Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects
2018年9月29日 更新者:Tianjin Hemay Bio-Tech Co., Ltd
A Randomised, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics of Hemay005 in Healthy Subjects
Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis.
A total of approximately 24 subjects will be randomized into 3 cohorts(15mg, 30mg, 60mg), approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose cohort.
This study includes an 28-day Screening Period, a 1-day single dose and 7-days multiple doses Treatment Period, and an End of Study Visit occurring approximately 11days (±3 days) after study drug administration.
研究概览
研究类型
介入性
注册 (预期的)
24
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:Hongyun Wang, Doctor
- 电话号码:010-69156576
- 邮箱:wanghy@pumch.cn
学习地点
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Beijing、中国
- 招聘中
- Peking Union Medical College Hospital
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接触:
- Hongyun Wang, Doctor
- 电话号码:010-69156576
- 邮箱:wanghy@pumch.cn
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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 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy subjects aged 18 to 60 years, male and female volunteers;
- Male Bodyweight(BW)≥ 50kg, female Bodyweight(BW)≥ 45kg, Body mass index (BMI) in 18-28 (including upper and lower limit of the range);
- All male subjects must agree and commit to the use of a reliable contraceptive regimen(including vasoligation, abstinence, using a condom) for the duration of the study(from screening until 6 months after the last dose), Female participants with a negative pregnancy test (serum) at both the screening visit and at Day-1, Female subjects and female partners of male subjects must agree and commit to the use of a reliable contraceptive regimen ( oral contraceptive medications or non-oral contraceptive medications) for the duration of the study(from screening until 6 months after the last dose);
- Ability to understand and be willing to sign a written informed consent before study entry;
- Subjects would have good communication with the investigator and could comply with protocol.
Exclusion Criteria:
- A history of clinically severe gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders;
- Have a known history of hypersensitivity to any medicine or food, or allergy to the test article or any of the excipient of the test article;
- Have a gastrointestinal, hepatic or renal condition that may influence drug absorption or metabolism;
- A history of chronic infection (ie, tuberculosis);
- A medical history of any clinically significant medical disease or surgery within 4 weeks of the screening;
- Clinically significant laboratory abnormal results at screening or prior to the first dose of study drug;
- Clinically significant abnormal 12-lead ECG or vital signs ( systolic pressure <90 mmHg or >140 mmHg, diastolic pressure <50 mmHg or >90 mmHg; radial pulse rate <50 bpm or >100 bpm);
- Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening;
- Recent history of frequent alcohol consumption, defined by average intake of greater than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of spirits with 40% alcohol content, or 150 mL wine), Participants who are unable to abstain from smoking during the study or quitting smoking for less than 3 months;
- Positive urine screen for drug and cigarettes, positive breath test for alcohol;
- Subjects who use soft drugs (ie marijuana )within 3 months of the screening and entire study duration or hard drugs (ie cocaine, phencyclidine ) within 1 year of the screening and entire study duration;
- Dietary habits or food intolerances which will interfere with the requirements for participants to consume a standardised diet whilst confined to the clinical unit;
- Participants who eat special food (Including grapefruit and/or Xanthine diet) for 14 days prior to dosing or any caffeine containing food or drinks, i.e. chocolate for 48 hours prior to dosing or drinking alcohol for 24 hours prior to dosing and not will stop to intake above food and drinks;
- Use of any drug that inhibits or induces hepatic metabolism of drugs within 30 days of planned study drug administration and entire study duration (e.g. inducers: barbiturates, carbamazepine, rifampicin, phenytoin, glucocorticoid and omeprazole; inhibitors - Selective Serotonin Reuptake Inhibitors(SSRI )antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones and antihistamines);
- Participant who received any medicine within 14 days of the initial dose of study drug;
- Have received other clinical trials treatment within 3 months prior to study;
- Participants who have donated of blood (>400 mL) within 4 weeks of the study, or plan to donate of blood during of the study and 4 weeks after the study;
- Subjects cannot complete the study due to other reasons or by the investigator's judgment;
- Pregnancy or lactating females
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:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Hemay005
6 subjects in each cohort(15mg, 30mg, 60mg) will receive Hemay005
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Subjects will be randomized into 3 dose groups orally twice daily.
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安慰剂比较:Placebo
2 subjects in each cohort(15mg, 30mg, 60mg) will receive placebo
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Subjects will be randomized into 3 dose groups orally twice daily.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Number of adverse events and serious adverse events.
大体时间:Day1 up to Day20±3
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Day1 up to Day20±3
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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, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Maximum observed plasma concentration
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pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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area under the curve from time zero to the last quantifiable concentration
大体时间:pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
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pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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area under the curve from time zero extrapolated to infinity
大体时间:pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Area under the plasma concentration-time curve from time zero extrapolated to infinity
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pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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t1/2
大体时间:pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Terminal elimination half-life
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pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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clearance CL/F
大体时间:pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Apparent total plasma clearance
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pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Vz/F
大体时间:pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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Apparent total volume of distribution
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pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11
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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:Hongyun Wang, Doctor、Peking Union Medical College Hospital
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)
2018年7月10日
初级完成 (预期的)
2018年10月20日
研究完成 (预期的)
2018年12月1日
研究注册日期
首次提交
2018年6月17日
首先提交符合 QC 标准的
2018年6月17日
首次发布 (实际的)
2018年6月26日
研究记录更新
最后更新发布 (实际的)
2018年10月2日
上次提交的符合 QC 标准的更新
2018年9月29日
最后验证
2018年6月1日
更多信息
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.
Hemay005的临床试验
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Ganzhou Hemay Pharmaceutical Co., LtdHemay Pharmaceutical PTY. LTD.完全的