ACTRN12611001171909招募中1 期
A randomised, double blind, parallel group, comparative Phase I study to evaluate the safety and pharmacokinetics of a single intravenous dose of GB221 compared to Herceptin Registered Trademark (trastuzumab) in healthy volunteers.
Genor Biopharma0 个研究点目标入组 32 人开始时间: 2011年11月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
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
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •1. Males aged 18 to 45 years.
- •2. Healthy as judged by medical examination and medical history, and clinical chemistry and haematology screening.
- •3. Body weight within the normal range for height (BMI between 19.0 and 29.0, inclusive) up to a maximum of 90 kg.
- •4. Normal or non-clinically significant ECG.
- •5. Normotensive (systolic: 90 - 140; diastolic: 50 - 90 mm Hg, inclusive) and heart rate (40 -100 bpm, inclusive).
- •6. Willingness to give written and informed consent prior to any study-related procedures being conducted
排除标准
- •1. Receipt of any investigational agent or drug within 4 weeks of entry to the study.
- •Use of any medicine – prescription, over-the-counter or herbal – in the 7 days prior to the treatment day and until 12 weeks after the treatment day.
- •3. Donation of blood (or loss of blood) greater than 400 ml within 3 months of the study.
- •4. Clinically significant drug allergy or sensitivity to any medication.
- •5. A history of chronic or recurrent infections.
- •6. A recent history of surgery.
- •7. History or presence of malignancy (with the exception of successfully treated basal cell carcinoma).
- •8. Inability to communicate or cooperate with the Principal Investigator because of English language difficulties or poor mental development.
- •9. A history (within the last 5 years) or evidence of alcohol or drug abuse (excepting tobacco use less than 10 cigarettes per day).
- •10. A positive urine test for drugs of abuse or alcohol either at screening or on the day of admittance for drug administration.
- •11. Vaccination of any type within the previous month.
- •12. A history of major psychiatric illness (such as bipolar disorder, schizophrenia or persistent major depression). Previous minor depression/adjustment disorder is acceptable if currently asymptomatic.
- •13. Consumption of more than 3 standard drinks per day, and not able to abstain from alcohol totally within 24 hours of dose administration.
- •14. Presence of current infection with tuberculosis, Hepatitis B, Hepatitis C or HIV.
- •15. History of asthma or other chronic respiratory disease in the past 5 years.
- •16. History of neurological or neuromuscular disease.
- •17. History of hypertension or cardiovascular disease, including congestive heart failure and cardiomyopathy or a clinically significant echocardiogram finding at the screening visit.
- •18. History of bladder or urethral disease.
- •19. Smoking cigarettes > 10 per day.
- •20. Any other condition which in the view of the Principal Investigator is likely to interfere with the study or put the subject at risk.
研究者
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