NCT07169240已完成1 期
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BT-114143 Injection in Healthy Subjects
ScinnoHub Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年2月6日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Safety and tolerability of BT-114143
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dose level S-2
Experimental
干预措施: BT-114143 (Drug)
Dose level S-1
Experimental
干预措施: BT-114143 (Drug)
Dose level S1
Experimental
干预措施: BT-114143 (Drug)
Dose level S2
Experimental
干预措施: BT-114143 (Drug)
Dose level S3
Experimental
干预措施: BT-114143 (Drug)
Dose level S4
Experimental
干预措施: BT-114143 (Drug)
Dose level S5
Experimental
干预措施: BT-114143 (Drug)
Dose level S6
Experimental
干预措施: BT-114143 (Drug)
Dose level S7
Experimental
干预措施: BT-114143 (Drug)
Dose level S8
Experimental
干预措施: BT-114143 (Drug)
Dose level S9
Experimental
干预措施: BT-114143 (Drug)
control group
Placebo Comparator
干预措施: 0.9% Sodium Chloride Injection as Placebo (Drug)
结局指标
主要结局
Safety and tolerability of BT-114143
时间窗: 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.
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.
次要结局
- Cmax(15 days after administration)
- Prothrombin Time（PT）(15 days after administration)
- Changes in Plasminogen Activity Results from Baseline(72 hours after administration)
- Changes in Thromboelastography (TEG) Parameters(72 hours after administration)
- AUC(15 days after administration)
- t1/2(15 days after administration)
- CL(15 days after administration)
- Vz(15 days after administration)
- Activated Partial Thromboplastin Time（APTT）(15 days after administration)
- International Normalized Ratio（INR）(15 days after administration)
- Fibrinogen（FIB）(15 days after administration)
- Thrombin Time（TT）(15 days after administration)
- D-Dimer(15 days after administration)
研究者
研究点 (1)
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