To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LPM3480392 Injection at Different Rates in Healthy Subjects in a Phase I Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Incidents of AE (including SAE)
研究概览
简要总结
This study evaluated the safety, tolerability and PK/PD characteristics of LPM3480392 injection by intravenous infusion at different rates in healthy subjects.The experiment was divided into Part A and Part B.
Part A is a open label ,three cycle , fixed sequence dosing study .Twelve healthy male subjects were planned to be enrolled, and the same dose (X1mg)of LPM3480392 injection was intravenously injected at different infusion times in different drug administration cycles.
Part B is an open label ,two cycle , fixed sequence dosing study .Ten healthy male subjects (subjects not enrolled in Part A) were given LPM3480392 injection in 2 minutes , each subject was given X2mg at the first cycle and X3mg at the second cycle .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The subject voluntarily signs the informed consent.
- •Healthy male, aged 18-45 years (including boundary values);
- •Body mass index (BMI) 19-26kg/m2 (including boundary value), weight ≥50kg;
- •Subjects are willing to take contraceptive measures and promise not to donate sperm during the study period and within 90 days after administration;
- •Willing to accept cold pain test, and the non-dominant hand can be soaked in ice water bath at 2℃ (± 0.3℃) for > 10s, < 120s;
排除标准
- •Known history of allergy to any component of the investigational product or similar drugs, or allergic constitution [subjects with previous allergy to two or more foods or drugs];
- •Past or present with any clinically significant disease or chronic disease of the respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, hematology, psychiatry, dermatology, orthostatic hypotension, etc.; or any disease that may interfere with the test results or interpretation of the results;
- •Patients with Raynaud's syndrome;
- •The skin wounds or skin diseases that may affect the cold pain test results; Sitting systolic blood pressure (SBP) < 90 mmHg, ≥ 140 mmHg or diastolic blood pressure (DBP) < 60 mmHg, ≥ 90 mmHg; subjects with heart rate < 60 beats/min, > 100 beats/min;
- •QTc > 450 ms on electrocardiogram;
- •Positive urine nicotine test;
- •History of alcohol abuse within 3 months prior to Screening, defined as consumption of more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of spirits of 40% alcohol content, or 150 mL of wine), or a positive breath alcohol result;
- •History of substance abuse or drug abuse or positive result of urine drug screening;
- •Those who consume more than 100 g of xanthine-rich foods such as chocolate per day on average; those who consume more than 100 g of foods containing grapefruit and/or pomelo; those who consume more than 1000 mL of strong tea, coffee, cola and beverages containing caffeine and/or grapefruit ingredients;
研究组 & 干预措施
Part A
Each subject receive the same dose(X1mg) of LPM3480392 in 15minutes in the first cycle, 5 minutes in the second cycle, and 2 minutes in the third cycle .
干预措施: LPM3480392 (Drug)
Part B
Each subject receive LPM3480392 X2mg in the first cycle and LPM3480392 X3mg in the second cycle .
干预措施: LPM3480392 (Drug)
结局指标
主要结局
Incidents of AE (including SAE)
时间窗: from baseline to day7 of second or third cycle(each cycle is 4 days)
including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG
OWS scores
时间窗: from baseline to day7 of second or third cycle(each cycle is 4 days)
Opiate Withdrawal Scale
DEQ scores
时间窗: from baseline to day2 of second or third cycle(each cycle is 4 days)
Drug effect questionnaire
次要结局
- AUC0-∞(baseline and within 24 hours after administration)
- Tmax(baseline and within 24 hours after administration)
- T1/2(baseline and within 24 hours after administration)
- CL(baseline and within24 hours after administration)
- Vd(baseline and within 24 hours after administration)
- MRT(baseline and within 24 hours after administration)
- λz(baseline and within 24 hours after administration)
- Cold Pain Test(baseline and within 8 hours after administration)
- Pupillometry(baseline and within 8 hours after administration)
- Cmax(baseline and within 24hours after administration)
- AUC0-t(baseline and within 24 hours after administration)