NCT07123428已完成1 期
A Phase I Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of and Food Effect on TRD205 After Single and Multiple Doses in Healthy Adult Subjects
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
- 151
- 试验地点
- 1
- 主要终点
- Treatment-Related Adverse Events
研究概览
简要总结
This is a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of TRD205 after single and multiple doses and to evaluate the effect of food on TRD205 in healthy adult subjects.
详细描述
This study consists of three parts:
- Single ascending dose study
- Multiple ascending dose study
- Food effect study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
The investigator and participant will be masked for the single ascending dose (SAD) study It's open label for multiple ascending dose (MAD) study and group B of food effect study.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who can understand the requirements and potential side effects of the study and voluntarily sign the informed consent form.
- •Able to complete the study per protocol and communicate with the investigators.
- •Subjects (and their sexual partners) should voluntarily practice effective contraception per protocol.
- •Healthy subjects aged 18-55 years.
- •Body weight should be ≥ 50 kg for male subjects and ≥ 45 kg for female subjects with a body mass index of 18-28 kg/m
- •Physical examination and vital sign: normal or are considered by the investigator to be of no clinical significance.
- •No vaccination within 30 days prior to screening.
排除标准
- •Smoking 5 or more cigarettes per day within 3 months before screening.
- •Subjects with an allergic constitution, such as a history of allergy to two or more drugs or food.
- •Subjects who have a history of drug abuse and or alcoholism.
- •Subjects who have had blood donation and/or blood loss ≥ 450 mL wihin 3 months before screening.
- •Subjects who have consumed medications known to alter hepatic drug metabolism enzyme activity within 28 days before screening.
- •Subjects who have taken any other prescription medication, OTC products, vitamins or herbal products within 14 days before screening, except for those exempted by the investigator on a case-by-case basis.
- •Subjects who have eaten special food, such as dragon fruit, mango, pomelo, grapefruit, cranberry and their juice, or had vigorous exercise, or had other factors that may influence the ADME process of drug.
- •Subjects who have concomitant drugs that induce or inhibit CYP3A4, P-gp, Bcrp.
- •Subjects who have consumed investigational products or participated in drug clinical trials within 3 months before taking IP.
- •Subjects who have dysphagia or other gastrointestinal diseases that can influence drug adsorption.
- •Subjects who can not tolerate the standard meal (just for those who participate the food effect study).
- •12-lead ECG: abnormal results and considered by the investigator to be of clinical significance.
- •Pregnant or lactating women.
- •Laboratory tests: abnormal results and considered by the investigator to be of clinical significance. Or subjects with the diseases of gastrointestinal tract, kidney, liver, nervous system, blood system, endocrinal system, tumor, lung, immunity, mental system, cardiovascular system, cerebral vascular system within 12 months before screening.
- •Positive serological tests for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and treponema pallidum (TP) at screening.
- •Subjects who have had acute disease or concomitant drugs from screening to taking IP.
- •Subjects who have consumed chocolate, Caffeine-containing products or xanthine containing food (such as tea, coffee, colar) within 48 hours beforing taking IP.
- •Subjects who have consumed alcohol-containing products within 48 hours beforing taking IP.
- •Subjects who have a positive urine drug screening test result.
- •Subject who have received surgery within 4 weeks before taking IP.
- •Subject who are not ready to abstain from participation in any other clinical study for the duration of this study and for 30 days or more (as required by the investigator) after completion of the study.
- •Mental or physical disability.
- •Subject cannot tolerate venipuncture blood collection or has a history of sickness at the sight of blood and/or needle.
- •Any reason that, in the opinion of the Investigator, may prevent the subject from participating in the study.
- •Subjects who have the risk factors of torsade de pointes, or a family history of a first-degree relative with short QT syndrome, long QT syndrome, unexplained sudden death in youth, drowning, or sudden infant death syndrome.
- •Subjects with abnormal and clinically significant hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia as judged by the investigator.
研究组 & 干预措施
TRD205: Single ascending dose (SAD) study
Experimental
TRD205: oral, single ascending doses up to 7 doses levels.
干预措施: TRD205 (Drug)
Placebo: Single ascending dose (SAD) study
Placebo Comparator
Placebo: oral, TRD205 placebo in single ascending doses study.
干预措施: Placebo (Drug)
TRD205: Food effect study
Experimental
TRD205: oral, just 1 dose under fasted or fed condition for each period.
干预措施: TRD205 (Drug)
Placebo: Food effect study
Placebo Comparator
Placebo: oral, under fasted or fed condition for each period.
干预措施: Placebo (Drug)
Multiple ascending dose (MAD) study
Experimental
TRD205: oral, multiple ascending doses up to 4 doses levels. Doses and dosing frequency will be decided based on SAD results.
干预措施: TRD205 (Drug)
结局指标
主要结局
Treatment-Related Adverse Events
时间窗: After a single dose and/or once daily for 10 consecutive doses
The safety and tolerability of TRD205 orally administered once and/or multiple times on an empty stomach in healthy subjects
次要结局
- Area under the plasma concentration versus time curve （AUC）(After a single dose and/or once daily for 10 consecutive doses)
- Peak Plasma Concentration（Cmax）(After a single dose and/or once daily for 10 consecutive doses)
- apparent volume of distribution（Vd）(After a single dose and/or once daily for 10 consecutive doses)
- time to peak（Tmax）(After a single dose and/or once daily for 10 consecutive doses)
- Elimination rate constant（Kel）(After a single dose and/or once daily for 10 consecutive doses)
- elimination half life（T1/2）(After a single dose and/or once daily for 10 consecutive doses)
- Mean retention time（MRT）(After a single dose and/or once daily for 10 consecutive doses)
研究者
研究点 (1)
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