NCT04627155已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Human Tolerance and Kinetics of LY03003 By Single Intramuscular Injection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Plasma drug concentration
研究概览
简要总结
This study is to evaluate the human tolerance and pharmacokinetics of LY03003.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18 to 45 years, no less than one-third of a single sex ratio;
- •normal physical examination items (including general physical examination, blood and urine, blood biochemistry, anti-HBV, anti-HCV, anti-HIV, pregnancy test, ECG, chest X-ray);
- •body weight not less than 50 kg, body mass index between 19 and 24 kg/m2;
- •during 2 weeks not using any drugs;
- •no history of drug allergy or drug allergy;
- •voluntarily participate in this clinical trial, can cooperate to complete the specified examinations, and sign the informed consent form
排除标准
- •abnormal health examination and clinical significance;
- •history of allergy to non-ergot dopamine agonists, or history of allergy to other drugs and food;
- •Bronchial asthma, epilepsy, mechanical intestinal obstruction, urinary tract obstruction;
- •history of liver and kidney disease, cardiovascular system, respiratory system, hematopoietic system, nervous and mental illness;
- •Women of childbearing age who have a positive pregnancy test or a negative pregnancy test but cannot ensure to take appropriate contraceptive measures during the study;
- •lactating women;
- •Male subjects who are unwilling to take appropriate contraceptive measures. Appropriate measures include the use of condoms, spermicides, or female partners using intrauterine devices (IUDs), ovarian caps, oral contraceptives, injected or subcutaneously implanted progestins, and tubal ligation surgery. Female partners must not be pregnant or lactating women;
- •smokers, alcoholics and drug abusers;
- •drinkers within 24 hours before medication;
- •used any drugs within 2 weeks before the trial; Use of drugs with effect on liver and kidney function within 11.3 months; Participated in other drug trials within 12.3 months, donated blood loss (≥ 200ml), or sampled as subjects;
- •Researchers believe that the participants are not suitable.
研究组 & 干预措施
7mg dose group
Experimental
干预措施: LY03003 (Drug)
14mg dose group
Experimental
干预措施: LY03003 (Drug)
结局指标
主要结局
Plasma drug concentration
时间窗: Hour1 、Hour6、Hour12、Hour24、Hour36、Hour48、Hour60 、Hour72 、Hour84、Hour96 、Hour120 、Hour144 、Day8、Day9、Day10、Day11、Day12、Day13、Day14、Day16、Day18 and Day 21after injection
Cmax
次要结局
- Vital signs(Hour1 、Hour6、Hour12、Hour24、Hour36、Hour48、Hour60 、Hour72 、Hour84、Hour96 、Hour120 、Hour144 、Day8、Day9、Day10、Day11、Day12、Day13、Day14、Day16、Day18 and Day 21after injection)
研究者
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