NCT03242239已完成1 期
A Randomized, Double-Blind, Parallel, Phase I Pharmacokinetic Trial Comparing The Potential Biosimilar ALT02(Trastuzumab) With Herceptin in Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- AUC0-inf: area under the concentration-time curve from time zero to infinity
研究概览
简要总结
The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and immunogenicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •Have a body weight over 50.0 kg and a body mass index over than 18.5 and less than 30.0 kg/m², inclusive.
排除标准
- •Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- •Positive urine drug screen or alcohol breath test at screening.
- •History of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or other related drugs.
- •Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
- •Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- •History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
- •History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening.
- •Use of trastuzumab or another monoclonal antibody for a medical condition or in the context of another clinical trial.
- •Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
- •Use of medication other than topical products without significant systemic absorption:
- •prescription medication within 14 days prior to dose administration;
- •over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
- •a depot injection or an implant of any drug within 3 months prior to dose administration.
- •Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing.
- •Hemoglobin <128 g/L and hematocrit <0.37 L/L at screening.
研究组 & 干预措施
EU-licensed Herceptin
Active Comparator
干预措施: EU-licensed Herceptin (Biological)
US-licensed Herceptin
Active Comparator
干预措施: US-licensed Herceptin (Biological)
ALT02
Experimental
干预措施: ALT02 (Biological)
结局指标
主要结局
AUC0-inf: area under the concentration-time curve from time zero to infinity
时间窗: 43 days
次要结局
- Kel: apparent terminal elimination rate constant(43 days)
- T½ el: apparent terminal half-life(43 days)
- AUC0-t: area under the concentration-time curve from time zero to the last non-zero concentration(43 days)
- CL: apparent body clearance, calculated as Dose/AUC0-inf(43 days)
- Vd: apparent volume of distribution, calculated as Dose/(kel x AUC0-inf)(43 days)
- Cmax: maximum observed concentration(43 days)
- Tmax: time of observed Cmax(43 days)
研究者
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