NCT05238701已完成1 期
A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 Sustained-release Tablets in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse effects
研究概览
简要总结
This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for subsequent clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject who voluntarily participate and sign the informed consent form;
- •Healthy male/female volunteers aged 18 to 45 years;
- •Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 ~ 28.0 kg/m2, inclusive;
- •Able to comply with the lifestyle restrictions.
排除标准
- •Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
- •Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results;
- •Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects;.
- •Subject has a history of self-mutilation; or at risk of suicide;
- •Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial;
- •Subject has abnormal vital signs, laboratory abnormalities, and ECGs;
- •Subject has used any of over-the-counter products within 14 days or prescription medications within 28 days prior to dosing;
- •Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust);
- •Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results;
- •Subject has a history of substance abuse or a positive urine drug screen;
- •Subject who has daily smoking of ≥ 5 cigarettes;
- •Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
- •Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
- •Subject who has participated in other clinical trials within 3 months before administration;
- •Subject has used blood products or being blood donor or blood loss;
- •Pregnant, lactating women, or positive pregnancy test;
- •Subject who refusal to contraception, or plan to donate sperm or ovums;
- •Other conditions which would make participation in the study unsuitable.
研究组 & 干预措施
LPM3770164
Experimental
LPM3770164 sustained-release tablets will be administrated with single dose from 0.5mg to 60mg
干预措施: LPM3770164 sustained release tablet (Drug)
Placebo
Placebo Comparator
LPM3770164 sustained release tablet simulant will be administrated with single dose
干预措施: LPM3770164 sustained release tablet simulant (Drug)
结局指标
主要结局
Treatment-emergent adverse effects
时间窗: from baseline to day 28
Number of participants with treatment-emergent adverse effects will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
次要结局
- Stanford Sleepiness Scale (SSS)(baseline, day 3, day 28)
- Clearance (CL)(from baseline to day 15)
- Mean Residence Time (MRT)(from baseline to day 15)
- Haematology(baseline, day 3, day 8, day 15, day 28)
- Time to maximum observed concentration (Tmax)(from baseline to day 15)
- Blood Chemistry(baseline, day 3, day 8, day 15, day 28)
- Barnes Akathisia Rating Scale (BARS)(baseline, day 3, day 28)
- Abnormal Involuntary Movement Scale (AIMS)(baseline, day 3, day 28)
- Body Temperature(baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28)
- Respiratory Rate(baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28)
- Physical Examination(baseline, day 15, day 28)
- Area under the concentration-time curve (AUC)(from baseline to day 15)
- Coagulation(baseline, day 15, day 28)
- Blood Pressure(baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28)
- Maximum observed concentration (Cmax)(from baseline to day 15)
- Half-life (t1/2)(from baseline to day 15)
- Urinalysis(baseline, day 15, day 28)
- Pulse Rate(baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28)
- 12 lead electrocardiogram corrected QT interval(baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28)
- Simpson-Angus Rating Scale (SAS)(baseline, day 3, day 28)
研究者
研究点 (1)
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