ACTRN12619001756112招募中1 期
A Randomized, Double Blind and Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIR1-365 after Oral Administrations in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
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
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1.Are capable of signing informed consent form (ICF) and complying with study procedures;
- •2.Women of childbearing potential (WOCBP) must have a negative pregnancy test and be practicing a medically acceptable method of contraception. All male patients with female partners of child-bearing potential must use two acceptable methods of contraception, during and for 3 months after participation in the study.
- •3.Nonsmoker, defined as not having smoked more than 2 cigarettes a day during the 6 months before screening. During the study, subject should be able to limit the use of tobacco products to 2 cigarettes a day;
- •4.Able to abstain from the consumption of alcohol and any alcohol-containing products from 48 hours before dosing through the end of the study;
- •5.Able to limit the consumption of coffee and any caffeine-containing products to four cups a day during the study;
- •6.Body mass index (BMI) of 18 to 32 kg/m2 inclusive and body weight not less than 50 kg;
排除标准
- •1.Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity
- •2.Clinically significant findings of screening clinical safety laboratory tests
- •3.Subjects with a mean systolic blood pressure of three measurements >150 mmHg, or a mean diastolic blood pressure of three measurements >90 mmHg at screening. Blood pressure will be measured at sitting position
- •4.Known or suspected malignancy, except adequately treated basal cell carcinoma
- •5.Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- •6.A history of seizure. However, a history of febrile seizure is allowed
- •7.A hospital admission or major surgery within 60 days prior to screening
- •8.Participation in any other investigational drug trial within 30 days prior to screening
- •9.DSM-V substance use disorders within 6 months prior to screening
- •10.A positive result for alcohol or drugs of abuse at screening or admission.
- •11.Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 30 days prior to screening
- •12.Use of prescription or over-the-counter (OTC) medications, and herbal medicines within 30 days prior to dosing
- •13.A history of suicide attempt in the past 12 months and/or seen by the investigator as having a significant history of risk of suicide or homicide
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