ACTRN12618001509257招募中1 期
A multi-center, double-blinded, randomized, placebo-controlled, single ascending dose study with food effect crossover and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and hemostatic profile of VE-01902
VCR10 个研究点目标入组 134 人开始时间: 2018年9月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 134
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Male or female aged 18 to 55 years, inclusive;
- •2. Body mass index (BMI) between 19 and 33 kg/m2 inclusive, with a minimum weight of 50 kg;
- •3. Healthy as determined by pre-study medical history, physical examination, vital signs,
- •complete neurological examination and 12-lead electrocardiogram (ECG) confirming normal sinus rhythm;
- •4. Negative tests for Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV)
- •and human immunodeficiency virus (HIV)-1and HIV-2 antibody at screening;
- •5. Routine laboratory screening tests as specified below should be within normal limits or any abnormalities should be not clinically significant, as determined by the investigator at screening and day -1; however, results of the coagulation panel, platelet count and hemoglobin should be within normal limits, and liver function tests (specifically, total bilirubin, ALT and AST) should not exceed 1.5x the upper limit of normal;
- •6. Negative screen for alcohol and drugs of abuse at screening and admission;
- •7. Non-smokers or casual smoker who uses no more than 10 cigarettes (or equivalent quantity of any other nicotine containing products e.g. cigars, chewing tobacco, snuff, vaping, e-cigarettes, and etc.) per week. Subject must abstain from smoking 5 days prior to admission and throughout the entire study period, and test negative on Day -1 for urine cotinine test. ;
- •Female participants:
- •8. Must be of non-child-bearing potential by surgical sterilization or postmenopausal (no menses for the previous 12 months without alternative medical cause and confirmed by FSH testing),
- •9. Must not be pregnant, breast feeding, or planning to become pregnant AND must be practicing both a highly effective method of birth control for at least 30 days after the last dose of study drug and a barrier method (such as condom use). Highly-effective methods of birth control include: hormonal contraception (e.g. birth control pill, injection, implant, transdermal patch or vaginal ring), an intrauterine device, tubal ligation or a sole partner with a vasectomy. Progestin-based contraception that suppresses ovulation (e.g. Depo-Provera) is allowed. Estrogen-containing contraceptives that provide suppression of ovulation may be allowed. However, high-dose estrogen (greater than 35 microgram ethinyloestradiol)-containing contraceptives are not allowed in this study. Gonadotropin-releasing hormone agonist contraceptives are not allowed in this study. Abstinence from penile-vaginal intercourse for the above duration is acceptable, if it is consistent with the usual and preferred lifestyle of the participant;
- •10. Negative serum pregnancy test at screening and negative urine pregnancy test on admission of each treatment period (women of childbearing potential only);
- •Male participants:
- •11. Must be practicing a highly effective method of birth control with female partners of
- •childbearing potential from screening throughout the study and for at least 90 days after the last investigational drug administration. Highly effective birth control methods are as described above and include vasectomy, or condom use in combination with partner’s use of highly effective contraception
排除标准
- •If any of the following exclusion criteria apply, the volunteer must not enter/continue in the study:
- •1.Aspirin or Non-steroidal anti-inflammatory drug (with the exception of acetaminophen) use in the preceding 2 weeks.
- •2.Have used any anticoagulants independent of participating in a clinical trial, or if anticoagulant use was due to participation in a clinical trial then washout period should be maximum of the longer period of either 5x PK t1/2 or PD t1/2
- •3.Have any significant hematologic past medical history of hypercoagulable or bleeding disorders, unexplained bleeding, bruising, hemorrhage, blood clots, or thromboembolism as determined by the PI;
- •4.Have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
- •5.Have a clinically relevant surgical history (surgery within the last 2 months, planned surgery within the following month);
- •6.Have a history of hyperemesis, Crohn’s, Inflammatory Bowel Disease, Irritable Bowel Syndrome, hematuria, melena, hematochezia;
- •7.Have a history of severe drug allergy or hypersensitivity or food allergy, including anaphylaxis;
- •8.Have a history of alcoholism or drug abuse;
- •9.Consume more than 14 units of alcohol a week (1 unit of EtOH = 1 glass (25 cl) of beer with 3% of alcohol = 7.5 g, or 1 glass (25 cl) of beer with 6% of alcohol = 15 g, or 1 glass (12.5 cl) of wine with 10% of alcohol = 12 g, or 1 glass (4cl) of aperitif with 42% of alcohol = 17 g] on history, or exhibit detectable alcohol levels by breathalyzer;
- •10.Have a significant infection or known inflammatory process on screening or admission (ie. infection, autoimmune disease, immunosuppression regimen);
- •11.Have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or admission;
- •12.Have used any prescription medicines, over the counter medicines, or herbal supplements, within two weeks of admission, with the exception of acetaminophen or approved method of hormonal contraception;
- •13.Have used any investigational drug or participated in any clinical trial within 90 days prior (or if longer, 5 times the half life of the investigational product) to screening;
- •14.Have participated in more than 1 clinical trial within the 3 months prior to screening;
- •15.Have donated or received any blood or blood products within the 3 months prior to screening;
- •16.Have medical dietary restrictions that cannot be accommodated by the clinical unit;
- •17.Are an employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.
- •18.Cannot communicate reliably with the investigator;
- •19.Are unlikely to co-operate with the requirements, including duration of admission to the study and expected follow up visit;
- •20.Are unwilling or unable to give written informed consent.
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