the last administration

Secondary Outcomes (8)

• Change of menstrual bleeding volume from baseline

  from signing the informed consent to 2 weeks after the last administration

• Percentage change of menstrual bleeding volume from baseline

  from signing the informed consent to 2 weeks after the last administration

• The difference in the number of menstrual bleeding days between the post-treatment period and the baseline period in subjects.

  From signing the informed consent to 2 weeks after the last administration

• The proportion of subjects with menstrual blood loss ≤ 80 ml after treatment.

  from signing the informed consent to 2 weeks after the last administration

• The proportion of subjects with a reduction in menstrual blood loss of ≥50 ml after treatment compared with the baseline

  from signing the informed consent to 2 weeks after the last administration

Other Outcomes (9)

• To characterize the pharmacokinetic (PK) profile of BT-114143

  Three days after administration

• Changes in Plasminogen Activity Results from Baseline

  Three days after administration

• Prothrombin Time（PT）

  Three days after administration

Study Arms (4)

low-dose group

EXPERIMENTAL

Subjects received low-dose BT-114143 Injection treatment

Drug: BT-114143 Injection at low dose

Medium-dose group

EXPERIMENTAL

Subjects received Medium-dose BT-114143 Injection treatment

Drug: BT-114143 Injection at Medium-dose

High-dose Group

EXPERIMENTAL

Subjects received High-dose BT-114143 Injection treatment

Drug: BT-114143 Injection at High-dose

control group

PLACEBO COMPARATOR

The subjects receive normal saline treatment.

Drug: control group

Interventions

BT-114143 Injection at low dose DRUG

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.

low-dose group

BT-114143 Injection at Medium-dose DRUG

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.

Medium-dose group

BT-114143 Injection at High-dose DRUG

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.

High-dose Group

control group DRUG

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.

control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be able to sign the informed consent form before any study-related procedures are performed, and be willing and able to comply with the study requirements;
• Premenopausal female subjects, aged 18-50 years, including 18 and 50 years;
• Have regular menstrual cycles in the past 6 months, with a menstrual cycle of ≥21 days and ≤35 days, and a menstrual period duration of ≤14 days;
• Meet the diagnosis of abnormal uterine bleeding and agree to be admitted for treatment. Assessed by the alkaline hemoglobin method, in 2 consecutive menstrual cycles during the screening period, the menstrual blood loss is \>80 ml in both cycles; or the blood loss in any one cycle is ≥160 ml;
• The pregnancy test result is negative before randomization;
• Those with a body mass index \[BMI = weight (kg) / height² (m²)\] of 18.5-28.0 kg/m² (including the boundary values).

You may not qualify if:

• Patients with known endometrial polyps \> 1.5 cm, endometrial malignancy, or atypical hyperplasia;
• Patients with known or investigator-determined ovulatory dysfunctional abnormal uterine bleeding who require hormonal therapy;
• Patients identified by investigators as having iatrogenic abnormal uterine bleeding;
• Patients with abnormal uterine bleeding related to coagulation dysfunction, including but not limited to those with laboratory test results showing: platelet count ≤ 100×10⁹/L, or APTT prolonged by ≥ 10s beyond the upper limit of normal, or PT prolonged by ≥ 3s beyond the upper limit of normal;
• Patients with bleeding caused by cervical or vaginal lesions;
• Patients who have undergone major surgery within 6 months prior to screening;
• Patients determined by investigators before randomization to require surgical treatments such as total hysterectomy, myomectomy, hysteroscopic treatment, uterine artery embolization, or ablation during the study period;
• Patients who have received the following medications within 3 months prior to randomization: gonadotropin-releasing hormone agonists; sex hormone drugs administered orally, by injection, vaginally, or transdermally (including but not limited to drugs containing estrogen or progesterone); selective estrogen receptor modulators; hormonal intrauterine devices (LNG-IUS). For long-acting (3-month) gonadotropin-releasing hormone agonists or progesterone preparations, the last administration must be no later than 6 months prior to randomization;
• Patients who have used danazol, desmopressin, tranexamic acid, aminocaproic acid, or traditional Chinese medicines for the treatment of menorrhagia within 3 months prior to randomization;
• Patients who need to receive anticoagulants (e.g., warfarin, heparin, etc.) or antiplatelet therapies (e.g., clopidogrel, ticagrelor, etc.) during the study period;
• Patients with intolerance or contraindications to BT-114143 Injection;
• Patients who have participated in clinical trials of other investigational drugs, biological agents, or medical devices and received therapeutic interventions within 30 days prior to screening;
• Patients with clinically severe diseases such as known disorders of the circulatory, endocrine, nervous, digestive, respiratory, urinary, hematological, immunological, psychiatric, or metabolic systems, as assessed by investigators as unsuitable for participation in the trial;
• Patients with a known history of glaucoma or retinopathy, as assessed by investigators as unsuitable for participation in the trial;
• Untreated or poorly controlled thyroid dysfunction, except for mild subclinical hypothyroidism (i.e., TSH \< 10 mIU/L with normal FT4 and TT4);

Sponsors & Collaborators

• ScinnoHub Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Metrorrhagia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 11, 2025
• Study Start: October 30, 2024
• Primary Completion: September 23, 2025
• Study Completion: December 31, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)