NL-OMON35365已完成不适用
Randomized, single dose, parallel group, bioequivalence study, comparing trastuzumab (Synthon BV, the Netherlands) to Herceptin® (Hoffmann-La Roche, Switzerland) infusion in healthy male volunteers following a placebo-controlled dose escalation period - FTMB dose escalation and bioequivalence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Synthon BV
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy males, 18-45 years of age
- •Body Mass Index (BMI) 18.5 to 30.0 kg/m2, inclusive;
- •Subject is available for the entire study period and will provide his written informed consent;
- •Physical examination without significant deviations;
- •Vital signs, Electro Cardiogram (ECG) and Echo Cardiogram (Echo) without significant deviations;
- •All laboratory screening results within the normal range or being assessed as non-significant by the attending physician.
- •Baseline LVEF > 55%.
排除标准
- •History and/or current presence of hypersensitivity or allergic reactions, spontaneous or following a drug administration;
- •History and/or current presence of cardiac conditions, or any abnormal echo cardiogram finding (e.g. regional wall motion abnormality or signs of hypertrophic cardiomyopathy);
- •History and/or current presence of significant gastrointestinal, renal, hepatic, cardiovascular or pulmonary disease;
- •Clinically significant illness within four weeks before study start;
- •Any significant clinical abnormality, including a positive test for HBsAg, HCV, or HIV;
- •Serious mental disease;
- •Drug, alcohol, solvents or caffeine abuse;
- •Smoking more than 10 cigarettes (or 2 cigars or 2 pipes) per day;
- •Regular use of medication for at least three months;
- •Use of organ-toxic drugs within three months before study start, or use of drugs with a well-defined potential for toxicity to a major organ or system (for example chloramphenicol, which may cause bone marrow suppression);
- •Any systemic prescription treatment within 14 days before study start;
- •Any systemic over-the-counter (OTC) drug treatment within 7 days before study start;
- •Loss of blood outside the limits of Sanquin within 3 months prior to screening;
- •Participation in another clinical trial within 3 months prior to the start of this study or more than 4 times a year;
- •Positive test for drugs of abuse at screening;
- •Any condition that in the opinion of the investigator could jeopardize the subject*s health and/or well-being.
研究者
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