A Randomized, Double-blind, Placebo-controlled, Dose-increasing Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Infusion of LPM3480392 Injection in Healthy Subject
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- DEQ
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, dose-increasing Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single intravenous infusion of LPM3480392 injection in healthy subject
详细描述
A total of 80 healthy subjects will be allocated to 1 of 8 cohorts (cohort 1~8) in the study, each cohort including 10 subjects (8 subjects will receive investigational new drug (IND) product and 2 receive placebo). Each subject in fasted state will be randomly assigned to receive a single dose of LPM3480392 or placebo intravenously.
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
- 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℃ (± 0.2℃) 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 drug 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
LPM3480392 X4mg
8 subjects will receive LPM3480392 X4mg and 2 receive placebo
干预措施: Placebo (Drug)
LPM3480392 X1mg
8 subjects will receive LPM3480392 X1mg and 2 receive placebo
干预措施: LPM3480392 (Drug)
LPM3480392 X1mg
8 subjects will receive LPM3480392 X1mg and 2 receive placebo
干预措施: Placebo (Drug)
LPM3480392 X2mg
8 subjects will receive LPM3480392 X2 mg and 2 receive placebo
干预措施: LPM3480392 (Drug)
LPM3480392 X2mg
8 subjects will receive LPM3480392 X2 mg and 2 receive placebo
干预措施: Placebo (Drug)
LPM3480392 X3mg
8 subjects will receive LPM3480392 X3mg and 2 receive placebo
干预措施: LPM3480392 (Drug)
LPM3480392 X3mg
8 subjects will receive LPM3480392 X3mg and 2 receive placebo
干预措施: Placebo (Drug)
LPM3480392 X4mg
8 subjects will receive LPM3480392 X4mg and 2 receive placebo
干预措施: LPM3480392 (Drug)
LPM3480392 X5mg
8 subjects will receive LPM3480392 X5mg and 2 receive placebo
干预措施: LPM3480392 (Drug)
LPM3480392 X5mg
8 subjects will receive LPM3480392 X5mg and 2 receive placebo
干预措施: Placebo (Drug)
LPM3480392 X6mg
8 subjects will receive LPM3480392 X6mg and 2 receive placebo
干预措施: LPM3480392 (Drug)
LPM3480392 X6mg
8 subjects will receive LPM3480392 X6mg and 2 receive placebo
干预措施: Placebo (Drug)
LPM3480392 X7mg
8 subjects will receive LPM3480392 X7mg and 2 receive placebo
干预措施: LPM3480392 (Drug)
LPM3480392 X7mg
8 subjects will receive LPM3480392 X7mg and 2 receive placebo
干预措施: Placebo (Drug)
LPM3480392 X8mg
8 subjects will receive LPM3480392 X8mg and 2 receive placebo
干预措施: LPM3480392 (Drug)
LPM3480392 X8mg
8 subjects will receive LPM3480392 X8mg and 2 receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
DEQ
时间窗: from baseline to day2
Drug effect questionnaire,
Incidents of AE (including SAE)
时间窗: from baseline to day8
(including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG)
OWS
时间窗: from baseline to day3
Opiate Withdrawal Scale
次要结局
- Vd(baseline and 48 hours after administration)
- MRT(baseline and 48 hours after administration)
- λz(baseline and 48 hours after administration)
- Cmax(baseline and 48 hours after administration)
- Tmax(baseline and 48 hours after administration)
- T1/2(baseline and 48 hours after administration)
- PD profile : Cold Pain Test(baseline and 8 hours after administration)
- PD profile : Pupillometry(baseline and 8 hours after administration)
- AUC0-t(baseline and 48 hours after administration)
- AUC0-∞(baseline and 48 hours after administration)
- CL(baseline and 48 hours after administration)