A Phase Ⅰ, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Study to Assess the Safety, Tolerability, and Pharmacokinetics of LPM787000048 Maleate Sustained-release Tablet (LY03020) in Chinese Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Frequency of adverse events (AEs)
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects.
详细描述
The study will set 2.5mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg and 100mg, a total of 8 dose groups. Qualified subjects were enrolled in site at D-1 ( 1 day before administration ) and randomized.The subjects should fast for at least 10 hours before medication administration, with no restrictions on water intake. The subjects will be required to orally take LY03020 or a placebo on an empty stomach upon waking on D1 (the day of medication administration). From D1 to D7, they will undergo safety assessments and PK biological sample collection.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects sign informed consent voluntarily.
- •Male or female aged 18 to 45 years.
- •Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and male or female greater than or equal to 18.5 but less than 26.0 kg/m2 of body mass index (BMI).
排除标准
- •Subjects have any clinically significant medical condition or chronic disease.
- •Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure,or angle-closure glaucoma.Subjects have a abnormal and clinically significant test for ophthalmic examination during screening.
- •Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.
- •Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.
- •Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.
- •Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
- •Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation
- •Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis serum reaction.
研究组 & 干预措施
LY03020
Subjects will take single-dose LY03020 on Day 1
干预措施: LY03020 (Drug)
Placebo
Subjects will take single-dose Placebo on Day 1
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of adverse events (AEs)
时间窗: up to144 hours
Percentage of adverse events
次要结局
- Time to maximum observed concentration (Tmax) of LPM787000048 in plasma(up to144 hours)
- Maximum observed concentration (Cmax) of LPM787000048 in plasma(up to144 hours)
- Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma(up to144 hours)
- Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma(up to144 hours)
- Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma(up to144 hours)
- Apparent volume of distribution（Vz/F） of LPM787000048 in plasma(up to144 hours)
- Apparent total body clearance (CL/F) of LPM787000048 from plasma(up to144 hours)