NCT07371065Enrolling By Invitation1 期
A Randomized, Double-blind, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, be Consistency and Food Effects of LY03021 Tablets in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Adverse Event
研究概览
简要总结
This is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the treatment of Chinese patients with depression.
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
- •Those who voluntarily participate in and sign the informed consent form after understanding the purpose, content, process and possible risks of the trial;
- •Healthy male/female volunteers between 18 and 45 years of age, inclusive, at the time of signing the informed consent form;
- •Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 kg/m2~ 28.0 kg/m2 (including the boundary value) at screening;
- •Be able to communicate well with the Investigator and comply with the lifestyle restrictions specified in the protocol and various requirements of the clinical trial (scheduled visits, laboratory tests and other trial procedures).
排除标准
- •Known to have a history of allergy to any component of the Investigational product or similar drugs, or allergic constitution (previous allergy to two or more foods or drugs);
- •The subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to a past or present respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry, dermatology and any other clinically significant disease or chronic disease; or any other disease that may interfere with the test results;
- •Any surgical conditions or conditions that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a risk to the subjects participating in the trial, including a history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding, etc.;
- •Subjects with current or past mental disorders and brain dysfunction, or at risk of suicide according to Columbia-Suicide Severity Rating Scale (C-SSRS), or having a suicide risk at the discretion of the Investigator, , or with a history of self-mutilation;
- •History of substance abuse or positive result in urine drug screening within 1 year prior to dosing;
- •History of alcohol abuse (defined as more than 14 standard units of alcohol per week, 1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine) or positive breath test results within 1 year before dosing;
- •Subjects who have a history of surgery within 3 months before dose administration, or have not recovered from surgery, or have an anticipated surgical planning during the trial;
- •Those who have participated in other clinical trials within 3 months before dose administration (including drug and medical device clinical trials, the time is based upon the last visit);
- •Blood donation or blood loss ≥ 400 mL within 3 months before dose administration, or blood donation or blood loss ≥ 200 mL within one month, or having a history of using blood products;
- •Pregnant and lactating women; and those who refuse to take effective contraception measures (such as abstinence, intrauterine device or condom with intravaginal spermicide, etc.) during the study period and within 28 days after the end of the study, or have the plan to donate sperm or eggs;
- •Abnormalities in vital signs, laboratory tests and 12-lead electrocardiogram (ECG) , and clinically significant as judged by the Investigator, for example:
- •QTc > 450 ms for males and > 460 ms for females, Friericia's correction; Resting pulse rate < 55 beats/min or > 100 beats/min; systolic blood pressure < 90 mmHg or ≥ 140 mmHg; diastolic blood pressure < 60 mmHg or ≥ 90 mmHg;
- •Use of the following medications or treatments prior to dosing:
- •Use of any prescription medication within 28 days prior to dosing; Use of any over-the-counter medications, including health products, within 7 days prior to dosing;
- •Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), syphilis serum reaction (Trust) non-negative;
- •The average daily smoking of ≥ 5 cigarettes within 3 months before dose administration;
- •Those who have special requirements for food and cannot abide by the unified diet or have dysphagia;
- •Consumption of food or beverages containing grapefruit and/or pomelo within 7 days prior to dosing;
- •Consumption of xanthine-rich foods or beverages (such as tea, coffee, cola or chocolate) within 3 days before dose administration;
- •Poor compliance or any condition that is considered as unsuitable for the study participation by the Investigator.
研究组 & 干预措施
LY03021 group
Experimental
Orally only once
干预措施: LY03021 (Drug)
Placebo
Sham Comparator
Orally only once
干预措施: placebo (Drug)
结局指标
主要结局
Adverse Event
时间窗: Day 12
次要结局
- PK parameters: Cmax(Day 12)
- PK parameters: Tmax(Day 12)
研究者
研究点 (1)
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