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A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects

2021年4月7日 更新者:Jiangsu Nhwa Pharmaceutical Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of CY150112 After Single Oral Administration in Healthy Chinese Subjects

The primary objective of single ascending dose study is to evaluate the safety and tolerability of CY150112 after single oral administration of different doses in healthy Chinese subjects.

研究概览

详细说明

Single administration, double-blinded, placebo-controlled (2 subjects in each group will take placebo,8 subjects in each group will take CY150112) and 6 dose groups (0.5mg, 1.5mg, 4.5mg, 10mg, 18mg and 24mg).

This study comprises a screening period (between signing of the informed consent form and Day -1), baseline period (Day -1), treatment period (Days 1-5) and follow-up period(Days 12 or 7 days after discharge ).

研究类型

介入性

注册 (预期的)

60

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Hua Fang li, MD
  • 电话号码:021-34773107
  • 邮箱lhlh_5@163.com

研究联系人备份

  • 姓名:Li Yan, Research Doctor
  • 电话号码:021-34773107
  • 邮箱lhlh_5@163.com

学习地点

    • Shanghai
      • Shanghai、Shanghai、中国、200030
        • 招聘中
        • Shanghai Mental Health Center
        • 接触:
        • 接触:
          • Li Yan, Research Doctor
          • 电话号码:021-34773107
          • 邮箱lhlh_5@163.com
        • 首席研究员:
          • Hua Fang Li, MD
        • 副研究员:
          • Li Yan, Research Doctor

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Male/female subjects are 18<age ≤45 years of age when signing the informed consent.
  2. Male Subjects with body weight of ≥50.0kg ,and female Subjects with body weight of ≥45.0kg and BMI (body mass index) of 18.5≤ and <28.0 at screening examination.
  3. After detailed explanations of study objectives, contents and procedures, and possible risks, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily.
  4. Subjects are able to communicate well with researchers, be willing and able to comply with the lifestyle restrictions stipulated during this study period, and cooperate to complete this study.

Exclusion Criteria:

  1. The investigator determined that the subjects' present medical history and past medical history had any disease or dysfunction that would affect the clinical trial, including but not limited to diseases of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematological system, etc.
  2. There is any surgical condition or disease that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may harm to the subjects participating in the trial; such as history of gastrointestinal operations (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, digestive tract ulcers, history of gastrointestinal bleeding, etc.
  3. Subjects with past history of allergy to drugs or allergic disease.
  4. Subjects with currently or past history of mental disorders and brain functional disorders.
  5. According to the Columbia suicide severity scale (C-SSRS), subjects were at risk of suicide or were at risk of suicide based on the clinical judgment of the researchers, or with past history of self-injurious behavior.
  6. Subjects have history of drug abuse or positive urine drug tests at screening within 1 year prior.
  7. Subjects have history of alcohol abuse(i.e.,criteria are per week consumption more than 14 standard units(1 unit =360mL beer or 45mL 40% alcohol of Chinese liquor or 150mL wine)or positive alcohol breath tests at screening within 1 year prior.
  8. Average amount of daily smoking>5 cigarettes at screening 3 months prior.
  9. Those who have special requirements for food, cannot follow a uniform diet or have difficulty swallowing.
  10. Female subjects who are pregnant and lactating ; and those who refuse to use effective non-drug contraceptive measures (such as abstinence, intrauterine device) or have planned to donate sperm or ovum throughout the study period and within 3 months after the end of the study.
  11. Abnormal vital signs, lab and ECG indicators, as determined by the researcher, and clinically significant (e.g., male QTC > 450ms female > 470ms,corrected by Friericia ).
  12. Subjects who resting heart rate <55 beats/min or >100 beats/min; systolic blood pressure <90mmHg or >140mmHg; diastolic blood pressure <60mmHg or >90mmHg.
  13. Subjects who hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or HIV antibody (HIV-Ab), or syphilis serum reaction (TRUST) is non-negative.
  14. Subjects who glutamic-pyruvic transaminase(ALT), creatinine (Cr), urea nitrogen (BUN) exceeding the normal upper limit or the level of serum prolactin is 2 times higher than the normal upper limit.
  15. Subjects who participated in any clinical trial within 3 months before medication.
  16. Subjects have history of blood donations of 400 mL within 3 months before enrollment; 200 mL within 1 month before enrollment; or have history of using blood products.
  17. Subjects who had a history of surgery within 3 months prior to enrollment, or did not recover from surgery, or had an expected surgical plan during the study period.
  18. Subjects who had taken any drugs, including prescription and over-the-counter drugs within 2 weeks prior to enrollment.
  19. Subjects who directly related to this clinical trial.
  20. Subjects have poor compliance or other problems that the researchers believe that it is not suitable for participating.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:顺序分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:0.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
其他名称:
  • 安慰剂
实验性的:1.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
其他名称:
  • 安慰剂
实验性的:4.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
其他名称:
  • 安慰剂
实验性的:10mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
其他名称:
  • 安慰剂
实验性的:18mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
其他名称:
  • 安慰剂
实验性的:24mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
其他名称:
  • 安慰剂

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of AEs
大体时间:pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Incidence of Adverse Events
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose

次要结果测量

结果测量
措施说明
大体时间
Cmax
大体时间:pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Maximum (peak) observed drug serum concentration
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
AUC0-t
大体时间:pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Area under the concentration-time curve from time zero (pre-dose) to the time of the dosing interval
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
AUC0-∞
大体时间:pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
%AUCex
大体时间:pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Extrapolation percentage of AUC0-∞
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Tmax
大体时间:pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Time of occurrence of Cmax
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
T1/2
大体时间:pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Vd
大体时间:pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Apparent volume of distribution
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
CL
大体时间:pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Clearance
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
λz
大体时间:pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Elimination rate constant
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Hua Fang li, MD、Shanghai Mental Health Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月2日

初级完成 (预期的)

2021年8月1日

研究完成 (预期的)

2021年8月1日

研究注册日期

首次提交

2021年4月6日

首先提交符合 QC 标准的

2021年4月7日

首次发布 (实际的)

2021年4月9日

研究记录更新

最后更新发布 (实际的)

2021年4月9日

上次提交的符合 QC 标准的更新

2021年4月7日

最后验证

2021年4月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

0.5mg CY150112的临床试验

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