ACTRN12616000084482已完成不适用
A randomized, double-blind, parallel, single dose comparative pharmacokinetic study of two humanized monoclonal antibodies targeting HER2 receptors (i.e. trastuzumab) in healthy adult male subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Male
入选标准
- •Signed and dated written informed consent prior to any study-specific procedures, ability to understand and willingness to comply with the study procedures, restrictions
- •and requirements as judged and confirmed by the Investigator
- •- Healthy adult male subjects, 18 to 55 years (both inclusive) of age at the time of signing informed consent.
- •- Having body mass index (BMI) between 18-30 kg/m2 and body weight between 50 – 100 kg (all inclusive).
- •- Subjects with no clinically relevant abnormalities detected during baseline history, physical examination and vital signs (blood pressure, pulse rate, body temperature, including respiratory rate).
- •- Subjects who are considered healthy as determined by clinically acceptable findings of hemogram, biochemistry, coagulation tests, negative serology (HIV, Hepatitis B and
- •Hepatitis C), urinalysis, 12 lead ECG and echocardiogram.
- •- Subjects having normal thyroid function (subjects on thyroid supplementation therapy are not allowed for study participation).
- •- Subjects must refrain from donating sperm or fathering a child during the study and until 6 months after the last study drug (DRL_TZ and EU-approved Herceptin Registered Trademark) administration by agreeing to use (with their female partner) 02 acceptable contraceptives such as intrauterine device (IUD); oral, transdermal, injected, or implanted contraceptive; condoms; occlusive cap (diaphragm or cervical vault caps); spermicidal foam/gel/cream, etc.
- •- Non-smokers or ex-smokers who have not smoked within the previous 6 months from the screening visit and who agree to continue to abstain from smoking and using tobacco products throughout the course of the study.
排除标准
- •- Known history of hypersensitivity or allergic reactions to trastuzumab or any of its excipients.
- •- History of cardiovascular, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological, psychiatric or any other disease which in the opinion of the investigator would make the subject inappropriate for study participation.
- •- Abnormal and clinically relevant (in the opinion of the Investigator) ECG, history of angina, exertional dyspnea, orthopnoea, congestive heart failure or myocardial infarction.
- •- History of any cancer, including carcinoma in situ.
- •- Use of prescription or non-prescription drugs, including herbal and dietary supplements (including St. John’s Wort, but with the exception of paracetamol at doses up to 4 grams
- •per day, or vitamins) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise subject safety.
- •- Use of haematopoetic growth factors, monoclonal antibodies or immunoglobulins within last 6 months or 5 half-lives, whichever is longer.
- •- Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration.
- •- Difficulty in blood sampling or difficulty in accessibility of veins.
- •- Prior history of or current alcohol abuse or excessive intake of alcohol (defined as alcohol intake of > 3 standard drinks/day) and/or a positive test result in breath alcohol test
- •done before check-in.
- •- Positive test result for cotinine (>500 ng/ml) or drugs of abuse at screening or on admission to the study centre.
- •- Blood donation within 90 days prior to commencement of
- •study and during the study.
- •- Participation in an investigational antibody based study within 120 days and any other investigational study within 90 days prior to dosing.
- •- Participation in a study with trastuzumab or HER 2 targeted antibody or any prior exposure to these drugs.
研究者
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