NCT07230652招募中1 期
A Randomized, Double-Blind, Placebo-Controlled, Dose- Ascending Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Chinese Adult Healthy Subjects and/or Subjects With Stable Schizophrenia
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events (AEs) and serious adverse events (SAEs).
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, ascending multiple oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects and/or subjects with stable schizophrenia.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects
- •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 body mass index (BMI) between 18.5 and 26.0 kg/m2 Subjects with Stable Schizophrenia
- •Subjects themselves and / or their guardians sign informed consent voluntarily.
- •Male or female aged 18 to 60 years.
- •Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 32.0 kg/m
- •Subject must meet the DSM-V criteria for a primary diagnosis of schizophrenia. Subject must have a PANSS total score ≤ 80 and CGI-S score ≤ 4 at screening. The condition is stable from 1 month before signing informed consent to baseline.
排除标准
- •Healthy Subjects
- •Subjects have any clinically significant medical condition or chronic disease.
- •Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
- •Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.
- •Subjects with a history of orthostatic hypotension or syncope.
- •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 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 antibody. Subjects with Stable Schizophrenia
- •According to the DSM-5, there were other mental disorders except schizophrenia within 6 months before screening period.
- •Assessed by the investigator as having treatment-resistant schizophrenia; past or current diagnosis of neuroleptic malignant syndrome (NMS); anticipated need for antipsychotic regimen modifications during the study period;
- •History of suicide attempts (including actual attempts, interrupted attempts, or failed attempts) or suicidal ideation within the past 6 months, defined as affirmative responses ("yes") to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening/baseline;
- •Subjects have used monoamine oxidase inhibitors (MAOI) within 28 days or any dietary supplements/traditional Chinese herbal products within 7 days prior to first dosing.
- •Glycated hemoglobin (HbA1c) ≥7% at screening/baseline.
- •Congenital long QT syndrome; uncontrolled or severe cardiovascular disease, including NYHA class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to screening, or presence of treatment-requiring severe arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) at screening; resting heart rate <50 beats per minute (bpm) at screening/baseline; or QTc >450 ms (male) / QTc >460 ms (female) based on Fridericia's formula-corrected measurements at screening/baseline.
- •Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.
- •Subjects with a history of orthostatic hypotension or syncope.
研究组 & 干预措施
LY03020
Experimental
Subjects will take LY03020 from Day 1 to Day 7
干预措施: LY03020 (Drug)
Placebo
Placebo Comparator
Subjects will take Placebo from Day 1 to Day 7
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
时间窗: up to Day 11
次要结局
- Maximum observed concentration at steady state (Cmax,ss) of LPM787000048 in plasma(up to Day 11)
- Area under the concentration-time curve from time zero extrapolated to infinity at steady state (AUC0-∞,ss) of LPM787000048 in plasma(up to Day 11)
- AUC Accumulation Ratio (Ra(AUC)) of LPM787000048 in plasma(up to Day 11)
- Number of participants with ophthalmic examination abnormalities.(up to Day 11)
- Number of participants with clinical laboratory assessment abnormalities.(up to Day 11)
- Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS) at Day 11 of subjects with stable schizophrenia(up to Day 11)
- Minimum observed concentration at steady state (Cmin,ss) of LPM787000048 in plasma(up to Day 11)
- Time to maximum observed concentration at steady (Tmax,ss) state of LPM787000048 in plasma(up to Day 11)
- Change from Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 11 of subjects with stable schizophrenia(up to Day 11)
- Change from Baseline in Barnes Akathisia Rating Scale (BARS) at Day4 and Day 11 of subjects with stable schizophrenia(up to Day 11)
- Change from Baseline in Simpson-Angus Scale (SAS) at Day4 and Day 11 of subjects with stable schizophrenia(up to Day 11)
- Area under the concentration- time curve during the dosing interval at steady state (AUC0-τ,ss) of LPM787000048 in plasma(up to Day 11)
- Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma(up to Day 11)
- Number of participants with vital sign abnormalities.(up to Day 11)
- Number of participants with 12-lead electrocardiogram abnormalities (ECGs).(up to Day 11)
- Cmax Accumulation Ratio (Ra(Cmax)) of LPM787000048 in plasma(up to Day 11)
研究者
研究点 (1)
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