NCT02581748已完成1 期
A Phase I Study to Evaluate the Safety and Tolerability of Different Dosages of HLX02 (Open-label Part) and to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US and Germany Sourced; Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects
Shanghai Henlius Biotech1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2015年9月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to infinity (AUCinf)
研究概览
简要总结
Assessment of safety of HLX02 at different doses. Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and German).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provide the singed informed consent form (ICF)
- •Healthy Chinese male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests)
- •Aged ≥18 and ≤45 years
- •Body mass index (BMI) ≥19 and ≤28 kg/m2
- •Weight ≥50 and ≤80 kg
- •Left ventricular ejection fraction (LVEF) falls within the normal range as measured by echocardiogram (ECHO) within 14 days prior to randomisation
- •Subjects must agree that they and their female spouse/partners will use reliable contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential from the time of the administration of investigational product (IP) until the completion of the study
- •Do not smoke or smoke fewer than 5 cigarettes daily within three months prior to screening; do not drink or drink less than 14 units of alcohol within six months prior to screening (1 unit of alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine)
排除标准
- •Any history of clinically serious diseases such as hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, oncologic, or allergic diseases
- •Clinically significant abnormalities in laboratory test results
- •Previous exposure to any monoclonal antibody or current use of any biologics
- •History of allergic or anaphylactic reactions including those occurred during any clinical study or those caused by any drug or any of its excipients
- •Use of prescription or non prescription drugs and dietary supplements, within 5 half-lives of the drug or supplement, or within 2 weeks prior to taking IP (whichever is longer). Herbal supplements must be discontinued 28 days prior to the IP
- •History of a blood donation within 3 months prior to the administration of IP
- •Have participated in any other clinical study within 3 months prior to the administration of IP
- •Have positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies
- •Have a history of drug abuse
- •Unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits or improbability of completing the whole clinical study, etc.
研究组 & 干预措施
safety
Experimental
Assessment of safety of HLX02 at different doses
干预措施: HLX02 (Drug)
PK comparative
Active Comparator
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin®(U.S. and German)
干预措施: HLX02 (Drug)
PK comparative
Active Comparator
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin®(U.S. and German)
干预措施: Herceptin (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to infinity (AUCinf)
时间窗: 57 days
次要结局
- Adverse event frequencies(57 days)
- Maximum serum concentration (Cmax)(57 days)
- Time to Cmax (Tmax)(57 days)
- Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)(57 days)
研究者
研究点 (1)
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