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

ScinnoHub Pharmaceutical Co., Ltd.

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects (HS)

Treatments: Drug: 0.9% Sodium Chloride Injection as Placebo; Drug: BT-114143

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07169240

BT-114143-I-001

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• Subjects who are judged by the researcher to have poor compliance, or have other factors that make them unsuitable for participating in this trial;
• Subjects who cannot complete the trial for other reasons.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 12 patient groups, including a placebo group

Dose level S-2

Experimental group

Treatment:

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Dose level S-1

Experimental group

Treatment:

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Dose level S1

Experimental group

Treatment:

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Dose level S2

Experimental group

Treatment:

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Dose level S3

Experimental group

Treatment:

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Dose level S4

Experimental group

Treatment:

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Dose level S5

Experimental group

Treatment:

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Dose level S6

Experimental group

Treatment:

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Dose level S7

Experimental group

Treatment:

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Dose level S8

Experimental group

Treatment:

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Dose level S9

Experimental group

Treatment:

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

Drug: BT-114143

control group

Placebo Comparator group

Treatment:

Drug: 0.9% Sodium Chloride Injection as Placebo