Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BT-114143 Injection in Healthy Subjects

NCT07169240 | Completed Phase 1 DMC

• 1 other identifier: BT-114143-I-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, randomized, double-blind, placebo-controlled, single dose escalation design to evaluate the safety, tolerability, and pharmacokinetic characteristics of BT-114143 Injection.

Conditions

Healthy Subjects (HS)

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of BT-114143

  The number of Treatment-Emergent Adverse Events (TEAEs) with a severity of Grade 2 or higher in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  For single administration, the follow-up will last until Day 15 after dosing; for multiple administrations, the follow-up will last until Day 21 after dosing.

Secondary Outcomes (13)

• Cmax

  15 days after administration

• AUC

  15 days after administration

• t1/2

  15 days after administration

• CL

  15 days after administration

• Vz

  15 days after administration

Study Arms (12)

Dose level S-2

EXPERIMENTAL

Drug: BT-114143

Dose level S-1

EXPERIMENTAL

Drug: BT-114143

Dose level S1

EXPERIMENTAL

Drug: BT-114143

Dose level S2

EXPERIMENTAL

Drug: BT-114143

Dose level S3

EXPERIMENTAL

Drug: BT-114143

Dose level S4

EXPERIMENTAL

Drug: BT-114143

Dose level S5

EXPERIMENTAL

Drug: BT-114143

Dose level S6

EXPERIMENTAL

Drug: BT-114143

Dose level S7

EXPERIMENTAL

Drug: BT-114143

Dose level S8

EXPERIMENTAL

Drug: BT-114143

Dose level S9

EXPERIMENTAL

Drug: BT-114143

control group

PLACEBO COMPARATOR

Drug: 0.9% Sodium Chloride Injection as Placebo

Interventions

BT-114143 DRUG

6 subjects will receive a single dose of BT-114143 injection at 0.03 mg/kg.

Dose level S-1

0.9% Sodium Chloride Injection as Placebo DRUG

Except that the S1 dose group was a pilot study group with 1 subject matched to receive a placebo, all other dose groups were each matched with 2 subjects who received placebo treatment as controls.

control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects have been informed of the details of this study before the trial, have signed a written informed consent form, and voluntarily participate in the study;
• Healthy female or male subjects aged 18-55 years (inclusive) at the time of screening;
• Male subjects with a body weight of ≥50.0 kg and female subjects with a body weight of ≥45.0 kg; body mass index (BMI) ranging from 18.5 to 28 kg/m² (inclusive) \[BMI = weight (kg) / height² (m²)\];
• No history of abnormal eye color vision, or diseases related to the heart, liver, kidney, digestive system, nervous system, mental disorders, metabolic disorders, or blood system; those whose evaluations in terms of medical history, physical examination, vital signs, chest X-ray (posteroanterior), abdominal color Doppler ultrasound, ECG, and laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, etc.) are normal or show mild abnormalities with no clinical significance, and are deemed eligible by the researcher.

You may not qualify if:

• Confirmed as COVID-19 patients or asymptomatic infected persons upon inquiry;
• Subjects who have undergone major surgery within 6 months prior to screening, or plan to undergo surgery during the study, as well as those who have previously undergone surgeries that may affect drug absorption, distribution, metabolism, or excretion (excluding appendectomy);
• Subjects with a history of or persistent arterial or venous thrombosis, or at high risk of thrombosis; those with a family history of hereditary coagulation or bleeding disorders;
• Subjects with a history of epilepsy;
• Female subjects with a history of recurrent spontaneous abortion;
• Subjects with positive hepatitis B surface antigen and/or hepatitis B e antigen, positive hepatitis C virus antibody, positive human immunodeficiency virus antibody, or positive treponema pallidum antibody;
• Subjects with a positive alcohol breath test or positive urine drug abuse screening;
• Heavy drinkers, i.e., consuming more than 14 standard units of alcohol per week within 3 months prior to screening (1 standard unit contains 14 g of alcohol, such as 360 mL of beer, 45 mL of spirits with 40% alcohol content, or 150 mL of wine);
• Subjects with a history of drug abuse (e.g., morphine, tetrahydrocannabinolic acid, methamphetamine, 3,4-methylenedioxymethamphetamine, ketamine) within 1 year prior to the trial;
• Subjects who need to take non-steroidal anti-inflammatory drugs, TXA, or blood-activating Chinese medicines (such as Panax notoginseng, Ligusticum chuanxiong, Salvia miltiorrhiza, etc.) within 1 month prior to enrollment or during the enrollment period;
• Pregnant or lactating women, or those with positive blood pregnancy test results, as well as subjects who do not agree to take effective contraceptive measures from the signing of the informed consent form until 3 months after the end of the study (see Appendix 10.1.7);
• Subjects who participated in other clinical trials and used investigational drugs within 3 months prior to the trial;
• Subjects who donated blood or lost ≥400 mL of blood within 3 months prior to the trial, or plan to donate blood or have blood components drawn during the study;
• Subjects with artificial materials in the body, such as heart valves, implants, etc., which are judged by the researcher as unsuitable for enrollment;
• Subjects with contraindications or potential risk factors for the use of TXA, including those known to be sensitive to TXA;

Sponsors & Collaborators

• ScinnoHub Pharmaceutical Co., Ltd.: lead
• Peking University Care Luzhong Hospital: collaborator

Study Sites (1)

PKU Care Luzhong Hospital

Zibo, Shandong, 255499, China

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

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 17, 2025
• First Posted: September 11, 2025
• Study Start: February 6, 2023
• Primary Completion: April 17, 2024
• Study Completion: August 2, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)