ACTRN12616001165471已完成1 期
A Phase I, Ascending Dose Randomized, Blinded, Placebo-Controlled, Single-Center Study to evaluate the safety and tolerability of of Intravenous FDY-5301 in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
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 65 Years（—）
- 性别
- All
入选标准
- •1)Aged between 18 and 65 years (inclusive).
- •2)Subjects must be infertile or agree to the use of medically reliable contraceptive methods (i.e. double barrier) for the duration of the study and for 30 days after study completion.
- •3)Body Mass Index (BMI) 18-30 inclusive.
- •4)Euthyroid confirmed by thyroid function testing at screening.
- •5)Adequate venous access for venipuncture and cannulation for drug administration.
- •6)Fluent in the English language.
- •7)A creatinine clearance of greater than 75 mL/min
- •8)In good general health as determined by medical screening.
- •9)Ability to provide informed consent
排除标准
- •1)Any chronic illness requiring prescription medication.
- •2)Presence or history of any thyroid disorder or presence of goiter upon examination
- •3)History of and/or hypersensitivity reaction to iodide or iodide containing drugs
- •4)Participation in any investigational study within 30 days of Visit 1.
- •5)Have donated blood (usually 550 mL) within 30 days of study participation
- •6)The need to take any over-the-counter (OTC) medications or herbal/vitamin supplements for one week prior to the check-in visit, and during the study
- •7)The need to take any prescription medications for two weeks prior to the check-in visit, and during the study excluding oral contraceptives, or contraceptive implants.
- •8)Subjects who are unable to abstain from smoking during study confinement.
- •9)Females not using medically reliable contraceptive methods (i.e. double barrier) or those who are nursing or pregnant
- •10)Use of food and/or beverages that contain caffeine or other xanthines (e.g. coffee, tea, cola and chocolate) during the 24 hours prior to dose administration and whilst confined at the clinical facility.
- •11)Regular drinkers of more than four (4) units of alcohol daily or those who have consumed alcohol within 24 hours pre-dose and until study completion.
- •12)Acute illness requiring treatment within 30 days of study entry.
- •13)Any history of clinically significant chronic illness including heart failure, renal failure, or liver disease
- •14)Have a predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs.
- •15)Have a history of abnormal bleeding tendencies.
- •16)History of Hepatitis B, Hepatitis C, acute or chronic hepatitis, or history/demonstration of Human Immunodeficiency Virus (HIV) antibodies or AIDS
- •17)Current history of alcohol or drug abuse (licit or illicit); or positive urine drug and alcohol screen at screening and pre-dose
- •18)Have blood pressure readings (after resting for 5 minutes) outside a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside a range of 40-90 on two consecutive measurements
- •19)Have any evidence of organ dysfunction, or any deviation in clinical laboratory values which is confirmed on re-examination to be clinically significant (i.e. in the opinion of the investigator would jeopardize the safety of the subject or impact the validity of the study results).
- •20)Inability to provide informed consent.
研究者
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